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Stem definition	Drug id	CAS RN
local anaesthetics	432	38396-39-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: bupivacaine hydrochloride anhydrous bupivacaine (+/-)-Bupivacaine bucain bupivan carbostesin DL-Bupivacaine bupivacaine hydrochloride bupivacaine HCl	A widely used local anesthetic agent. Molecular weight: 288.44 Formula: C18H28N2O CLOGP: 3.69 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 32.34 ALOGS: -3.47 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

bupivacaine hydrochloride anhydrous
bupivacaine
(+/-)-Bupivacaine
bucain
bupivan
carbostesin
DL-Bupivacaine
bupivacaine hydrochloride
bupivacaine HCl

A widely used local anesthetic agent.

Molecular weight: 288.44
Formula: C18H28N2O
CLOGP: 3.69
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 32.34
ALOGS: -3.47
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.18 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	13.00 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	0 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.84 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	4.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.06 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	3.10 hours	Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	3.251		High	0.86
caco2-efflux	Caco-2 efflux ratio (BA/AB)	0.374		High	0.86
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	52.966	10^-6 cm/s	High	0.86
dh-clint	Dog hepatocyte intrinsic clearance	133.968	uL/min/10^6 cells	High	0.86
dppb	Dog plasma protein binding (% unbound)	17.020	%	High	0.86
fcs-ppb	Fetal calf serum protein binding (% unbound)	32.070	%	High	0.86
herg	hERG pIC50	4.851	pIC50	High	0.86
hh-clint	Human hepatocyte intrinsic clearance	24.434	uL/min/10^6 cells	High	0.86
hlm-clint	Human liver microsomal intrinsic clearance	192.752	uL/min/mg protein	High	0.86
hppb	Human plasma protein binding (% unbound)	11.740	%	High	0.86
kinase-safety-class	ACVR2B,AXL,BRAF,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,EIF2AK3,EPHB4,ERBB2,GRK2,MAPK7,MAPKAPK2,NTRK2,PDK2,PDK4,PIK3CB,PRKDC,SIK2,SIK3,TEK	22
kinase-selectivity-class	AXL,BRAF,DDR1,EPHB4,ERBB2,GRK2,MAPK7,PDK4,SIK2,SIK3	10
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	0.551		High	0.86
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	0.328		High	0.86
mh-clint	Mouse hepatocyte intrinsic clearance	319.890		High	0.86
mppb	Mouse plasma protein binding (% unbound)	24.490		High	0.86
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	0.752		High	0.86
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	0		High	1
pppb	Pig plasma protein binding (% unbound)	33.850	%	High	0.86
rat-kpuu-brain	Rat brain Kpuu	1.426	%	High	0.86
rh-clint	Rat hepatocyte intrinsic clearance	286.418	uL/min/10^6 cells	High	0.86
rh-fuinc	Rat hepatocyte fraction unbound in incubation	76.230	%	High	0.86
rppb	Rat plasma protein binding (% unbound)	22.110	%	High	0.86
solubility-dd	Solubility at pH 7.4 in DMSO	501.187	uM	High	0.86

Approvals:

