bupivacaine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| local anaesthetics | 432 | 38396-39-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A widely used local anesthetic agent.
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 |
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 | 1566.71 | 16.99 | 294 | 16872 | 1666 | 63470190 |
| Maternal exposure during delivery | 690.87 | 16.99 | 142 | 17024 | 1358 | 63470498 |
| Exposure during pregnancy | 602.09 | 16.99 | 424 | 16742 | 155123 | 63316733 |
| Hypotension | 404.05 | 16.99 | 429 | 16737 | 272175 | 63199681 |
| Drug ineffective | 398.00 | 16.99 | 867 | 16299 | 1043898 | 62427958 |
| Maternal exposure during pregnancy | 346.57 | 16.99 | 358 | 16808 | 219704 | 63252152 |
| Chondrolysis | 291.99 | 16.99 | 51 | 17115 | 176 | 63471680 |
| Local anaesthetic systemic toxicity | 281.93 | 16.99 | 62 | 17104 | 837 | 63471019 |
| Cauda equina syndrome | 216.47 | 16.99 | 51 | 17115 | 951 | 63470905 |
| Bradycardia | 205.27 | 16.99 | 165 | 17001 | 73062 | 63398794 |
| Incorrect route of product administration | 165.14 | 16.99 | 99 | 17067 | 27353 | 63444503 |
| Normal newborn | 159.22 | 16.99 | 66 | 17100 | 8275 | 63463581 |
| Premature delivery | 146.28 | 16.99 | 95 | 17071 | 30186 | 63441670 |
| Drug withdrawal syndrome | 140.48 | 16.99 | 89 | 17077 | 27105 | 63444751 |
| Procedural hypotension | 120.16 | 16.99 | 33 | 17133 | 1157 | 63470699 |
| Paralysis | 117.04 | 16.99 | 56 | 17110 | 9844 | 63462012 |
| Wrong product administered | 115.20 | 16.99 | 48 | 17118 | 6093 | 63465763 |
| Unresponsive to stimuli | 113.83 | 16.99 | 85 | 17081 | 33731 | 63438125 |
| Respiratory depression | 113.62 | 16.99 | 61 | 17105 | 13654 | 63458202 |
| Implant site extravasation | 110.95 | 16.99 | 26 | 17140 | 473 | 63471383 |
| Anterior spinal artery syndrome | 107.71 | 16.99 | 20 | 17146 | 105 | 63471751 |
| Extradural haematoma | 103.86 | 16.99 | 32 | 17134 | 1690 | 63470166 |
| Diarrhoea | 97.62 | 16.99 | 36 | 17130 | 715330 | 62756526 |
| Cardiac arrest | 93.41 | 16.99 | 120 | 17046 | 92425 | 63379431 |
| Hypoaesthesia | 93.40 | 16.99 | 165 | 17001 | 168228 | 63303628 |
| Lagophthalmos | 91.39 | 16.99 | 21 | 17145 | 349 | 63471507 |
| Caesarean section | 91.09 | 16.99 | 57 | 17109 | 16975 | 63454881 |
| Ventilation perfusion mismatch | 89.40 | 16.99 | 22 | 17144 | 496 | 63471360 |
| Inadequate analgesia | 87.04 | 16.99 | 32 | 17134 | 2911 | 63468945 |
| Spinal cord injury | 86.64 | 16.99 | 24 | 17142 | 869 | 63470987 |
| Myoclonus | 84.60 | 16.99 | 53 | 17113 | 15815 | 63456041 |
| Fatigue | 82.22 | 16.99 | 72 | 17094 | 887956 | 62583900 |
| Rhythm idioventricular | 81.49 | 16.99 | 18 | 17148 | 248 | 63471608 |
| Live birth | 80.88 | 16.99 | 62 | 17104 | 25568 | 63446288 |
| Arachnoiditis | 76.98 | 16.99 | 18 | 17148 | 324 | 63471532 |
| Paraplegia | 75.15 | 16.99 | 28 | 17138 | 2644 | 63469212 |
| Hyperaesthesia | 72.99 | 16.99 | 40 | 17126 | 9318 | 63462538 |
| Generalised tonic-clonic seizure | 72.04 | 16.99 | 61 | 17105 | 28955 | 63442901 |
| Apnoea | 70.16 | 16.99 | 37 | 17129 | 7985 | 63463871 |
| Medical device site pain | 70.13 | 16.99 | 15 | 17151 | 176 | 63471680 |
| Purtscher retinopathy | 67.58 | 16.99 | 13 | 17153 | 85 | 63471771 |
| Anaphylactic shock | 65.58 | 16.99 | 53 | 17113 | 23580 | 63448276 |
| Sedation | 62.30 | 16.99 | 64 | 17102 | 38745 | 63433111 |
| Foetal exposure during delivery | 60.90 | 16.99 | 13 | 17153 | 151 | 63471705 |
| Hypoxia | 59.46 | 16.99 | 77 | 17089 | 59715 | 63412141 |
| Hypothermia | 59.24 | 16.99 | 40 | 17126 | 13541 | 63458315 |
| Sensory loss | 59.15 | 16.99 | 36 | 17130 | 10202 | 63461654 |
| Anaphylactic reaction | 57.89 | 16.99 | 80 | 17086 | 66020 | 63405836 |
| Rash | 57.38 | 16.99 | 41 | 17125 | 560830 | 62911026 |
| Parophthalmia | 57.17 | 16.99 | 14 | 17152 | 309 | 63471547 |
| Spinal anaesthesia | 56.49 | 16.99 | 10 | 17156 | 38 | 63471818 |