Date	Agency	Company	Orphan
Oct. 3, 1972	FDA	HOSPIRA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Anaesthetic complication	2132.41	13.69	392	22853	2073	90603129
Maternal exposure during delivery	1349.63	13.69	288	22957	3558	90601644
Exposure during pregnancy	594.88	13.69	490	22755	237920	90367282
Maternal exposure during pregnancy	522.88	13.69	547	22698	359516	90245686
Hypotension	489.60	13.69	504	22741	324893	90280309
Local anaesthetic systemic toxicity	458.87	13.69	118	23127	3382	90601820
Drug ineffective	409.33	13.69	1009	22236	1383289	89221913
Chondrolysis	317.73	13.69	55	23190	190	90605012
Bradycardia	250.46	13.69	192	23053	83655	90521547
Cauda equina syndrome	218.41	13.69	54	23191	1313	90603889
Incorrect route of product administration	208.62	13.69	141	23104	50485	90554717
Anterior spinal artery syndrome	206.76	13.69	37	23208	162	90605040
Premature delivery	201.67	13.69	125	23120	38637	90566565
Drug withdrawal syndrome	155.43	13.69	95	23150	28628	90576574
Overlap syndrome	147.48	13.69	62	23183	8486	90596716
Cardiac arrest	147.16	13.69	157	23088	104778	90500424
Paralysis	145.40	13.69	67	23178	11411	90593791
Normal newborn	141.28	13.69	83	23162	23279	90581923
Wrong product administered	136.95	13.69	57	23188	7608	90597594
Labelled drug-drug interaction medication error	133.06	13.69	68	23177	14514	90590688
Respiratory depression	123.19	13.69	66	23179	15509	90589693
Unresponsive to stimuli	119.69	13.69	90	23155	38031	90567171
Implant site extravasation	119.55	13.69	28	23217	537	90604665
Procedural hypotension	112.21	13.69	33	23212	1567	90603635
Diarrhoea	105.40	13.69	55	23190	939135	89666067
Myoclonus	105.24	13.69	64	23181	19104	90586098
Extradural haematoma	103.86	13.69	33	23212	2035	90603167
Rhythm idioventricular	101.66	13.69	23	23222	376	90604826
Spinal cord injury	100.81	13.69	28	23217	1081	90604121
Caesarean section	94.29	13.69	59	23186	18518	90586684
Inadequate analgesia	93.21	13.69	34	23211	3190	90602012
Apnoea	92.02	13.69	46	23199	9368	90595834
Generalised tonic-clonic seizure	89.24	13.69	73	23172	34830	90570372
Post lumbar puncture syndrome	87.78	13.69	24	23221	873	90604329
Lagophthalmos	87.41	13.69	21	23224	451	90604751
Ventilation perfusion mismatch	82.68	13.69	21	23224	571	90604631
Spinal cord infarction	82.10	13.69	19	23226	345	90604857
Hypoaesthesia	81.95	13.69	220	23025	313990	90291212
Delayed recovery from anaesthesia	80.01	13.69	23	23222	1007	90604195
Fatigue	79.87	13.69	108	23137	1153915	89451287
Arachnoiditis	77.98	13.69	20	23225	566	90604636
Seizure	77.77	13.69	140	23105	152489	90452713
Urinary retention	72.37	13.69	67	23178	37677	90567525
Rheumatoid arthritis	70.72	13.69	6	23239	362608	90242594
Anaphylactic shock	70.26	13.69	61	23184	31556	90573646
Hyperaesthesia	69.94	13.69	40	23205	10662	90594540
Paraplegia	69.93	13.69	28	23217	3384	90601818
Loss of consciousness	69.36	13.69	127	23118	140111	90465091
Medical device site pain	67.82	13.69	15	23230	220	90604982
Rash	67.54	13.69	63	23182	796037	89809165
Anaphylactic reaction	67.53	13.69	97	23148	87427	90517775
Live birth	67.47	13.69	92	23153	79015	90526187
Hypothermia	65.59	13.69	44	23201	15531	90589671
Circulatory collapse	65.58	13.69	53	23192	24851	90580351
Premature baby	65.26	13.69	53	23192	25024	90580178
Purtscher retinopathy	62.74	13.69	13	23232	137	90605065
Sedation	62.11	13.69	69	23176	48102	90557100
Hypoxia	61.44	13.69	84	23161	72315	90532887
Procedural complication	61.25	13.69	30	23215	5848	90599354
Foetal exposure during delivery	60.65	13.69	15	23230	365	90604837
Brachial plexopathy	60.50	13.69	14	23231	254	90604948
Pneumonia	59.57	13.69	46	23199	638013	89967189
Therapeutic product effect prolonged	59.37	13.69	15	23230	399	90604803
Joint swelling	55.52	13.69	30	23215	503270	90101932
Post procedural complication	55.45	13.69	43	23202	18999	90586203
Bradycardia foetal	54.41	13.69	15	23230	563	90604639
Parophthalmia	54.15	13.69	14	23231	409	90604793
Conjunctival oedema	50.89	13.69	16	23229	953	90604249
Sensory loss	50.86	13.69	40	23205	18035	90587167
Spinal anaesthesia	50.74	13.69	10	23235	80	90605122
Blood pressure decreased	50.59	13.69	78	23167	74817	90530385
No adverse event	50.47	13.69	74	23171	67908	90537294
Hypertensive encephalopathy	50.45	13.69	15	23230	740	90604462
Haemodynamic instability	49.04	13.69	33	23212	11706	90593496
Meningitis chemical	48.96	13.69	12	23233	281	90604921
Systemic lupus erythematosus	48.82	13.69	16	23229	361880	90243322
Platelet aggregation inhibition	48.72	13.69	11	23234	178	90605024
Diplegia	48.07	13.69	17	23228	1458	90603744
Horner's syndrome	47.07	13.69	8	23237	24	90605178
Uterine atony	46.91	13.69	12	23233	336	90604866
Neurotoxicity	46.85	13.69	41	23204	21426	90583776
Postpartum haemorrhage	46.78	13.69	19	23226	2382	90602820
Neuromuscular blockade	46.31	13.69	12	23233	354	90604848
Vascular resistance systemic decreased	46.12	13.69	10	23235	133	90605069
Arachnoid web	46.03	13.69	7	23238	7	90605195
Therapeutic product effect delayed	45.31	13.69	21	23224	3620	90601582
Peripheral swelling	44.99	13.69	25	23220	413081	90192121
Pemphigus	44.88	13.69	14	23231	326850	90278352
Overdose	44.69	13.69	114	23131	157595	90447607
Motor dysfunction	44.54	13.69	38	23207	19192	90586010
Pulseless electrical activity	44.40	13.69	28	23217	8904	90596298
Mental status changes postoperative	42.88	13.69	10	23235	188	90605014
Intracranial hypotension	42.08	13.69	11	23234	336	90604866
Exophthalmos	41.18	13.69	16	23229	1786	90603416
Neuralgia	40.39	13.69	45	23200	31455	90573747
Procedural pain	39.96	13.69	46	23199	33314	90571888
Stridor	39.84	13.69	21	23224	4772	90600430
Cough	39.21	13.69	23	23222	368939	90236263
Product dose omission issue	39.15	13.69	13	23232	291674	90313528
Monoplegia	39.02	13.69	19	23226	3655	90601547
Ventricular tachycardia	38.23	13.69	39	23206	24669	90580533
Neutropenia	38.16	13.69	6	23239	224898	90380304
Spinal cord oedema	37.74	13.69	9	23236	187	90605015
Arthropathy	37.29	13.69	24	23221	366218	90238984
Respiratory arrest	36.69	13.69	44	23201	33267	90571935
Myelitis	35.60	13.69	15	23230	2063	90603139
Accidental overdose	35.58	13.69	40	23205	28233	90576969
Acute kidney injury	35.44	13.69	19	23226	320368	90284834
Device infusion issue	35.16	13.69	16	23229	2646	90602556
Depressed level of consciousness	34.81	13.69	65	23180	72719	90532483
Synovitis	34.41	13.69	21	23224	329731	90275471
Spinal cord compression	33.83	13.69	19	23226	4892	90600310
Tachycardia	33.82	13.69	103	23142	157570	90447632
Mental status changes	33.69	13.69	49	23196	44630	90560572
Trigeminal palsy	33.68	13.69	7	23238	75	90605127
Low birth weight baby	33.42	13.69	24	23221	9443	90595759
Strabismus	33.12	13.69	15	23230	2453	90602749
Myelitis transverse	32.98	13.69	13	23232	1507	90603695
Complication associated with device	32.48	13.69	32	23213	19417	90585785
Fall	32.25	13.69	46	23199	481764	90123438
Necrotising fasciitis	32.25	13.69	17	23228	3863	90601339
Wound	32.02	13.69	19	23226	302961	90302241
Therapy non-responder	31.88	13.69	92	23153	136612	90468590
Respiratory rate decreased	31.83	13.69	17	23228	3966	90601236
Peripartum cardiomyopathy	31.76	13.69	8	23237	210	90604992
Ophthalmoplegia	31.22	13.69	13	23232	1736	90603466
Neuromuscular block prolonged	31.08	13.69	10	23235	642	90604560
Bezold-Jarisch reflex	30.90	13.69	6	23239	44	90605158
Sensory disturbance	30.78	13.69	28	23217	15385	90589817
Confusion postoperative	30.65	13.69	8	23237	243	90604959
Areflexia	30.35	13.69	16	23229	3637	90601565
Anaemia	29.73	13.69	28	23217	352774	90252428
Sensorimotor disorder	29.64	13.69	10	23235	745	90604457
Pyrexia	29.56	13.69	80	23165	660405	89944797
Muscular weakness	29.53	13.69	118	23127	206548	90398654
Cerebrospinal fluid leakage	29.16	13.69	12	23233	1555	90603647
Uterine hypertonus	28.70	13.69	8	23237	313	90604889
Pericarditis	28.46	13.69	17	23228	270134	90335068
Medical device site erythema	28.30	13.69	5	23240	20	90605182
Arteriospasm coronary	28.07	13.69	17	23228	5033	90600169
Urinary tract infection	27.25	13.69	23	23222	305609	90299593
Allodynia	26.66	13.69	10	23235	1014	90604188
Product formulation issue	26.63	13.69	9	23236	674	90604528
Kounis syndrome	26.51	13.69	13	23232	2540	90602662
Harlequin syndrome	26.40	13.69	7	23238	226	90604976
Contraindicated product administered	26.28	13.69	26	23219	320113	90285089
Nasopharyngitis	26.13	13.69	40	23205	407064	90198138
Lower respiratory tract infection	26.09	13.69	16	23229	250643	90354559
Bundle branch block left	25.59	13.69	19	23226	7866	90597336
Device failure	25.53	13.69	18	23227	6879	90598323
Product measured potency issue	25.52	13.69	6	23239	117	90605085
Death	25.51	13.69	49	23196	456502	90148700
Arthralgia	25.49	13.69	108	23137	778414	89826788
Influenza	25.31	13.69	3	23242	139261	90465941
Systemic toxicity	25.23	13.69	7	23238	269	90604933
Eclampsia	25.23	13.69	8	23237	490	90604712
Maternal drugs affecting foetus	25.22	13.69	16	23229	5139	90600063
Implant site infection	25.21	13.69	10	23235	1179	90604023
Febrile neutropenia	25.17	13.69	5	23240	158344	90446858
Product closure issue	25.03	13.69	4	23241	7	90605195
Adverse drug reaction	24.80	13.69	76	23169	116625	90488577
Anaesthetic complication cardiac	24.74	13.69	5	23240	46	90605156
Nerve block	24.55	13.69	9	23236	856	90604346
Gastrointestinal disorder	24.54	13.69	18	23227	256669	90348533
Product administration error	24.46	13.69	32	23213	26391	90578811
Vocal cord paralysis	24.12	13.69	12	23233	2418	90602784
Chondromalacia	23.95	13.69	7	23238	325	90604877
Hypercapnia	23.74	13.69	17	23228	6660	90598542
Weight decreased	23.74	13.69	38	23207	379872	90225330
Myopathy toxic	23.58	13.69	8	23237	606	90604596
Fanconi syndrome	23.54	13.69	11	23234	1932	90603270
Implant site pain	23.30	13.69	12	23233	2600	90602602
Malaise	23.29	13.69	75	23170	585911	90019291
White blood cell count decreased	23.21	13.69	7	23238	167102	90438100
Nervous system disorder	22.92	13.69	28	23217	21565	90583637
Respiratory acidosis	22.91	13.69	18	23227	8101	90597101
Off label use	22.89	13.69	403	22842	1101849	89503353
Obstetric procedure complication	22.45	13.69	4	23241	17	90605185
Maternal use of illicit drugs	22.26	13.69	4	23241	18	90605184
Glossodynia	22.23	13.69	30	23215	321749	90283453
Mean arterial pressure decreased	22.11	13.69	6	23239	212	90604990
Alopecia	22.10	13.69	60	23185	495011	90110191
Office visit	21.81	13.69	3	23242	0	90605202
Conus medullaris syndrome	21.81	13.69	3	23242	0	90605202
Respiratory distress	21.45	13.69	37	23208	38909	90566293
Arthrofibrosis	21.44	13.69	4	23241	23	90605179
Uterine haemorrhage	21.40	13.69	14	23231	4738	90600464
Hypoaesthesia oral	21.23	13.69	23	23222	15577	90589625
Hand deformity	21.12	13.69	27	23218	296335	90308867
Product quality issue	21.07	13.69	56	23189	79269	90525933
Cancer pain	20.97	13.69	13	23232	4012	90601190
Drug intolerance	20.92	13.69	53	23192	447538	90157664
Device alarm issue	20.78	13.69	10	23235	1875	90603327
Duodenal ulcer perforation	20.53	13.69	16	23229	221272	90383930
Incision site pain	20.49	13.69	9	23236	1369	90603833
Device malfunction	20.35	13.69	26	23219	20951	90584251
Completed suicide	20.28	13.69	6	23239	145052	90460150
COVID-19	20.19	13.69	9	23236	168834	90436368
Subdural haematoma	20.01	13.69	23	23222	16622	90588580
Blood pressure immeasurable	19.80	13.69	9	23236	1483	90603719
Pneumorrhachis	19.73	13.69	3	23242	3	90605199
Anti-cyclic citrullinated peptide antibody positive	19.63	13.69	19	23226	236414	90368788
Infusion site mass	19.36	13.69	10	23235	2179	90603023
Dose calculation error	19.29	13.69	6	23239	345	90604857
Disease progression	19.28	13.69	8	23237	156607	90448595
Abdominal discomfort	19.01	13.69	61	23184	477267	90127935
Peroneal nerve palsy	18.99	13.69	14	23231	5734	90599468
Withdrawal syndrome	18.90	13.69	26	23219	22498	90582704
Blood pressure systolic decreased	18.82	13.69	17	23228	9253	90595949
Agitation	18.47	13.69	48	23197	67050	90538152
Prescribed overdose	18.38	13.69	61	23184	97564	90507638
Pulse absent	18.34	13.69	14	23231	6041	90599161
Bradyarrhythmia	18.26	13.69	10	23235	2451	90602751
Manipulation	18.13	13.69	4	23241	58	90605144
Atrioventricular block complete	18.00	13.69	17	23228	9794	90595408
Quadriparesis	17.93	13.69	10	23235	2539	90602663
Ventricular fibrillation	17.89	13.69	20	23225	14024	90591178
Sphincter of Oddi dysfunction	17.74	13.69	6	23239	450	90604752
Weight increased	17.64	13.69	52	23193	417875	90187327
Ventricular hypokinesia	17.63	13.69	13	23232	5328	90599874
Spinal epidural haematoma	17.56	13.69	8	23237	1326	90603876
Rotator cuff syndrome	17.48	13.69	21	23224	15898	90589304
Psoriasis	17.47	13.69	8	23237	147746	90457456
Abdominal pain upper	17.46	13.69	37	23208	332637	90272565
Paresis	17.35	13.69	10	23235	2704	90602498
Intraocular pressure fluctuation	17.26	13.69	4	23241	73	90605129
Spinal cord haematoma	17.24	13.69	5	23240	226	90604976
Product packaging confusion	17.19	13.69	5	23240	228	90604974
Extra dose administered	17.11	13.69	16	23229	9102	90596100
Myalgia	17.10	13.69	12	23233	175113	90430089
Implant site haematoma	16.82	13.69	4	23241	82	90605120
Neurogenic shock	16.80	13.69	6	23239	530	90604672
Cardiac output increased	16.78	13.69	6	23239	531	90604671
Infusion related reaction	16.78	13.69	53	23192	416727	90188475
Pulmonary oedema	16.66	13.69	44	23201	62036	90543166
Wheezing	16.64	13.69	22	23223	238058	90367144
Wound dehiscence	16.63	13.69	13	23232	5809	90599393
Somnolence	16.62	13.69	101	23144	208983	90396219
Blood creatinine increased	16.54	13.69	3	23242	101383	90503819
Vasospasm	16.48	13.69	7	23238	982	90604220
Therapeutic product effect variable	16.47	13.69	8	23237	1531	90603671
Brain hypoxia	16.45	13.69	6	23239	563	90604639
Device kink	16.43	13.69	9	23236	2206	90602996
Hypovolaemia	16.35	13.69	18	23227	12413	90592789
Pre-eclampsia	16.30	13.69	17	23228	11031	90594171
Seroma	16.24	13.69	10	23235	3050	90602152
Retinal artery occlusion	16.22	13.69	9	23236	2262	90602940
Status epilepticus	16.15	13.69	22	23223	18852	90586350
Stroke volume increased	15.97	13.69	3	23242	18	90605184
Cardiac failure congestive	15.93	13.69	3	23242	98691	90506511
Hyponatraemic encephalopathy	15.85	13.69	5	23240	301	90604901
Arthritis bacterial	15.80	13.69	14	23231	7431	90597771
Contusion	15.80	13.69	25	23220	251191	90354011
Neurological procedural complication	15.70	13.69	3	23242	20	90605182
Foetal distress syndrome	15.69	13.69	8	23237	1697	90603505
Hypoglycaemia neonatal	15.63	13.69	7	23238	1115	90604087
Post procedural hypotension	15.45	13.69	3	23242	22	90605180
Renal impairment	15.41	13.69	4	23241	105417	90499785
Brain injury	15.34	13.69	14	23231	7724	90597478
Infection	15.32	13.69	45	23200	362049	90243153
Tinnitus	15.26	13.69	34	23211	43068	90562134
Sleep disorder	15.21	13.69	17	23228	198013	90407189
Phrenic nerve paralysis	15.19	13.69	5	23240	345	90604857
Anaesthetic complication neurological	14.90	13.69	6	23239	735	90604467
Thrombocytopenia	14.88	13.69	19	23226	208706	90396496
Therapeutic product effect increased	14.65	13.69	7	23238	1292	90603910
Product package associated injury	14.62	13.69	3	23242	30	90605172
Decreased ventricular preload	14.62	13.69	3	23242	30	90605172
Dehydration	14.60	13.69	17	23228	194430	90410772
Acute pulmonary oedema	14.60	13.69	15	23230	9565	90595637
Leukopenia	14.38	13.69	4	23241	100706	90504496
Sinus tachycardia	14.30	13.69	26	23219	28487	90576715
Cardio-respiratory arrest	14.24	13.69	42	23203	63098	90542104
Gastrooesophageal reflux disease	14.23	13.69	13	23232	166324	90438878
Left ventricle outflow tract obstruction	14.16	13.69	5	23240	427	90604775
Renal failure	14.14	13.69	8	23237	130999	90474203
Catatonia	14.09	13.69	12	23233	6044	90599158
Gastrointestinal haemorrhage	14.03	13.69	3	23242	90245	90514957
Rheumatoid factor positive	14.01	13.69	14	23231	171636	90433566
Oropharyngeal pain	13.99	13.69	6	23239	115181	90490021
Iatrogenic injury	13.99	13.69	6	23239	862	90604340
Incision site rash	13.90	13.69	3	23242	39	90605163
Granuloma	13.87	13.69	12	23233	6173	90599029
Liver injury	13.82	13.69	14	23231	170553	90434649
Ventricular extrasystoles	13.77	13.69	17	23228	13233	90591969
Loss of personal independence in daily activities	13.72	13.69	9	23236	136096	90469106
Brugada syndrome	13.70	13.69	5	23240	470	90604732