| Premature baby | 56.47 | 16.99 | 46 | 17120 | 20689 | 63451167 |
| Procedural complication | 55.99 | 16.99 | 28 | 17138 | 5411 | 63466445 |
| Post procedural complication | 55.40 | 16.99 | 42 | 17124 | 17032 | 63454824 |
| Meningitis chemical | 55.26 | 16.99 | 12 | 17154 | 152 | 63471704 |
| Conjunctival oedema | 55.15 | 16.99 | 16 | 17150 | 686 | 63471170 |
| Labelled drug-drug interaction medication error | 54.97 | 16.99 | 38 | 17128 | 13361 | 63458495 |
| Delayed recovery from anaesthesia | 53.67 | 16.99 | 16 | 17150 | 755 | 63471101 |
| Rheumatoid arthritis | 53.38 | 16.99 | 4 | 17162 | 253815 | 63218041 |
| Bradycardia foetal | 53.00 | 16.99 | 14 | 17152 | 422 | 63471434 |
| Blood pressure decreased | 52.94 | 16.99 | 76 | 17090 | 64946 | 63406910 |
| Seizure | 52.73 | 16.99 | 113 | 17053 | 132521 | 63339335 |
| Post lumbar puncture syndrome | 52.68 | 16.99 | 15 | 17151 | 601 | 63471255 |
| Hypertensive encephalopathy | 52.16 | 16.99 | 15 | 17151 | 623 | 63471233 |
| Platelet aggregation inhibition | 51.28 | 16.99 | 11 | 17155 | 131 | 63471725 |
| Therapeutic product effect prolonged | 50.77 | 16.99 | 13 | 17153 | 346 | 63471510 |
| Urinary retention | 50.50 | 16.99 | 51 | 17115 | 30250 | 63441606 |
| Spinal cord infarction | 49.57 | 16.99 | 12 | 17154 | 252 | 63471604 |
| Therapeutic product effect delayed | 49.30 | 16.99 | 20 | 17146 | 2371 | 63469485 |
| Vascular resistance systemic decreased | 48.96 | 16.99 | 10 | 17156 | 92 | 63471764 |
| Circulatory collapse | 48.15 | 16.99 | 43 | 17123 | 21895 | 63449961 |
| Overdose | 48.00 | 16.99 | 100 | 17066 | 114978 | 63356878 |
| Horner's syndrome | 47.43 | 16.99 | 8 | 17158 | 21 | 63471835 |
| Postpartum haemorrhage | 45.81 | 16.99 | 18 | 17148 | 1963 | 63469893 |
| Arachnoid web | 45.66 | 16.99 | 7 | 17159 | 7 | 63471849 |
| Neurotoxicity | 44.82 | 16.99 | 37 | 17129 | 16953 | 63454903 |
| Haemodynamic instability | 44.76 | 16.99 | 29 | 17137 | 9161 | 63462695 |
| Loss of consciousness | 43.94 | 16.99 | 98 | 17068 | 118023 | 63353833 |
| Diplegia | 43.89 | 16.99 | 15 | 17151 | 1102 | 63470754 |
| No adverse event | 43.80 | 16.99 | 55 | 17111 | 41350 | 63430506 |
| Nasopharyngitis | 43.65 | 16.99 | 8 | 17158 | 254249 | 63217607 |
| Neuromuscular blockade | 43.17 | 16.99 | 11 | 17155 | 287 | 63471569 |
| Intracranial hypotension | 42.95 | 16.99 | 11 | 17155 | 293 | 63471563 |
| Motor dysfunction | 42.93 | 16.99 | 30 | 17136 | 10731 | 63461125 |
| Mental status changes postoperative | 42.26 | 16.99 | 10 | 17156 | 190 | 63471666 |
| Pneumonia | 42.12 | 16.99 | 37 | 17129 | 456730 | 63015126 |
| Joint swelling | 42.05 | 16.99 | 18 | 17148 | 327648 | 63144208 |
| Pulseless electrical activity | 39.78 | 16.99 | 25 | 17141 | 7496 | 63464360 |
| Spinal cord oedema | 39.49 | 16.99 | 9 | 17157 | 144 | 63471712 |
| Exophthalmos | 39.42 | 16.99 | 15 | 17151 | 1501 | 63470355 |
| Procedural pain | 39.08 | 16.99 | 38 | 17128 | 21531 | 63450325 |
| Pyrexia | 38.88 | 16.99 | 42 | 17124 | 470436 | 63001420 |
| Peripheral swelling | 38.52 | 16.99 | 12 | 17154 | 265930 | 63205926 |
| Prescribed overdose | 37.14 | 16.99 | 46 | 17120 | 34107 | 63437749 |
| Harlequin syndrome | 37.05 | 16.99 | 7 | 17159 | 41 | 63471815 |
| Uterine atony | 36.91 | 16.99 | 9 | 17157 | 195 | 63471661 |
| Therapy non-responder | 36.48 | 16.99 | 70 | 17096 | 75831 | 63396025 |
| Depressed level of consciousness | 35.86 | 16.99 | 62 | 17104 | 62016 | 63409840 |
| Ventricular tachycardia | 35.83 | 16.99 | 35 | 17131 | 19944 | 63451912 |
| Product quality issue | 35.35 | 16.99 | 46 | 17120 | 35819 | 63436037 |
| Necrotising fasciitis | 35.32 | 16.99 | 17 | 17149 | 3024 | 63468832 |
| Product dose omission issue | 34.98 | 16.99 | 10 | 17156 | 234303 | 63237553 |
| Peripartum cardiomyopathy | 34.06 | 16.99 | 8 | 17158 | 147 | 63471709 |
| Spinal cord compression | 33.09 | 16.99 | 18 | 17148 | 4130 | 63467726 |