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Anaesthetic complication	767.47	21.48	150	9627	1307	42610251
Local anaesthetic systemic toxicity	258.31	21.48	67	9710	2233	42609325
Chondrolysis	257.99	21.48	41	9736	81	42611477
Drug withdrawal syndrome	142.40	21.48	78	9699	21471	42590087
Drug ineffective	124.94	21.48	370	9407	629827	41981731
Pain	124.34	21.48	210	9567	244638	42366920
Hyperaesthesia	113.75	21.48	45	9732	5907	42605651
Hypoaesthesia	106.79	21.48	105	9672	71358	42540200
Cauda equina syndrome	88.35	21.48	24	9753	956	42610602
Inspiratory capacity decreased	88.11	21.48	31	9746	2936	42608622
Myoclonus	81.39	21.48	50	9727	17015	42594543
Paralysis	80.65	21.48	37	9740	6983	42604575
Retinal artery occlusion	76.86	21.48	26	9751	2189	42609369
Respiratory depression	74.34	21.48	49	9728	18819	42592739
Incorrect route of product administration	72.04	21.48	53	9724	24252	42587306
Bradycardia	71.65	21.48	93	9684	85391	42526167
Cardiac arrest	67.91	21.48	103	9674	109217	42502341
Lagophthalmos	64.99	21.48	13	9764	128	42611430
Anal incontinence	64.82	21.48	35	9742	9346	42602212
Sinus arrest	62.01	21.48	22	9755	2134	42609424
Paraplegia	59.76	21.48	24	9753	3273	42608285
Hypotension	55.01	21.48	156	9621	257475	42354083
Cardiotoxicity	54.88	21.48	29	9748	7416	42604142
Spinal cord infarction	53.97	21.48	15	9762	651	42610907
Medical device site pain	51.97	21.48	10	9767	79	42611479
Device failure	49.83	21.48	20	9757	2723	42608835
Sensory loss	49.16	21.48	24	9753	5200	42606358
Kounis syndrome	49.15	21.48	21	9756	3347	42608211
Urinary incontinence	48.45	21.48	40	9737	21628	42589930
Apnoea	48.09	21.48	27	9750	7776	42603782
Post procedural hypotension	46.89	21.48	9	9768	70	42611488
Therapeutic product effect delayed	45.53	21.48	16	9761	1509	42610049
Neurotoxicity	45.40	21.48	40	9737	23611	42587947
Muscular weakness	45.32	21.48	74	9703	83424	42528134
Corneal reflex decreased	44.78	21.48	10	9767	173	42611385
Premature baby	44.13	21.48	39	9738	23114	42588444
Device malfunction	43.72	21.48	30	9747	12297	42599261
Generalised tonic-clonic seizure	43.56	21.48	41	9736	26338	42585220
Loss of consciousness	42.42	21.48	76	9701	92278	42519280
Arachnoiditis	41.91	21.48	11	9766	383	42611175
Delayed recovery from anaesthesia	41.65	21.48	14	9763	1155	42610403
Autonomic nervous system imbalance	40.80	21.48	18	9759	3098	42608460
Implant site pain	40.73	21.48	9	9768	148	42611410
Implant site extravasation	40.16	21.48	11	9766	452	42611106
Anaphylactic reaction	39.72	21.48	49	9728	42694	42568864
Pneumonia	39.63	21.48	24	9753	422125	42189433
Device infusion issue	38.41	21.48	13	9764	1095	42610463
Procedural pain	38.36	21.48	21	9756	5758	42605800
Sodium retention	38.25	21.48	8	9769	100	42611458
Spinal shock	37.91	21.48	7	9770	43	42611515
Areflexia	37.64	21.48	18	9759	3725	42607833
Oculocardiac reflex	37.08	21.48	8	9769	117	42611441
Therapy non-responder	37.00	21.48	53	9724	53306	42558252
Wrong product administered	36.90	21.48	21	9756	6205	42605353
Arthrofibrosis	35.97	21.48	7	9770	59	42611499
Sedation	35.08	21.48	39	9738	30436	42581122
Low birth weight baby	34.76	21.48	24	9753	9931	42601627
Anal sphincter atony	34.73	21.48	8	9769	160	42611398
Acute kidney injury	34.29	21.48	21	9756	367316	42244242
Amaurosis	33.57	21.48	11	9766	838	42610720
Renin increased	32.95	21.48	8	9769	202	42611356
Procedural complication	32.70	21.48	17	9760	4202	42607356
Anaemia	32.29	21.48	12	9765	280266	42331292
Post procedural complication	31.87	21.48	25	9752	12565	42598993
Labelled drug-drug interaction medication error	31.20	21.48	27	9750	15555	42596003
Myopathy toxic	30.92	21.48	10	9767	731	42610827
Unresponsive to stimuli	30.79	21.48	37	9740	31366	42580192
Paraparesis	30.50	21.48	13	9764	2058	42609500
Complication associated with device	30.38	21.48	19	9758	6662	42604896
Thrombocytopenia	30.17	21.48	4	9773	190275	42421283
Overdose	29.84	21.48	71	9706	105193	42506365
Paroxysmal sympathetic hyperactivity	29.73	21.48	6	9771	62	42611496
Symmetrical drug-related intertriginous and flexural exanthema	29.37	21.48	10	9767	858	42610700
Diaphragmatic paralysis	29.08	21.48	9	9768	570	42610988
Macular ischaemia	28.60	21.48	7	9770	183	42611375
Device power source issue	28.56	21.48	9	9768	605	42610953
Deafness bilateral	28.22	21.48	11	9766	1386	42610172
Diarrhoea	28.05	21.48	39	9738	460810	42150748
Infusion site mass	27.96	21.48	8	9769	386	42611172
Product administration error	27.43	21.48	27	9750	18316	42593242
Axillary pain	27.23	21.48	8	9769	424	42611134
Electrocardiogram T wave amplitude increased	27.02	21.48	6	9771	101	42611457
Anaesthetic complication neurological	26.96	21.48	9	9768	727	42610831
Death	26.61	21.48	42	9735	471143	42140415
Jaundice cholestatic	26.59	21.48	16	9761	5237	42606321
Sinus tachycardia	26.51	21.48	28	9749	20625	42590933
Muscle rigidity	26.40	21.48	22	9755	12037	42599521
Brief psychotic disorder with marked stressors	26.06	21.48	7	9770	267	42611291
No adverse event	25.94	21.48	38	9739	38983	42572575
Coma	25.76	21.48	45	9732	53509	42558049
Foetal exposure during delivery	25.59	21.48	6	9771	130	42611428
Mental status changes	25.13	21.48	39	9738	42076	42569482
Inadequate analgesia	25.12	21.48	13	9764	3184	42608374
Apgar score low	24.57	21.48	9	9768	956	42610602
Implant site erythema	24.49	21.48	5	9772	55	42611503
Brown-Sequard syndrome	24.41	21.48	5	9772	56	42611502
Foetal exposure during pregnancy	24.40	21.48	41	9736	47270	42564288
Tachycardia	24.25	21.48	64	9713	101023	42510535
Blood pressure decreased	24.24	21.48	46	9731	58286	42553272
Femoral nerve palsy	24.02	21.48	5	9772	61	42611497
Ventricular tachycardia	23.96	21.48	32	9745	30128	42581430
Hypercapnia	23.76	21.48	15	9762	5346	42606212
Phrenic nerve paralysis	23.47	21.48	6	9771	188	42611370
Hyperhidrosis	23.46	21.48	59	9718	90453	42521105
Ophthalmoplegia	23.41	21.48	11	9766	2189	42609369
Open globe injury	22.87	21.48	5	9772	78	42611480
Strabismus	22.73	21.48	11	9766	2337	42609221
Meningitis chemical	22.25	21.48	5	9772	89	42611469
Somnolence	22.20	21.48	77	9700	141028	42470530
Pre-existing disease	22.15	21.48	5	9772	91	42611467
Bezold-Jarisch reflex	22.14	21.48	3	9774	0	42611558
Catheter site mass	21.89	21.48	4	9773	23	42611535
Chondromalacia	21.89	21.48	4	9773	23	42611535
Hypothermia	21.71	21.48	20	9757	12495	42599063