| Acute kidney injury | 32.95 | 16.99 | 15 | 17151 | 263400 | 63208456 |
| Systemic lupus erythematosus | 32.92 | 16.99 | 8 | 17158 | 208910 | 63262946 |
| Respiratory rate decreased | 32.90 | 16.99 | 17 | 17149 | 3518 | 63468338 |
| Complication associated with device | 32.82 | 16.99 | 31 | 17135 | 16947 | 63454909 |
| Ophthalmoplegia | 32.79 | 16.99 | 13 | 17153 | 1451 | 63470405 |
| Neuromuscular block prolonged | 32.38 | 16.99 | 10 | 17156 | 532 | 63471324 |
| Tachycardia | 32.20 | 16.99 | 87 | 17079 | 118069 | 63353787 |
| Strabismus | 32.01 | 16.99 | 14 | 17152 | 2000 | 63469856 |
| Cerebrospinal fluid leakage | 31.75 | 16.99 | 12 | 17154 | 1178 | 63470678 |
| Neuralgia | 31.59 | 16.99 | 37 | 17129 | 25889 | 63445967 |
| Neutropenia | 31.13 | 16.99 | 5 | 17161 | 175000 | 63296856 |
| Weight increased | 30.87 | 16.99 | 16 | 17150 | 260776 | 63211080 |
| Kounis syndrome | 30.69 | 16.99 | 13 | 17153 | 1717 | 63470139 |
| Confusion postoperative | 30.39 | 16.99 | 8 | 17158 | 238 | 63471618 |
| Cough | 30.39 | 16.99 | 21 | 17145 | 292722 | 63179134 |
| Death | 30.26 | 16.99 | 34 | 17132 | 374347 | 63097509 |
| Arthropathy | 29.94 | 16.99 | 13 | 17153 | 234779 | 63237077 |
| Muscular weakness | 29.33 | 16.99 | 86 | 17080 | 122267 | 63349589 |
| Respiratory arrest | 29.30 | 16.99 | 40 | 17126 | 32605 | 63439251 |
| Sensorimotor disorder | 29.17 | 16.99 | 9 | 17157 | 477 | 63471379 |
| Uterine hypertonus | 28.81 | 16.99 | 8 | 17158 | 292 | 63471564 |
| Anaesthetic complication cardiac | 28.68 | 16.99 | 5 | 17161 | 17 | 63471839 |
| Monoplegia | 28.66 | 16.99 | 15 | 17151 | 3186 | 63468670 |
| Device infusion issue | 28.65 | 16.99 | 13 | 17153 | 2025 | 63469831 |
| Arteriospasm coronary | 28.32 | 16.99 | 16 | 17150 | 3952 | 63467904 |
| Product formulation issue | 27.64 | 16.99 | 9 | 17157 | 569 | 63471287 |
| Myelitis transverse | 27.57 | 16.99 | 11 | 17155 | 1249 | 63470607 |
| Medical device site erythema | 27.47 | 16.99 | 5 | 17161 | 23 | 63471833 |
| Urinary tract infection | 27.45 | 16.99 | 19 | 17147 | 264665 | 63207191 |
| Weight decreased | 27.24 | 16.99 | 21 | 17145 | 276777 | 63195079 |
| Fall | 27.19 | 16.99 | 40 | 17126 | 392294 | 63079562 |
| Pemphigus | 27.12 | 16.99 | 8 | 17158 | 183718 | 63288138 |
| Bundle branch block left | 26.58 | 16.99 | 19 | 17147 | 7040 | 63464816 |
| Low birth weight baby | 26.41 | 16.99 | 19 | 17147 | 7110 | 63464746 |
| Implant site infection | 26.24 | 16.99 | 10 | 17156 | 1004 | 63470852 |
| Product measured potency issue | 25.61 | 16.99 | 6 | 17160 | 109 | 63471747 |
| Device alarm issue | 25.50 | 16.99 | 11 | 17155 | 1519 | 63470337 |
| Lower respiratory tract infection | 25.37 | 16.99 | 3 | 17163 | 132304 | 63339552 |
| Sinusitis | 25.23 | 16.99 | 15 | 17151 | 226638 | 63245218 |
| Product closure issue | 25.20 | 16.99 | 4 | 17162 | 6 | 63471850 |
| White blood cell count decreased | 24.68 | 16.99 | 4 | 17162 | 139100 | 63332756 |
| Sensory disturbance | 24.60 | 16.99 | 24 | 17142 | 13648 | 63458208 |
| Allodynia | 24.57 | 16.99 | 9 | 17157 | 810 | 63471046 |
| Device failure | 24.54 | 16.99 | 17 | 17149 | 5994 | 63465862 |
| Obstetric procedure complication | 24.47 | 16.99 | 4 | 17162 | 8 | 63471848 |
| Myopathy toxic | 24.32 | 16.99 | 8 | 17158 | 522 | 63471334 |
| Glossodynia | 24.28 | 16.99 | 9 | 17157 | 178867 | 63292989 |
| Chondromalacia | 24.24 | 16.99 | 7 | 17159 | 295 | 63471561 |
| Maternal drugs affecting foetus | 24.21 | 16.99 | 16 | 17150 | 5226 | 63466630 |
| Mental status changes | 23.45 | 16.99 | 40 | 17126 | 39559 | 63432297 |
| Contraindicated product administered | 23.40 | 16.99 | 15 | 17151 | 217633 | 63254223 |
| Mean arterial pressure decreased | 23.35 | 16.99 | 6 | 17160 | 162 | 63471694 |
| Arthralgia | 23.13 | 16.99 | 78 | 17088 | 569632 | 62902224 |
| Accidental overdose | 23.13 | 16.99 | 30 | 17136 | 23279 | 63448577 |