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Anaesthetic complication	2310.64	13.69	446	28132	3160	110557561
Maternal exposure during delivery	1147.27	13.69	249	28329	3316	110557405
Maternal exposure during pregnancy	601.15	13.69	509	28069	254374	110306347
Chondrolysis	552.22	13.69	94	28484	283	110560438
Local anaesthetic systemic toxicity	466.97	13.69	132	28446	5405	110555316
Exposure during pregnancy	333.16	13.69	304	28274	167120	110393601
Drug ineffective	311.00	13.69	976	27602	1519564	109041157
Hypotension	300.30	13.69	507	28071	523342	110037379
Cauda equina syndrome	284.70	13.69	73	28505	2049	110558672
Drug withdrawal syndrome	268.90	13.69	150	28428	37904	110522817
Bradycardia	255.31	13.69	254	28324	155263	110405458
Incorrect route of product administration	247.60	13.69	172	28406	63889	110496832
Anterior spinal artery syndrome	215.44	13.69	39	28539	183	110560538
Paralysis	212.53	13.69	96	28482	15504	110545217
Premature delivery	208.94	13.69	118	28460	30514	110530207
Cardiac arrest	190.19	13.69	244	28334	196509	110364212
Myoclonus	182.57	13.69	111	28467	32887	110527834
Hyperaesthesia	176.75	13.69	83	28495	14644	110546077
Respiratory depression	167.74	13.69	104	28474	31897	110528824
Lagophthalmos	150.36	13.69	34	28544	550	110560171
Overlap syndrome	146.84	13.69	63	28515	8996	110551725
Normal newborn	145.68	13.69	83	28495	21813	110538908
Implant site extravasation	139.68	13.69	35	28543	893	110559828
Hypoaesthesia	136.23	13.69	270	28308	313953	110246768
Apnoea	128.04	13.69	65	28513	13574	110547147
Wrong product administered	120.01	13.69	58	28520	10902	110549819
Spinal cord infarction	119.52	13.69	32	28546	1066	110559655
Spinal cord injury	119.41	13.69	35	28543	1630	110559091
Unresponsive to stimuli	117.33	13.69	111	28467	63679	110497042
Extradural haematoma	114.00	13.69	40	28538	3329	110557392
Diarrhoea	113.67	13.69	78	28500	1139427	109421294
Arachnoiditis	111.63	13.69	30	28548	1014	110559707
Paraplegia	110.07	13.69	46	28532	6154	110554567
Delayed recovery from anaesthesia	109.56	13.69	35	28543	2180	110558541
Anaphylactic reaction	109.16	13.69	141	28437	114159	110446562
Loss of consciousness	106.71	13.69	186	28392	196120	110364601
Generalised tonic-clonic seizure	106.05	13.69	98	28480	54582	110506139
Inadequate analgesia	104.92	13.69	42	28536	5035	110555686
Medical device site pain	101.72	13.69	23	28555	372	110560349
Pneumonia	95.64	13.69	54	28524	876660	109684061
Post lumbar puncture syndrome	91.78	13.69	26	28552	1071	110559650
Sedation	91.29	13.69	101	28477	69582	110491139
Labelled drug-drug interaction medication error	88.90	13.69	68	28510	29234	110531487
Retinal artery occlusion	87.28	13.69	35	28543	4214	110556507
Sensory loss	86.11	13.69	59	28519	21398	110539323
Rhythm idioventricular	86.02	13.69	23	28555	762	110559959
Fatigue	80.35	13.69	119	28459	1215839	109344882
Acute kidney injury	78.56	13.69	33	28545	635397	109925324
Ventilation perfusion mismatch	76.33	13.69	21	28557	776	110559945
Kounis syndrome	72.96	13.69	34	28544	5891	110554830
Procedural complication	72.95	13.69	38	28540	8367	110552354
Device failure	72.50	13.69	36	28542	7171	110553550
Neutropenia	71.56	13.69	7	28571	374613	110186108
Hypothermia	71.06	13.69	57	28521	26245	110534476
Seizure	70.50	13.69	168	28410	221017	110339704
Post procedural complication	70.38	13.69	57	28521	26601	110534120
Anaphylactic shock	69.74	13.69	76	28502	51470	110509251
Caesarean section	67.60	13.69	43	28535	13774	110546947
Neurotoxicity	67.41	13.69	68	28510	42139	110518582
Meningitis chemical	66.02	13.69	16	28562	354	110560367
Device infusion issue	65.74	13.69	26	28552	3019	110557702
Brachial plexopathy	63.76	13.69	15	28563	291	110560430
Febrile neutropenia	62.98	13.69	5	28573	316762	110243959
Muscular weakness	62.89	13.69	173	28405	248295	110312426
No adverse event	62.65	13.69	86	28492	73753	110486968
Diplegia	61.87	13.69	23	28555	2258	110558463
Post procedural hypotension	60.91	13.69	12	28566	95	110560626
Anal incontinence	60.19	13.69	48	28530	21916	110538805
Therapeutic product effect prolonged	59.99	13.69	17	28561	701	110560020
Areflexia	59.88	13.69	31	28547	6738	110553983
Anaemia	59.13	13.69	34	28544	547052	110013669
Spinal anaesthesia	59.05	13.69	12	28566	113	110560608
Horner's syndrome	58.51	13.69	10	28568	31	110560690
Rash	58.46	13.69	76	28502	820888	109739833
Bradycardia foetal	58.04	13.69	12	28566	124	110560597
Purtscher retinopathy	56.83	13.69	13	28565	222	110560499
Procedural pain	56.25	13.69	57	28521	35508	110525213
Rheumatoid arthritis	56.17	13.69	6	28572	299607	110261114
Live birth	56.06	13.69	79	28499	69405	110491316
Neuromuscular blockade	54.94	13.69	16	28562	728	110559993
Ventricular tachycardia	54.60	13.69	66	28512	49943	110510778
Sinus arrest	54.28	13.69	25	28553	4217	110556504
Arthrofibrosis	54.28	13.69	11	28567	102	110560619
Monoplegia	53.81	13.69	26	28552	4883	110555838
Myopathy toxic	53.67	13.69	18	28560	1307	110559414
Complication associated with device	53.16	13.69	43	28535	20030	110540691
Spinal cord oedema	52.35	13.69	14	28564	464	110560257
Circulatory collapse	52.34	13.69	60	28518	42933	110517788
Cough	52.33	13.69	27	28551	461614	110099107
Blood pressure decreased	52.31	13.69	101	28477	114990	110445731
Haemodynamic instability	52.26	13.69	45	28533	22843	110537878
Mental status changes	51.97	13.69	80	28498	76042	110484679
Overdose	51.61	13.69	155	28423	233639	110327082
Hypoxia	50.92	13.69	107	28471	129408	110431313
Urinary retention	50.07	13.69	75	28503	69608	110491113
Vascular resistance systemic decreased	50.02	13.69	12	28566	254	110560467
Uterine atony	49.75	13.69	12	28566	260	110560461
Depressed level of consciousness	49.17	13.69	97	28481	112181	110448540
Strabismus	49.13	13.69	22	28556	3477	110557244
Bezold-Jarisch reflex	48.14	13.69	9	28569	52	110560669
Urinary incontinence	48.02	13.69	61	28517	48526	110512195
Platelet aggregation inhibition	47.49	13.69	11	28567	199	110560522
Parophthalmia	46.18	13.69	13	28565	523	110560198
Arachnoid web	45.98	13.69	7	28571	7	110560714
Spinal cord compression	45.90	13.69	27	28551	7525	110553196
Anaesthetic complication neurological	45.70	13.69	15	28563	1018	110559703
Ophthalmoplegia	45.67	13.69	21	28557	3529	110557192
Hypercapnia	45.52	13.69	31	28547	11128	110549593
Pulseless electrical activity	44.59	13.69	36	28542	16721	110544000
Product dose omission issue	44.30	13.69	14	28564	321768	110238953
Chondromalacia	44.09	13.69	10	28568	164	110560557
Motor dysfunction	43.96	13.69	42	28536	24364	110536357
Therapeutic product effect delayed	43.95	13.69	22	28556	4457	110556264
Postpartum haemorrhage	43.85	13.69	17	28561	1872	110558849
Product administration error	43.73	13.69	51	28527	37166	110523555
Death	43.52	13.69	71	28507	698798	109861923
Hypertensive encephalopathy	43.36	13.69	15	28563	1196	110559525
Sensory disturbance	43.35	13.69	36	28542	17393	110543328
Spinal shock	43.28	13.69	8	28570	43	110560678
Tachycardia	42.45	13.69	142	28436	226503	110334218
Allodynia	42.24	13.69	17	28561	2066	110558655
Implant site pain	41.23	13.69	17	28561	2198	110558523
Respiratory arrest	40.82	13.69	62	28516	58237	110502484
Exophthalmos	40.80	13.69	17	28561	2256	110558465
Device malfunction	40.48	13.69	41	28537	25517	110535204
Completed suicide	40.35	13.69	7	28571	242374	110318347
Myelitis transverse	39.90	13.69	17	28561	2384	110558337
Conjunctival oedema	39.69	13.69	15	28563	1541	110559180
Pyrexia	39.49	13.69	111	28467	898154	109662567
Neuromuscular block prolonged	39.13	13.69	14	28564	1233	110559488
Autonomic nervous system imbalance	38.68	13.69	22	28556	5758	110554963
Inspiratory capacity decreased	38.63	13.69	17	28561	2578	110558143
Cancer pain	38.00	13.69	23	28555	6749	110553972
Sinus tachycardia	38	13.69	52	28526	44441	110516280
Thrombocytopenia	37.21	13.69	22	28556	348863	110211858
Mental status changes postoperative	37.10	13.69	9	28569	200	110560521
Peripheral swelling	37.09	13.69	30	28548	404004	110156717
Systemic toxicity	36.81	13.69	10	28568	352	110560369
Paresis	36.68	13.69	20	28558	4824	110555897
Therapy non-responder	36.32	13.69	106	28472	157201	110403520
Phrenic nerve paralysis	36.28	13.69	11	28567	576	110560145
Sensorimotor disorder	36.18	13.69	13	28565	1159	110559562
Macular ischaemia	35.82	13.69	9	28569	232	110560489
Oculocardiac reflex	35.76	13.69	8	28570	123	110560598
White blood cell count decreased	35.30	13.69	8	28570	229382	110331339
Myelitis	35.16	13.69	17	28561	3196	110557525
Paraparesis	34.99	13.69	19	28559	4547	110556174
Neuralgia	34.57	13.69	52	28526	48426	110512295
Conus medullaris syndrome	34.06	13.69	7	28571	70	110560651
Trigeminal palsy	33.62	13.69	7	28571	75	110560646
COVID-19	33.12	13.69	11	28567	245049	110315672
Corneal reflex decreased	32.63	13.69	10	28568	543	110560178
Stridor	32.59	13.69	21	28557	6874	110553847
Peripartum cardiomyopathy	32.55	13.69	8	28570	188	110560533
Joint swelling	32.49	13.69	40	28538	442805	110117916
Diaphragmatic paralysis	31.30	13.69	12	28566	1282	110559439
Adverse drug reaction	31.27	13.69	78	28500	105481	110455240
Intracranial hypotension	31.22	13.69	10	28568	628	110560093
Disease progression	31.20	13.69	12	28566	244022	110316699
Malaise	31.01	13.69	81	28497	671738	109888983
Cardiotoxicity	30.31	13.69	29	28549	16852	110543869
Influenza	30.16	13.69	4	28574	169097	110391624
Blood pressure immeasurable	30.13	13.69	14	28564	2409	110558312
Systemic lupus erythematosus	30.12	13.69	14	28564	254324	110306397
Arteriospasm coronary	29.55	13.69	22	28556	9078	110551643
Uterine hypertonus	29.44	13.69	8	28570	282	110560439
Gastrointestinal haemorrhage	29.32	13.69	4	28574	165514	110395207
Somnolence	29.29	13.69	153	28425	297296	110263425
Nerve block	29.13	13.69	10	28568	779	110559942
Necrotising fasciitis	28.41	13.69	20	28558	7571	110553150
Arthritis bacterial	28.27	13.69	23	28555	10797	110549924