| Cancer pain | 23.08 | 16.99 | 13 | 17153 | 3192 | 63468664 |
| Alopecia | 22.81 | 16.99 | 35 | 17131 | 337501 | 63134355 |
| Anaemia | 22.25 | 16.99 | 28 | 17138 | 293402 | 63178454 |
| Completed suicide | 22.13 | 16.99 | 6 | 17160 | 145667 | 63326189 |
| Stridor | 21.98 | 16.99 | 13 | 17153 | 3497 | 63468359 |
| Drug intolerance | 21.84 | 16.99 | 31 | 17135 | 308630 | 63163226 |
| Trigeminal palsy | 21.70 | 16.99 | 4 | 17162 | 20 | 63471836 |
| Nervous system disorder | 21.57 | 16.99 | 26 | 17140 | 18740 | 63453116 |
| Incision site pain | 21.54 | 16.99 | 9 | 17157 | 1149 | 63470707 |
| Cardiac output increased | 21.48 | 16.99 | 6 | 17160 | 224 | 63471632 |
| Blood pressure systolic decreased | 21.39 | 16.99 | 17 | 17149 | 7380 | 63464476 |
| Arthrofibrosis | 21.23 | 16.99 | 4 | 17162 | 23 | 63471833 |
| Adverse drug reaction | 21.01 | 16.99 | 58 | 17108 | 79656 | 63392200 |
| Blood pressure immeasurable | 21.00 | 16.99 | 9 | 17157 | 1223 | 63470633 |
| Anaesthetic complication neurological | 20.66 | 16.99 | 6 | 17160 | 258 | 63471598 |
| Hypercholesterolaemia | 20.46 | 16.99 | 27 | 17139 | 21307 | 63450549 |
| Hand deformity | 20.05 | 16.99 | 9 | 17157 | 159448 | 63312408 |
| Hypoaesthesia oral | 20.02 | 16.99 | 21 | 17145 | 13012 | 63458844 |
| Ventricular fibrillation | 19.82 | 16.99 | 20 | 17146 | 11847 | 63460009 |
| Atrioventricular block complete | 19.76 | 16.99 | 17 | 17149 | 8234 | 63463622 |
| Influenza | 19.57 | 16.99 | 3 | 17163 | 108719 | 63363137 |
| Product administration error | 19.43 | 16.99 | 27 | 17139 | 22370 | 63449486 |
| Infusion site mass | 19.40 | 16.99 | 10 | 17156 | 2058 | 63469798 |
| Infection | 19.40 | 16.99 | 20 | 17146 | 229153 | 63242703 |
| Brachial plexopathy | 19.39 | 16.99 | 5 | 17161 | 137 | 63471719 |
| Agitation | 19.37 | 16.99 | 47 | 17119 | 59710 | 63412146 |
| Device malfunction | 19.33 | 16.99 | 24 | 17142 | 17833 | 63454023 |
| Neurogenic shock | 19.27 | 16.99 | 6 | 17160 | 328 | 63471528 |
| Abdominal discomfort | 19.17 | 16.99 | 36 | 17130 | 320849 | 63151007 |
| Radiculopathy | 19.13 | 16.99 | 17 | 17149 | 8594 | 63463262 |
| Seroma | 19.12 | 16.99 | 10 | 17156 | 2121 | 63469735 |
| Status epilepticus | 18.99 | 16.99 | 22 | 17144 | 15211 | 63456645 |
| Myalgia | 18.85 | 16.99 | 8 | 17158 | 146521 | 63325335 |
| Vocal cord paralysis | 18.81 | 16.99 | 10 | 17156 | 2191 | 63469665 |
| Ventricular hypokinesia | 18.65 | 16.99 | 13 | 17153 | 4631 | 63467225 |
| Intraocular pressure fluctuation | 18.62 | 16.99 | 4 | 17162 | 48 | 63471808 |
| Synovitis | 18.61 | 16.99 | 14 | 17152 | 186904 | 63284952 |
| Sphincter of Oddi dysfunction | 18.18 | 16.99 | 6 | 17160 | 396 | 63471460 |
| Peroneal nerve palsy | 18.17 | 16.99 | 13 | 17153 | 4822 | 63467034 |
| Spinal cord haematoma | 18.08 | 16.99 | 5 | 17161 | 180 | 63471676 |
| Contusion | 18.05 | 16.99 | 9 | 17157 | 150035 | 63321821 |
| Maternal use of illicit drugs | 18.04 | 16.99 | 3 | 17163 | 7 | 63471849 |
| Manipulation | 17.92 | 16.99 | 4 | 17162 | 58 | 63471798 |
| Implant site pain | 17.85 | 16.99 | 10 | 17156 | 2430 | 63469426 |
| Hypovolaemia | 17.84 | 16.99 | 18 | 17148 | 10655 | 63461201 |
| Therapeutic product effect variable | 17.82 | 16.99 | 8 | 17158 | 1215 | 63470641 |
| Febrile neutropenia | 17.76 | 16.99 | 5 | 17161 | 118444 | 63353412 |
| Rotator cuff syndrome | 17.68 | 16.99 | 20 | 17146 | 13482 | 63458374 |
| Stroke volume increased | 17.49 | 16.99 | 3 | 17163 | 9 | 63471847 |
| Pericarditis | 17.22 | 16.99 | 7 | 17159 | 131572 | 63340284 |
| Respiratory distress | 17.16 | 16.99 | 32 | 17134 | 33919 | 63437937 |
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 | 714.35 | 22.24 | 136 | 8121 | 984 | 34947690 |
| Chondrolysis | 258.17 | 22.24 | 41 | 8216 | 77 | 34948597 |
| Local anaesthetic systemic toxicity | 224.96 | 22.24 | 42 | 8215 | 268 | 34948406 |
| Drug withdrawal syndrome | 129.69 | 22.24 | 72 | 8185 | 19762 | 34928912 |
| Pain | 128.03 | 22.24 | 196 | 8061 | 204479 | 34744195 |
| Drug ineffective | 116.98 | 22.24 | 300 | 7957 | 456451 | 34492223 |
| Cauda equina syndrome | 99.91 | 22.24 | 24 | 8233 | 562 | 34948112 |
| Hypoaesthesia | 81.84 | 22.24 | 86 | 8171 | 61358 | 34887316 |
| Paralysis | 81.47 | 22.24 | 36 | 8221 | 6046 | 34942628 |
| Respiratory depression | 77.23 | 22.24 | 48 | 8209 | 16197 | 34932477 |
| Hyperaesthesia | 73.83 | 22.24 | 31 | 8226 | 4599 | 34944075 |
| Lagophthalmos | 68.82 | 22.24 | 13 | 8244 | 89 | 34948585 |
| Bradycardia | 65.92 | 22.24 | 85 | 8172 | 75333 | 34873341 |
| Incorrect route of product administration | 65.89 | 22.24 | 42 | 8215 | 14803 | 34933871 |
| Spinal cord infarction | 65.26 | 22.24 | 15 | 8242 | 288 | 34948386 |
| Sinus arrest | 62.04 | 22.24 | 21 | 8236 | 1719 | 34946955 |
| Cardiotoxicity | 58.61 | 22.24 | 28 | 8229 | 5620 | 34943054 |
| Medical device site pain | 52.74 | 22.24 | 10 | 8247 | 70 | 34948604 |
| Myoclonus | 51.68 | 22.24 | 36 | 8221 | 14689 | 34933985 |
| Paraplegia | 51.51 | 22.24 | 21 | 8236 | 2890 | 34945784 |
| Hypotension | 50.53 | 22.24 | 140 | 8117 | 221509 | 34727165 |
| Cardiac arrest | 50.12 | 22.24 | 85 | 8172 | 96074 | 34852600 |
| Retinal artery occlusion | 49.06 | 22.24 | 18 | 8239 | 1867 | 34946807 |
| Post procedural hypotension | 47.10 | 22.24 | 9 | 8248 | 66 | 34948608 |
| Generalised tonic-clonic seizure | 46.17 | 22.24 | 39 | 8218 | 21135 | 34927539 |
| Apnoea | 45.74 | 22.24 | 25 | 8232 | 6639 | 34942035 |
| Corneal reflex decreased | 45.05 | 22.24 | 10 | 8247 | 163 | 34948511 |
| Device malfunction | 45.03 | 22.24 | 29 | 8228 | 10392 | 34938282 |
| Sensory loss | 45.02 | 22.24 | 22 | 8235 | 4637 | 34944037 |
| Device failure | 45.00 | 22.24 | 18 | 8239 | 2358 | 34946316 |
| Autonomic nervous system imbalance | 43.77 | 22.24 | 18 | 8239 | 2533 | 34946141 |
| Arachnoiditis | 42.17 | 22.24 | 11 | 8246 | 363 | 34948311 |
| Loss of consciousness | 41.65 | 22.24 | 72 | 8185 | 82595 | 34866079 |
| Oculocardiac reflex | 41.36 | 22.24 | 8 | 8249 | 63 | 34948611 |
| Implant site extravasation | 41.24 | 22.24 | 11 | 8246 | 396 | 34948278 |
| Device infusion issue | 40.91 | 22.24 | 13 | 8244 | 872 | 34947802 |
| Areflexia | 40.78 | 22.24 | 18 | 8239 | 3013 | 34945661 |
| Sodium retention | 40.02 | 22.24 | 8 | 8249 | 76 | 34948598 |
| Therapeutic product effect delayed | 39.82 | 22.24 | 14 | 8243 | 1284 | 34947390 |
| Anal incontinence | 39.34 | 22.24 | 24 | 8233 | 7825 | 34940849 |
| Anal sphincter atony | 38.87 | 22.24 | 8 | 8249 | 89 | 34948585 |
| Premature baby | 38.43 | 22.24 | 34 | 8223 | 19599 | 34929075 |
| Sedation | 38.39 | 22.24 | 35 | 8222 | 20971 | 34927703 |
| Renin increased | 38.24 | 22.24 | 8 | 8249 | 97 | 34948577 |
| Spinal shock | 37.71 | 22.24 | 7 | 8250 | 43 | 34948631 |
| Procedural pain | 35.69 | 22.24 | 19 | 8238 | 4787 | 34943887 |
| Amaurosis | 35.47 | 22.24 | 11 | 8246 | 681 | 34947993 |
| Arthrofibrosis | 34.88 | 22.24 | 7 | 8250 | 68 | 34948606 |
| Neurotoxicity | 34.87 | 22.24 | 31 | 8226 | 17979 | 34930695 |
| Pneumonia | 34.00 | 22.24 | 22 | 8235 | 362605 | 34586069 |
| Therapy non-responder | 33.96 | 22.24 | 44 | 8213 | 39102 | 34909572 |
| Delayed recovery from anaesthesia | 33.89 | 22.24 | 11 | 8246 | 790 | 34947884 |
| Anaesthetic complication neurological | 33.58 | 22.24 | 9 | 8248 | 330 | 34948344 |
| Symmetrical drug-related intertriginous and flexural exanthema | 33.12 | 22.24 | 9 | 8248 | 348 | 34948326 |
| Myopathy toxic | 32.95 | 22.24 | 10 | 8247 | 576 | 34948098 |
| Device power source issue | 32.61 | 22.24 | 9 | 8248 | 369 | 34948305 |
| Acute kidney injury | 32.16 | 22.24 | 16 | 8241 | 304972 | 34643702 |
| Procedural complication | 32.00 | 22.24 | 17 | 8240 | 4266 | 34944408 |
| Paroxysmal sympathetic hyperactivity | 31.90 | 22.24 | 6 | 8251 | 40 | 34948634 |
| Paraparesis | 31.29 | 22.24 | 13 | 8244 | 1876 | 34946798 |