Renal impairment	28.15	13.69	7	28571	188438	110372283
Arthropathy	28.10	13.69	20	28558	287502	110273219
Brown-Sequard syndrome	28.05	13.69	6	28572	74	110560647
Infusion site mass	27.94	13.69	12	28566	1716	110559005
Medical device site erythema	27.83	13.69	6	28572	77	110560644
Manipulation	27.75	13.69	6	28572	78	110560643
Confusion postoperative	27.56	13.69	8	28570	360	110560361
Eclampsia	27.47	13.69	8	28570	364	110560357
Pulse absent	27.41	13.69	23	28555	11269	110549452
Hyponatraemia	27.33	13.69	11	28567	217642	110343079
Pain	27.31	13.69	371	28207	954584	109606137
Respiratory acidosis	27.22	13.69	25	28553	13801	110546920
Respiratory rate decreased	27.00	13.69	18	28560	6240	110554481
Blood creatinine increased	26.92	13.69	7	28571	182882	110377839
Rotator cuff syndrome	26.71	13.69	27	28551	16767	110543954
Dehydration	26.60	13.69	20	28558	279491	110281230
Catheter site granuloma	26.59	13.69	6	28572	96	110560625
Open globe injury	26.41	13.69	7	28571	224	110560497
Infusion related reaction	26.33	13.69	36	28542	381126	110179595
Therapeutic response prolonged	26.27	13.69	4	28574	4	110560717
Ventricular fibrillation	26.22	13.69	42	28536	41271	110519450
Respiratory distress	26.01	13.69	56	28522	68818	110491903
Weight decreased	26.00	13.69	51	28527	468006	110092715
Diplopia	25.78	13.69	42	28536	41852	110518869
Arthralgia	25.66	13.69	109	28469	779523	109781198
Amaurosis	25.58	13.69	11	28567	1578	110559143
Accidental overdose	25.41	13.69	47	28531	51787	110508934
Harlequin syndrome	25.30	13.69	7	28571	264	110560457
Uterine haemorrhage	25.28	13.69	14	28564	3480	110557241
Pemphigus	25.12	13.69	12	28566	214558	110346163
Anal sphincter atony	24.90	13.69	8	28570	507	110560214
Nasopharyngitis	24.57	13.69	40	28538	394321	110166400
Vocal cord paralysis	24.41	13.69	13	28565	2993	110557728
Spinal cord haematoma	24.28	13.69	7	28571	307	110560414
Peroneal nerve palsy	24.24	13.69	18	28560	7396	110553325
Device power source issue	23.86	13.69	10	28568	1347	110559374
Decreased appetite	23.80	13.69	55	28523	475791	110084930
Urinary tract infection	23.37	13.69	30	28548	326252	110234469
Brief psychotic disorder with marked stressors	23.34	13.69	7	28571	353	110560368
Seroma	23.27	13.69	13	28565	3288	110557433
Interstitial lung disease	23.23	13.69	4	28574	139330	110421391
Synovitis	23.15	13.69	22	28556	274070	110286651
Toxicity to various agents	23.07	13.69	207	28371	480348	110080373
Product closure issue	23.03	13.69	4	28574	14	110560707
Device kink	22.90	13.69	11	28567	2038	110558683
Withdrawal syndrome	22.86	13.69	34	28544	31346	110529375
Maternal use of illicit drugs	22.61	13.69	4	28574	16	110560705
Catheter site mass	22.59	13.69	5	28573	73	110560648
Cerebrospinal fluid leakage	22.41	13.69	11	28567	2137	110558584
Brugada syndrome	22.35	13.69	10	28568	1578	110559143
Unmasking of previously unidentified disease	22.16	13.69	12	28566	2856	110557865
Gastrointestinal disorder	22.15	13.69	18	28560	241934	110318787
Sciatic nerve palsy	22.10	13.69	5	28573	81	110560640
Product measured potency issue	21.99	13.69	6	28572	215	110560506
Cardiac failure congestive	21.81	13.69	6	28572	150994	110409727
Hypoglossal nerve disorder	21.78	13.69	3	28575	0	110560721
Femoral nerve palsy	21.77	13.69	5	28573	87	110560634
Medical device site swelling	21.66	13.69	5	28573	89	110560632
Quadriparesis	21.42	13.69	14	28564	4693	110556028
Abdominal pain upper	21.20	13.69	36	28542	349075	110211646
Nervous system disorder	21.17	13.69	33	28545	31688	110529033
Incision site pain	21.16	13.69	12	28566	3123	110557598
Lower respiratory tract infection	21.13	13.69	19	28559	243087	110317634
Drug intolerance	21.12	13.69	46	28532	406466	110154255
Premature baby	21.03	13.69	14	28564	4841	110555880
Hyperhidrosis	21.01	13.69	100	28478	187198	110373523
Bradyarrhythmia	20.82	13.69	14	28564	4920	110555801
Platelet dysfunction	20.82	13.69	7	28571	512	110560209
Wound	20.77	13.69	18	28560	234419	110326302
Fall	20.70	13.69	83	28495	603399	109957322
Symmetrical drug-related intertriginous and flexural exanthema	20.65	13.69	10	28568	1887	110558834
Quadriplegia	20.58	13.69	13	28565	4114	110556607
Pericarditis	20.43	13.69	16	28562	219098	110341623
Granuloma	20.34	13.69	18	28560	9472	110551249
Ventricular extrasystoles	20.15	13.69	27	28551	22614	110538107
Toxic anterior segment syndrome	20.08	13.69	12	28566	3442	110557279
Deafness bilateral	20.02	13.69	11	28567	2693	110558028
Extradural abscess	19.99	13.69	10	28568	2024	110558697
Pneumorrhachis	19.71	13.69	3	28575	3	110560718
Product quality issue	19.70	13.69	54	28524	77245	110483476
Implant site infection	19.67	13.69	10	28568	2093	110558628
Leukopenia	19.54	13.69	7	28571	148784	110411937
Electrocardiogram ST segment depression	19.54	13.69	14	28564	5447	110555274
Ventricular arrhythmia	19.39	13.69	18	28560	10069	110550652
Spherocytic anaemia	19.24	13.69	3	28575	4	110560717
Hiccups	19.21	13.69	20	28558	12849	110547872
Mydriasis	19.07	13.69	26	28552	22131	110538590
Maternal drugs affecting foetus	19.05	13.69	9	28569	1608	110559113
Muscle rigidity	18.90	13.69	27	28551	24004	110536717
Axillary nerve injury	18.65	13.69	4	28574	50	110560671
Product packaging confusion	18.64	13.69	6	28572	383	110560338
Corneal oedema	18.38	13.69	11	28567	3162	110557559
Tachyarrhythmia	18.37	13.69	16	28562	8245	110552476
Weight increased	18.28	13.69	52	28526	419592	110141129
Device alarm issue	18.25	13.69	10	28568	2436	110558285
Neurological procedural complication	18.17	13.69	3	28575	7	110560714
Medical device site discharge	18.03	13.69	4	28574	59	110560662
Device connection issue	17.85	13.69	8	28570	1266	110559455
Dose calculation error	17.84	13.69	6	28572	439	110560282
Hypoaesthesia oral	17.84	13.69	22	28556	16980	110543741
Abdominal discomfort	17.75	13.69	48	28530	393810	110166911
Oxygen saturation decreased	17.74	13.69	84	28494	156898	110403823
Wheezing	17.72	13.69	24	28554	255206	110305515
Psoriasis	17.69	13.69	7	28571	139986	110420735
General physical health deterioration	17.59	13.69	54	28524	425241	110135480
Alopecia	17.56	13.69	43	28535	364710	110196011
Intentional product use issue	17.53	13.69	23	28555	247883	110312838
Femoral nerve injury	17.45	13.69	4	28574	69	110560652
Fanconi syndrome	17.33	13.69	11	28567	3508	110557213
Injection site joint infection	17.13	13.69	4	28574	75	110560646
Radiculopathy	17.12	13.69	23	28555	19313	110541408
Myelopathy	17.04	13.69	13	28565	5563	110555158
Sepsis	17.04	13.69	37	28541	327309	110233412
Rhinorrhoea	17.00	13.69	3	28575	102663	110458058
Implant site swelling	17.00	13.69	6	28572	508	110560213
Paraesthesia	16.97	13.69	126	28452	276395	110284326
Spinal cord ischaemia	16.93	13.69	5	28573	239	110560482
Asthma	16.92	13.69	24	28554	250267	110310454
Hyperkalaemia	16.82	13.69	7	28571	135789	110424932
Neurogenic shock	16.81	13.69	7	28571	927	110559794
Oropharyngeal pain	16.71	13.69	7	28571	135269	110425452
Hospitalisation	16.62	13.69	8	28570	142485	110418236
Implant site scar	16.49	13.69	5	28573	262	110560459
Drug abuse	16.48	13.69	13	28565	177398	110383323
Spinal cord disorder	16.44	13.69	9	28569	2189	110558532
Implant site erythema	16.23	13.69	6	28572	580	110560141
Sphincter of Oddi dysfunction	16.21	13.69	6	28572	582	110560139
Urinary retention postoperative	16.20	13.69	5	28573	278	110560443
Intraocular pressure fluctuation	16.19	13.69	4	28574	96	110560625
Dural arteriovenous fistula	16.19	13.69	4	28574	96	110560625
Vasospasm	16.13	13.69	8	28570	1588	110559133
Dry skin	16.07	13.69	4	28574	107649	110453072
Iatrogenic injury	16.01	13.69	8	28570	1615	110559106
Nasal congestion	16.00	13.69	3	28575	98279	110462442
Cardiac output increased	15.98	13.69	6	28572	605	110560116
Stroke volume increased	15.81	13.69	3	28575	19	110560702
Administration site swelling	15.80	13.69	6	28572	625	110560096
Contraindicated product administered	15.62	13.69	25	28553	248242	110312479
Spinal epidural haematoma	15.55	13.69	8	28570	1717	110559004
Device computer issue	15.47	13.69	4	28574	116	110560605
Forceps delivery	15.41	13.69	4	28574	118	110560603
Myalgia	15.35	13.69	21	28557	222360	110338361
Procedural hypotension	15.34	13.69	9	28569	2496	110558225
Tinnitus	15.13	13.69	42	28536	60498	110500223
Brain injury	15.05	13.69	18	28560	13458	110547263
Renal failure	15.04	13.69	22	28556	226552	110334169
Tethered cord syndrome	14.98	13.69	3	28575	26	110560695
Medical device site infection	14.96	13.69	6	28572	723	110559998
Colitis	14.90	13.69	4	28574	102319	110458402
Extra dose administered	14.85	13.69	17	28561	12142	110548579
Heart rate increased	14.85	13.69	75	28503	143759	110416962
Nerve injury	14.84	13.69	16	28562	10697	110550024
Cardiac failure	14.77	13.69	16	28562	187610	110373111
Serotonin syndrome	14.75	13.69	41	28537	59112	110501609
Platelet count decreased	14.69	13.69	23	28555	230420	110330301
Staphylococcal abscess	14.65	13.69	7	28571	1282	110559439
Gastrooesophageal reflux disease	14.55	13.69	15	28563	179961	110380760
Pulmonary oedema	14.54	13.69	58	28520	100601	110460120
Anorectal disorder	14.53	13.69	9	28569	2750	110557971
Hyponatraemic encephalopathy	14.52	13.69	5	28573	393	110560328
Herpes zoster	14.40	13.69	5	28573	108374	110452347
Brain stem syndrome	14.40	13.69	7	28571	1332	110559389
Hypoglycaemia	14.36	13.69	6	28572	116098	110444623
Hypotonia	14.35	13.69	19	28559	15726	110544995
Subdural haematoma	14.18	13.69	30	28548	36424	110524297
Duodenal ulcer perforation	14.15	13.69	15	28563	177685	110383036
Meningitis aseptic	14.13	13.69	15	28563	9855	110550866
Device issue	14.11	13.69	29	28549	34506	110526215
Pre-eclampsia	13.92	13.69	14	28564	8636	110552085
Incision site rash	13.88	13.69	3	28575	39	110560682
Medication error	13.87	13.69	59	28519	105307	110455414
Neutrophil count decreased	13.79	13.69	7	28571	120934	110439787
Ocular retrobulbar haemorrhage	13.76	13.69	4	28574	181	110560540