| Electrocardiogram T wave amplitude increased | 31.05 | 22.24 | 6 | 8251 | 47 | 34948627 |
| Unresponsive to stimuli | 30.42 | 22.24 | 35 | 8222 | 27534 | 34921140 |
| Coma | 30.13 | 22.24 | 45 | 8212 | 45633 | 34903041 |
| Urinary incontinence | 29.80 | 22.24 | 29 | 8228 | 18845 | 34929829 |
| Low birth weight baby | 29.31 | 22.24 | 20 | 8237 | 7885 | 34940789 |
| Post procedural complication | 29.07 | 22.24 | 23 | 8234 | 11365 | 34937309 |
| Infusion site mass | 28.76 | 22.24 | 8 | 8249 | 338 | 34948336 |
| Muscular weakness | 28.55 | 22.24 | 57 | 8200 | 72840 | 34875834 |
| Muscle rigidity | 28.49 | 22.24 | 22 | 8235 | 10496 | 34938178 |
| Axillary pain | 27.95 | 22.24 | 8 | 8249 | 375 | 34948299 |
| Jaundice cholestatic | 27.52 | 22.24 | 16 | 8241 | 4778 | 34943896 |
| Brief psychotic disorder with marked stressors | 27.04 | 22.24 | 7 | 8250 | 224 | 34948450 |
| Foetal exposure during delivery | 26.57 | 22.24 | 6 | 8251 | 106 | 34948568 |
| Overdose | 26.32 | 22.24 | 63 | 8194 | 90996 | 34857678 |
| Diaphragmatic paralysis | 26.06 | 22.24 | 8 | 8249 | 479 | 34948195 |
| Anaphylactic reaction | 25.99 | 22.24 | 35 | 8222 | 32266 | 34916408 |
| Tachycardia | 25.97 | 22.24 | 60 | 8197 | 84712 | 34863962 |
| No adverse event | 25.11 | 22.24 | 29 | 8228 | 22898 | 34925776 |
| Brown-Sequard syndrome | 25.06 | 22.24 | 5 | 8252 | 47 | 34948627 |
| Apgar score low | 24.98 | 22.24 | 9 | 8248 | 886 | 34947788 |
| Implant site erythema | 24.96 | 22.24 | 5 | 8252 | 48 | 34948626 |
| Mental status changes | 24.37 | 22.24 | 37 | 8220 | 38046 | 34910628 |
| Sinus tachycardia | 24.32 | 22.24 | 25 | 8232 | 17335 | 34931339 |
| Complication associated with device | 24.20 | 22.24 | 16 | 8241 | 5990 | 34942684 |
| Thrombocytopenia | 24.08 | 22.24 | 4 | 8253 | 156243 | 34792431 |
| Hypercapnia | 23.89 | 22.24 | 14 | 8243 | 4241 | 34944433 |
| Anaemia | 23.45 | 22.24 | 13 | 8244 | 233322 | 34715352 |
| Diarrhoea | 23.44 | 22.24 | 35 | 8222 | 389877 | 34558797 |
| Chondromalacia | 23.39 | 22.24 | 4 | 8253 | 14 | 34948660 |
| Device issue | 23.37 | 22.24 | 19 | 8238 | 9758 | 34938916 |
| Inadequate analgesia | 22.76 | 22.24 | 12 | 8245 | 2963 | 34945711 |
| Meningitis chemical | 22.61 | 22.24 | 5 | 8252 | 80 | 34948594 |
| Strabismus | 22.38 | 22.24 | 10 | 8247 | 1721 | 34946953 |
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 | 1911.15 | 15.05 | 368 | 20829 | 2491 | 79720700 |
| Maternal exposure during delivery | 561.11 | 15.05 | 117 | 21080 | 1229 | 79721962 |
| Chondrolysis | 526.22 | 15.05 | 90 | 21107 | 271 | 79722920 |
| Maternal exposure during pregnancy | 441.25 | 15.05 | 332 | 20865 | 136206 | 79586985 |
| Exposure during pregnancy | 342.30 | 15.05 | 253 | 20944 | 100879 | 79622312 |
| Drug ineffective | 304.52 | 15.05 | 792 | 20405 | 1080121 | 78643070 |
| Cauda equina syndrome | 296.93 | 15.05 | 70 | 21127 | 1333 | 79721858 |
| Local anaesthetic systemic toxicity | 283.98 | 15.05 | 64 | 21133 | 990 | 79722201 |
| Drug withdrawal syndrome | 247.62 | 15.05 | 139 | 21058 | 34579 | 79688612 |
| Hypotension | 242.37 | 15.05 | 425 | 20772 | 439892 | 79283299 |
| Bradycardia | 225.85 | 15.05 | 226 | 20971 | 135331 | 79587860 |
| Incorrect route of product administration | 199.24 | 15.05 | 121 | 21076 | 34808 | 79688383 |
| Paralysis | 189.74 | 15.05 | 85 | 21112 | 13092 | 79710099 |
| Normal newborn | 167.28 | 15.05 | 65 | 21132 | 7007 | 79716184 |
| Respiratory depression | 163.46 | 15.05 | 98 | 21099 | 27532 | 79695659 |
| Lagophthalmos | 158.77 | 15.05 | 34 | 21163 | 409 | 79722782 |
| Premature delivery | 153.96 | 15.05 | 89 | 21108 | 23378 | 79699813 |
| Hyperaesthesia | 145.20 | 15.05 | 69 | 21128 | 12153 | 79711038 |
| Myoclonus | 133.00 | 15.05 | 86 | 21111 | 27574 | 79695617 |
| Implant site extravasation | 132.94 | 15.05 | 33 | 21164 | 786 | 79722405 |
| Hypoaesthesia | 129.29 | 15.05 | 196 | 21001 | 179156 | 79544035 |
| Cardiac arrest | 126.79 | 15.05 | 190 | 21007 | 171906 | 79551285 |
| Anterior spinal artery syndrome | 124.54 | 15.05 | 23 | 21174 | 119 | 79723072 |
| Apnoea | 120.75 | 15.05 | 60 | 21137 | 11644 | 79711547 |
| Unresponsive to stimuli | 119.49 | 15.05 | 107 | 21090 | 55681 | 79667510 |
| Extradural haematoma | 115.15 | 15.05 | 39 | 21158 | 2837 | 79720354 |
| Paraplegia | 110.91 | 15.05 | 44 | 21153 | 5009 | 79718182 |
| Arachnoiditis | 109.48 | 15.05 | 28 | 21169 | 755 | 79722436 |
| Spinal cord injury | 108.88 | 15.05 | 31 | 21166 | 1264 | 79721927 |
| Medical device site pain | 105.68 | 15.05 | 23 | 21174 | 300 | 79722891 |
| Spinal cord infarction | 105.64 | 15.05 | 26 | 21171 | 597 | 79722594 |
| Diarrhoea | 101.62 | 15.05 | 54 | 21143 | 880435 | 78842756 |
| Sensory loss | 98.00 | 15.05 | 54 | 21143 | 12937 | 79710254 |
| Inadequate analgesia | 97.06 | 15.05 | 39 | 21158 | 4590 | 79718601 |
| Sedation | 96.51 | 15.05 | 92 | 21105 | 51803 | 79671388 |
| Generalised tonic-clonic seizure | 95.56 | 15.05 | 85 | 21112 | 43825 | 79679366 |
| Wrong product administered | 89.43 | 15.05 | 45 | 21152 | 8967 | 79714224 |
| Anaphylactic reaction | 88.19 | 15.05 | 110 | 21087 | 83633 | 79639558 |
| Ventilation perfusion mismatch | 85.15 | 15.05 | 22 | 21175 | 618 | 79722573 |
| Fatigue | 83.41 | 15.05 | 75 | 21122 | 929652 | 78793539 |
| Loss of consciousness | 82.87 | 15.05 | 155 | 21042 | 167788 | 79555403 |
| Delayed recovery from anaesthesia | 80.24 | 15.05 | 26 | 21171 | 1647 | 79721544 |
| Pneumonia | 75.31 | 15.05 | 41 | 21156 | 660205 | 79062986 |
| Meningitis chemical | 73.28 | 15.05 | 16 | 21181 | 212 | 79722979 |
| Live birth | 72.65 | 15.05 | 51 | 21146 | 18693 | 79704498 |
| Acute kidney injury | 72.38 | 15.05 | 24 | 21173 | 519380 | 79203811 |
| Post procedural complication | 70.27 | 15.05 | 55 | 21142 | 23774 | 79699417 |
| Procedural complication | 68.07 | 15.05 | 36 | 21161 | 7947 | 79715244 |
| Device failure | 67.26 | 15.05 | 33 | 21164 | 6228 | 79716963 |
| Rhythm idioventricular | 66.54 | 15.05 | 18 | 21179 | 606 | 79722585 |
| No adverse event | 65.49 | 15.05 | 64 | 21133 | 37128 | 79686063 |
| Anaphylactic shock | 65.37 | 15.05 | 63 | 21134 | 35933 | 79687258 |
| Caesarean section | 65.28 | 15.05 | 41 | 21156 | 12494 | 79710697 |
| Purtscher retinopathy | 64.54 | 15.05 | 13 | 21184 | 113 | 79723078 |
| Device infusion issue | 60.81 | 15.05 | 23 | 21174 | 2303 | 79720888 |
| Retinal artery occlusion | 59.68 | 15.05 | 25 | 21172 | 3269 | 79719922 |
| Horner's syndrome | 58.99 | 15.05 | 10 | 21187 | 28 | 79723163 |
| Diplegia | 58.87 | 15.05 | 21 | 21176 | 1782 | 79721409 |
| Spinal anaesthesia | 58.76 | 15.05 | 11 | 21186 | 62 | 79723129 |
| Bradycardia foetal | 57.88 | 15.05 | 12 | 21185 | 122 | 79723069 |
| Procedural pain | 56.92 | 15.05 | 48 | 21149 | 23036 | 79700155 |
| Post procedural hypotension | 56.59 | 15.05 | 11 | 21186 | 78 | 79723113 |
| Myopathy toxic | 56.49 | 15.05 | 18 | 21179 | 1080 | 79722111 |
| Blood pressure decreased | 55.64 | 15.05 | 97 | 21100 | 99369 | 79623822 |
| Neurotoxicity | 55.47 | 15.05 | 55 | 21142 | 32463 | 79690728 |
| Spinal cord oedema | 54.61 | 15.05 | 14 | 21183 | 381 | 79722810 |
| Sinus arrest | 54.16 | 15.05 | 24 | 21173 | 3598 | 79719593 |
| Post lumbar puncture syndrome | 54.06 | 15.05 | 16 | 21181 | 749 | 79722442 |
| Therapeutic product effect prolonged | 53.85 | 15.05 | 15 | 21182 | 564 | 79722627 |
| Neuromuscular blockade | 53.83 | 15.05 | 15 | 21182 | 565 | 79722626 |
| Arthrofibrosis | 53.49 | 15.05 | 11 | 21186 | 107 | 79723084 |
| Seizure | 52.96 | 15.05 | 139 | 21058 | 188695 | 79534496 |
| Complication associated with device | 52.92 | 15.05 | 41 | 21156 | 17455 | 79705736 |
| Neutropenia | 52.85 | 15.05 | 7 | 21190 | 287703 | 79435488 |
| Anaesthetic complication neurological | 52.27 | 15.05 | 15 | 21182 | 629 | 79722562 |