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N01BB01	NERVOUS SYSTEM ANESTHETICS ANESTHETICS, LOCAL Amides
ATC	N01BB51	NERVOUS SYSTEM ANESTHETICS ANESTHETICS, LOCAL Amides
ATC	N01BB59	NERVOUS SYSTEM ANESTHETICS ANESTHETICS, LOCAL Amides
FDA CS	M0000897	Amides
CHEBI has role	CHEBI:35469	antidepressant
CHEBI has role	CHEBI:35480	analgesic
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:36333	local anaesthetic
CHEBI has role	CHEBI:37733	EC 3.1.1.8 (cholinesterase) inhibitor
CHEBI has role	CHEBI:37887	adrenergic antagonist
CHEBI has role	CHEBI:38070	anti-arrhythmia drug
CHEBI has role	CHEBI:51177	antitussive
CHEBI has role	CHEBI:53784	antispasmodic drug
CHEBI has role	CHEBI:55324	gastrointestinal drug
CHEBI has role	CHEBI:59941	amphiphile
CHEBI has role	CHEBI:60186	EC 3.6.3.8 (<em>Ca</em><small><sup>2+</small></sup>-transporting ATPase) inhibitor
CHEBI has role	CHEBI:64946	anti-HIV agent
CHEBI has role	CHEBI:67079	anti-inflammatory agent
CHEBI has role	CHEBI:73336	vulnerary
CHEBI has role	CHEBI:74518	anti-obesity agent
CHEBI has role	CHEBI:88188	drug allergen
MeSH PA	D000777	Anesthetics
MeSH PA	D000779	Anesthetics, Local
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D018689	Sensory System Agents
FDA EPC	N0000175682	Amide Local Anesthetic
FDA PE	N0000175976	Local Anesthesia
CHEBI has role	CHEBI:38867	anaesthetic

Related Drugs by ATC class:

N01BB Amides 10 drugs

articaine butanilicaine cinchocaine etidocaine levobupivacaine lidocaine meloxicam mepivacaine prilocaine ropivacaine

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Anesthesia for cesarean section	indication	4847005
Local anesthetic intrathecal block	indication	231249005
Skin irritation	indication	367466007
Local anesthesia	indication	386761002
Itching of skin	indication	418363000
Minor Skin Wound Pain	indication
Major Nerve Block for Surgery	indication
Regional Anesthesia for Surgery	indication
Regional Anesthesia for Labor Pain	indication
Regional Anesthesia for Ophthalmologic Surgery	indication
Regional Anesthesia for Postoperative Pain	indication
Local Anesthesia for Ophthalmologic Procedure	indication
Suicidal thoughts	contraindication	6471006
Dependent drug abuse	contraindication	6525002
Alcoholism	contraindication	7200002
Alcohol withdrawal delirium	contraindication	8635005
Sinus tachycardia	contraindication	11092001
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Asthenia	contraindication	13791008
Constipation	contraindication	14760008	DOID:2089
Chronic disease of respiratory system	contraindication	17097001
Mood swings	contraindication	18963009
Myocardial infarction	contraindication	22298006	DOID:5844
Inflammatory bowel disease	contraindication	24526004	DOID:0050589
Alcohol intoxication	contraindication	25702006
Complete atrioventricular block	contraindication	27885002
Shock	contraindication	27942005
Hypovolemia	contraindication	28560003
Hypercapnia	contraindication	29596007
Parkinsonism	contraindication	32798002
Dehydration	contraindication	34095006
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Hypothyroidism	contraindication	40930008	DOID:1459
Hypokalemia	contraindication	43339004
Decreased cardiac function	contraindication	43650005
Conduction disorder of the heart	contraindication	44808001
Low blood pressure	contraindication	45007003
Stokes-Adams syndrome	contraindication	46935006
Chronic heart failure	contraindication	48447003
Bradycardia	contraindication	48867003
Atrial fibrillation	contraindication	49436004	DOID:0060224
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Sinus bradycardia	contraindication	49710005
Bleeding hemorrhoids	contraindication	51551000
Paralytic ileus	contraindication	55525008	DOID:8442
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Ulcerative colitis	contraindication	64766004	DOID:8577
Cerebral arteriosclerosis	contraindication	65312002
Drug AND/OR toxin-induced diarrhea	contraindication	65979008
Substance abuse	contraindication	66214007
Benign intracranial hypertension	contraindication	68267002	DOID:11459
Diabetes mellitus	contraindication	73211009	DOID:9351
Wolff-Parkinson-White pattern	contraindication	74390002	DOID:384
Urethral stricture	contraindication	76618002
Decreased respiratory function	contraindication	80954004
Injury of head	contraindication	82271004
Cor pulmonale	contraindication	83291003	DOID:8515
Pulmonary emphysema	contraindication	87433001
Cardiogenic shock	contraindication	89138009
Kidney disease	contraindication	90708001	DOID:557
Myasthenia gravis	contraindication	91637004	DOID:437
Disorder of mucous membrane	contraindication	95351003
Disorder of biliary tract	contraindication	105997008	DOID:9741
Acute abdominal pain	contraindication	116290004
Procedure on urinary system	contraindication	118677009
Open wound	contraindication	125643001
Neoplasm of brain	contraindication	126952004	DOID:1319
Seizure disorder	contraindication	128613002
Bleeding	contraindication	131148009
Drug-induced psychosis	contraindication	191483003	DOID:1742
Angina pectoris	contraindication	194828000
Primary dilated cardiomyopathy	contraindication	195021004
Partial atrioventricular block	contraindication	195039008
Disease of liver	contraindication	235856003	DOID:409
Morbid obesity	contraindication	238136002	DOID:11981
Sepsis syndrome	contraindication	238150007
Benign prostatic hyperplasia	contraindication	266569009
Retention of urine	contraindication	267064002
Exacerbation of asthma	contraindication	281239006
Lesion of brain	contraindication	301766008
Deficiency of cholinesterase	contraindication	360607009
Coma	contraindication	371632003
Primary adrenocortical insufficiency	contraindication	373662000
Operation on gastrointestinal tract	contraindication	386621005
Hypoxia	contraindication	389086002
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Disorder of coronary artery	contraindication	414024009
Central nervous system depression	contraindication	418072004
Denuded skin	contraindication	418242004
Dysfunction of sphincter of Oddi	contraindication	430887001
Acute exacerbation of asthma	contraindication	708038006
Reduced Hepatic Blood Flow	contraindication
Lidocaine Toxicity	contraindication

🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Regional postoperative analgesia after onychocomy	Indication
Dogs	Local postoperative analgesia for cranial cruciate ligament surgery	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Nocita	Elanco US Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.24	acidic
pKa2	7.92	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG	XARACOLL	INNOCOLL PHARMS	N209511	Aug. 28, 2020	DISCN	IMPLANT	IMPLANTATION	RE47826	May 20, 2029	A METHOD FOR INDUCING A POST-SURGICAL ANALGESIA SPARING EFFECT BY IMPLANTING AT THE SURGICAL SITE A COLLAGEN SPONGE CONTAINING BUPIVACAINE HCL WHICH PROVIDES LOCAL ANESTHESIA FOR UP TO 24 HOURS FOLLOWING IMPLANTATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11253504	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9592227	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9913909	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11253504	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9592227	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9913909	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11253504	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9592227	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9913909	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11253504	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9592227	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9913909	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10098957	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10213510	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10632199	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10898575	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11083730	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11083797	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11413350	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9694079	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9801945	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10098957	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10213510	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10632199	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10898575	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11083730	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11083797	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11413350	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9694079	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9801945	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10098957	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10213510	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10632199	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10898575	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11083730	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11083797	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11413350	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9694079	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9801945	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10098957	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10213510	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10632199	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10898575	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11083730	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11083797	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11413350	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9694079	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9801945	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11844837	April 21, 2036	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11844837	April 21, 2036	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11844837	April 21, 2036	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11844837	April 21, 2036	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
660MG/5ML (132MG/ML)	POSIMIR	INNOCOLL	N204803	Feb. 1, 2021	DISCN	SOLUTION	INFILTRATION	11771624	Jan. 12, 2041	TO PRODUCE POST-SURGICAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11033495	Jan. 22, 2041	METHOD OF PROVIDING POSTSURGICAL PAIN MANAGEMENT, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11179336	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11278494	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11304904	Jan. 22, 2041	METHOD OF PROVIDING LOCAL OR REGIONAL ANALGESIA VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK OR FEMORAL NERVE BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11311486	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11357727	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11426348	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11452691	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA NERVE BLOCK, FOR EXAMPLE, NTERSCALENE BRACHIAL PLEXUS FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11819574	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11819575	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11925706	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12144890	Jan. 22, 2041	METHOD OF PROVIDING LOCAL OR REGIONAL ANALGESIA, FOR EXAMPLE, VIA INFILTRATION TO PROVIDE POSTSURGICAL LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK TO PROVIDE POSTSURGICAL REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12151024	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION TO PROVIDE LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK TO PROVIDE REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12296047	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION TO PROVIDE LOCAL ANALGESIA OR VIA A NERVE BLOCK TO PROVIDE REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11033495	Jan. 22, 2041	METHOD OF PROVIDING POSTSURGICAL PAIN MANAGEMENT, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11179336	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11278494	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11304904	Jan. 22, 2041	METHOD OF PROVIDING LOCAL OR REGIONAL ANALGESIA VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK OR FEMORAL NERVE BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11311486	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11357727	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11426348	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11452691	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA NERVE BLOCK, FOR EXAMPLE, NTERSCALENE BRACHIAL PLEXUS FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11819574	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11819575	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11925706	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12144890	Jan. 22, 2041	METHOD OF PROVIDING LOCAL OR REGIONAL ANALGESIA, FOR EXAMPLE, VIA INFILTRATION TO PROVIDE POSTSURGICAL LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK TO PROVIDE POSTSURGICAL REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12151024	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION TO PROVIDE LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK TO PROVIDE REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12296047	Jan. 22, 2041	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION TO PROVIDE LOCAL ANALGESIA OR VIA A NERVE BLOCK TO PROVIDE REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11931459	March 17, 2042	A METHOD OF TREATING PAIN BY ADMINISTERING BUPIVACAINE VIA LOCAL INFILTRATION IN PEDIATRIC PATIENTS AGED 6 TO LESS THAN 12 YEARS OLD UNDERGOING CARDIAC SURGERY
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11931459	March 17, 2042	A METHOD OF TREATING PAIN BY ADMINISTERING BUPIVACAINE VIA LOCAL INFILTRATION IN PEDIATRIC PATIENTS AGED 6 TO LESS THAN 17 YEARS OLD UNDERGOING SPINE SURGERY
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11931459	March 17, 2042	A METHOD OF TREATING PAIN BY ADMINISTERING BUPIVACAINE VIA LOCAL INFILTRATION IN PEDIATRIC PATIENTS AGED 6 TO LESS THAN 12 YEARS OLD UNDERGOING CARDIAC SURGERY
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11931459	March 17, 2042	A METHOD OF TREATING PAIN BY ADMINISTERING BUPIVACAINE VIA LOCAL INFILTRATION IN PEDIATRIC PATIENTS AGED 6 TO LESS THAN 17 YEARS OLD UNDERGOING SPINE SURGERY
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11918565	Feb. 2, 2043	A METHOD OF ADMINISTERING BUPIVACAINE TO PRODUCE REGIONAL ANALGESIA VIA SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA IN ADULTS
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12226610	Feb. 2, 2043	METHOD OF ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA VIA AN ADDUCTOR CANAL BLOCK IN ADULTS
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12226610	Feb. 2, 2043	METHOD OF INCREASING THE AMOUNT OF TIME BEFORE POSTSURGICAL OPIOID MEDICATION IS ADMINISTERED TO A PATIENT BY ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12226610	Feb. 2, 2043	METHOD OF REDUCING POSTSURGICAL OPIOID CONSUMPTION BY ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	11918565	Feb. 2, 2043	A METHOD OF ADMINISTERING BUPIVACAINE TO PRODUCE REGIONAL ANALGESIA VIA SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA IN ADULTS
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12226610	Feb. 2, 2043	METHOD OF ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA VIA AN ADDUCTOR CANAL BLOCK IN ADULTS
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12226610	Feb. 2, 2043	METHOD OF INCREASING THE AMOUNT OF TIME BEFORE POSTSURGICAL OPIOID MEDICATION IS ADMINISTERED TO A PATIENT BY ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12226610	Feb. 2, 2043	METHOD OF REDUCING POSTSURGICAL OPIOID CONSUMPTION BY ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12251468	July 2, 2044	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA; OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK, SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA, OR ADDUCTOR CANAL BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12318483	July 2, 2044	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA; OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK, SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA, OR ADDUCTOR CANAL BLOCK FOR REGIONAL ANALGESIA
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12370142	July 2, 2044	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA; OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK, SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA, OR ADDUCTOR CANAL BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12251468	July 2, 2044	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA; OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK, SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA, OR ADDUCTOR CANAL BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12318483	July 2, 2044	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA; OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK, SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA, OR ADDUCTOR CANAL BLOCK FOR REGIONAL ANALGESIA
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	12370142	July 2, 2044	METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA; OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK, SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA, OR ADDUCTOR CANAL BLOCK FOR REGIONAL ANALGESIA