| Therapeutic product effect delayed | 51.47 | 15.05 | 22 | 21175 | 3024 | 79720167 |
| Hypothermia | 51.41 | 15.05 | 45 | 21152 | 22701 | 79700490 |
| Rash | 51.31 | 15.05 | 47 | 21150 | 578311 | 79144880 |
| Overdose | 51.06 | 15.05 | 135 | 21062 | 184071 | 79539120 |
| Muscular weakness | 51.01 | 15.05 | 124 | 21073 | 160605 | 79562586 |
| Haemodynamic instability | 50.99 | 15.05 | 40 | 21157 | 17342 | 79705849 |
| Ventricular tachycardia | 50.52 | 15.05 | 59 | 21138 | 41876 | 79681315 |
| Platelet aggregation inhibition | 50.16 | 15.05 | 11 | 21186 | 149 | 79723042 |
| Parophthalmia | 49.69 | 15.05 | 13 | 21184 | 384 | 79722807 |
| Hypoxia | 49.28 | 15.05 | 94 | 21103 | 103149 | 79620042 |
| Depressed level of consciousness | 48.62 | 15.05 | 90 | 21107 | 96562 | 79626629 |
| Strabismus | 48.60 | 15.05 | 20 | 21177 | 2501 | 79720690 |
| Areflexia | 47.31 | 15.05 | 25 | 21172 | 5509 | 79717682 |
| Kounis syndrome | 47.29 | 15.05 | 23 | 21174 | 4259 | 79718932 |
| Pain | 46.60 | 15.05 | 333 | 20864 | 703469 | 79019722 |
| Vascular resistance systemic decreased | 46.42 | 15.05 | 11 | 21186 | 214 | 79722977 |
| Hypertensive encephalopathy | 46.03 | 15.05 | 15 | 21182 | 967 | 79722224 |
| Monoplegia | 45.88 | 15.05 | 22 | 21175 | 3949 | 79719242 |
| Arachnoid web | 45.78 | 15.05 | 7 | 21190 | 7 | 79723184 |
| Spinal shock | 44.80 | 15.05 | 8 | 21189 | 33 | 79723158 |
| Pyrexia | 44.43 | 15.05 | 70 | 21127 | 678639 | 79044552 |
| Spinal cord compression | 43.99 | 15.05 | 25 | 21172 | 6352 | 79716839 |
| Febrile neutropenia | 43.94 | 15.05 | 5 | 21192 | 230994 | 79492197 |
| Rheumatoid arthritis | 43.73 | 15.05 | 3 | 21194 | 208467 | 79514724 |
| Mental status changes | 43.72 | 15.05 | 70 | 21127 | 66889 | 79656302 |
| Conjunctival oedema | 43.61 | 15.05 | 15 | 21182 | 1143 | 79722048 |
| Anal incontinence | 43.19 | 15.05 | 37 | 21160 | 18131 | 79705060 |
| Chondromalacia | 43.09 | 15.05 | 10 | 21187 | 177 | 79723014 |
| Cancer pain | 42.88 | 15.05 | 23 | 21174 | 5222 | 79717969 |
| Completed suicide | 42.77 | 15.05 | 7 | 21190 | 245760 | 79477431 |
| Autonomic nervous system imbalance | 42.68 | 15.05 | 22 | 21175 | 4608 | 79718583 |
| Postpartum haemorrhage | 42.52 | 15.05 | 16 | 21181 | 1579 | 79721612 |
| Nasopharyngitis | 42.51 | 15.05 | 8 | 21189 | 253873 | 79469318 |
| Tachycardia | 42.06 | 15.05 | 123 | 21074 | 177645 | 79545546 |
| Allodynia | 42.01 | 15.05 | 16 | 21181 | 1632 | 79721559 |
| Cough | 41.41 | 15.05 | 23 | 21174 | 366766 | 79356425 |
| Neuromuscular block prolonged | 41.36 | 15.05 | 14 | 21183 | 1016 | 79722175 |
| Anaemia | 40.83 | 15.05 | 35 | 21162 | 444980 | 79278211 |
| Oculocardiac reflex | 40.42 | 15.05 | 8 | 21189 | 63 | 79723128 |
| Labelled drug-drug interaction medication error | 40.34 | 15.05 | 43 | 21154 | 27607 | 79695584 |
| Ophthalmoplegia | 39.42 | 15.05 | 18 | 21179 | 2894 | 79720297 |
| Death | 38.42 | 15.05 | 57 | 21140 | 566457 | 79156734 |
| Uterine atony | 37.99 | 15.05 | 9 | 21188 | 175 | 79723016 |
| Mental status changes postoperative | 37.94 | 15.05 | 9 | 21188 | 176 | 79723015 |
| Device malfunction | 37.92 | 15.05 | 37 | 21160 | 21411 | 79701780 |
| Exophthalmos | 37.74 | 15.05 | 15 | 21182 | 1715 | 79721476 |
| Infusion related reaction | 36.99 | 15.05 | 8 | 21189 | 230229 | 79492962 |
| Sensory disturbance | 36.44 | 15.05 | 31 | 21166 | 15046 | 79708145 |
| Corneal reflex decreased | 36.35 | 15.05 | 10 | 21187 | 359 | 79722832 |
| Hypercapnia | 36.23 | 15.05 | 25 | 21172 | 8910 | 79714281 |
| Pulseless electrical activity | 36.05 | 15.05 | 30 | 21167 | 14130 | 79709061 |
| Cardiotoxicity | 35.54 | 15.05 | 28 | 21169 | 12211 | 79710980 |
| Product administration error | 35.38 | 15.05 | 43 | 21154 | 31803 | 79691388 |
| Sensorimotor disorder | 35.30 | 15.05 | 12 | 21185 | 882 | 79722309 |
| Intracranial hypotension | 35.16 | 15.05 | 10 | 21187 | 406 | 79722785 |
| Decreased appetite | 35.13 