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
133MG/10ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	Nov. 9, 2026	INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA A SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK
266MG/20ML (13.3MG/ML)	EXPAREL	PACIRA PHARMS INC	N022496	Oct. 28, 2011	RX	INJECTABLE, LIPOSOMAL	INJECTION	Nov. 9, 2026	INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA A SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	Jan. 23, 2027	REVISIONS TO THE LABELING TO EXPAND THE USE IN CERTAIN SOFT TISSUE AND CERTAIN ORTHOPEDIC SURGICAL PROCEDURES AS WELL AS REVISING THE LIMITATIONS OF USE
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	Jan. 23, 2027	REVISIONS TO THE LABELING TO EXPAND THE USE IN CERTAIN SOFT TISSUE AND CERTAIN ORTHOPEDIC SURGICAL PROCEDURES AS WELL AS REVISING THE LIMITATIONS OF USE
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	Jan. 23, 2027	REVISIONS TO THE LABELING TO EXPAND THE USE IN CERTAIN SOFT TISSUE AND CERTAIN ORTHOPEDIC SURGICAL PROCEDURES AS WELL AS REVISING THE LIMITATIONS OF USE
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	Jan. 23, 2027	REVISIONS TO THE LABELING TO EXPAND THE USE IN CERTAIN SOFT TISSUE AND CERTAIN ORTHOPEDIC SURGICAL PROCEDURES AS WELL AS REVISING THE LIMITATIONS OF USE

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium channel protein type 4 subunit alpha	Ion channel	P35499	SCN4A_HUMAN	BLOCKER	IC50	6	WOMBAT-PK	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	4.66	CHEMBL
Sodium channel protein type 1 subunit alpha	Ion channel	P35498	SCN1A_HUMAN		IC50	5.29	WOMBAT-PK
Prostaglandin E2 receptor EP1 subtype	GPCR	P34995	PE2R1_HUMAN		IC50	5.51	WOMBAT-PK
Cytochrome P450 2D6	Enzyme	P10635	CP2D6_HUMAN		IC50	6.40	DRUG MATRIX
5-hydroxytryptamine receptor 3A	Ion channel	P46098	5HT3A_HUMAN		IC50	4.23	WOMBAT-PK
Potassium voltage-gated channel subfamily D member 3	Ion channel	Q9UK17	KCND3_HUMAN		IC50	4.50	WOMBAT-PK
Potassium voltage-gated channel subfamily A member 5	Ion channel	P22460	KCNA5_HUMAN	BLOCKER	Kd	5.40	IUPHAR
Potassium channel subfamily K member 3	Ion channel	O14649	KCNK3_HUMAN		IC50	4.39	CHEMBL
Sodium channel protein type 5 subunit alpha	Ion channel	Q14524	SCN5A_HUMAN	BLOCKER	IC50	5.66	IUPHAR
Potassium voltage-gated channel subfamily D member 3	Ion channel		KCND3_MOUSE	BLOCKER	IC50	4.50	IUPHAR
Potassium channel subfamily K member 3	Ion channel		KCNK3_RAT		IC50	4.39	CHEMBL
Potassium channel subfamily K member 9	Ion channel		KCNK9_RAT		IC50	4	CHEMBL

External reference:

ID	Source
4019643	VUID
N0000147736	NUI
D07552	KEGG_DRUG
18010-40-7	SECONDARY_CAS_RN
73360-54-0	SECONDARY_CAS_RN
1375412	RXNORM
C0006400	UMLSCUI
CHEBI:3215	CHEBI
CHEMBL1098	ChEMBL_ID
CHEMBL1200396	ChEMBL_ID
DB00297	DRUGBANK_ID
D002045	MESH_DESCRIPTOR_UI
2474	PUBCHEM_CID
2397	IUPHAR_LIGAND_ID
C472824	MESH_SUPPLEMENTAL_RECORD_UI
2279	INN_ID
Y8335394RO	UNII
3621	MMSL
39700	MMSL
4305	MMSL
d00180	MMSL
1268954003	SNOMEDCT_US
24022008	SNOMEDCT_US
27196008	SNOMEDCT_US
387150008	SNOMEDCT_US
4018244	VANDF
4019643	VANDF
001341	NDDF
005054	NDDF
Y8335394RO	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9328	INJECTION, SOLUTION	2.50 mg	INFILTRATION	ANDA	25 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9329	INJECTION, SOLUTION	5 mg	PERINEURAL	ANDA	25 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9330	INJECTION, SOLUTION	2.50 mg	EPIDURAL	ANDA	24 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9331	INJECTION, SOLUTION	5 mg	EPIDURAL	ANDA	24 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9332	INJECTION, SOLUTION	7.50 mg	EPIDURAL	ANDA	24 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9333	INJECTION, SOLUTION	2.50 mg	EPIDURAL	ANDA	24 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9334	INJECTION, SOLUTION	5 mg	EPIDURAL	ANDA	24 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9335	INJECTION, SOLUTION	7.50 mg	EPIDURAL	ANDA	24 sections
Bupivacaine Hydrochloride with Dextrose	HUMAN PRESCRIPTION DRUG LABEL	1	0264-9379	INJECTION	7.50 mg	SUBARACHNOID	ANDA	24 sections
Marcaine	HUMAN PRESCRIPTION DRUG LABEL	2	0362-0557	INJECTION, SOLUTION	5 mg	SUBMUCOSAL	ANDA	19 sections
Marcaine	HUMAN PRESCRIPTION DRUG LABEL	2	0362-0557	INJECTION, SOLUTION	5 mg	SUBMUCOSAL	ANDA	19 sections
Vivacaine	HUMAN PRESCRIPTION DRUG LABEL	2	0362-9011	INJECTION, SOLUTION	5 mg	SUBMUCOSAL	ANDA	19 sections
Marcaine	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9768	INJECTION, SOLUTION	5 mg	EPIDURAL	NDA	16 sections
Marcaine	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9770	INJECTION, SOLUTION	2.50 mg	EPIDURAL	NDA	17 sections
Marcaine	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9779	INJECTION, SOLUTION	5 mg	EPIDURAL	NDA	16 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9826	INJECTION, SOLUTION	2.50 mg	INFILTRATION	ANDA	17 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9826	INJECTION, SOLUTION	2.50 mg	INFILTRATION	ANDA	17 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9827	INJECTION, SOLUTION	5 mg	PERINEURAL	ANDA	17 sections
Bupivacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9827	INJECTION, SOLUTION	5 mg	PERINEURAL	ANDA	17 sections
Bupivacaine Hydrochloride and Epinephrine	HUMAN PRESCRIPTION DRUG LABEL	2	0404-9828	INJECTION, SOLUTION	2.50 mg	INFILTRATION	ANDA	12 sections
Bupivacaine Hydrochloride and Epinephrine	HUMAN PRESCRIPTION DRUG LABEL	2	0404-9828	INJECTION, SOLUTION	2.50 mg	INFILTRATION	ANDA	12 sections
Marcaine	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9907	INJECTION, SOLUTION	5 mg	EPIDURAL	NDA	17 sections
MARCAINE WITH EPINEPHRINE	HUMAN PRESCRIPTION DRUG LABEL	2	0404-9908	INJECTION, SOLUTION	2.50 mg	INFILTRATION	NDA	17 sections
Sensorcaine	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9945	INJECTION, SOLUTION	2.50 mg	INFILTRATION	NDA	17 sections
Sensorcaine	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9945	INJECTION, SOLUTION	2.50 mg	INFILTRATION	NDA	17 sections
Sensorcaine MPF	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9946	INJECTION, SOLUTION	5 mg	PERINEURAL	ANDA	16 sections
Sensorcaine MPF	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9946	INJECTION, SOLUTION	5 mg	PERINEURAL	ANDA	16 sections
Sensorcaine	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9947	INJECTION, SOLUTION	5 mg	PERINEURAL	NDA	11 sections
Sensorcaine	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9947	INJECTION, SOLUTION	5 mg	PERINEURAL	NDA	11 sections
Marcaine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0525	INJECTION, SOLUTION	250 mg	PERINEURAL	NDA	28 sections

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bupivacaine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

Drug Use | Suggest Off label Use Form| |View source of the data|

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: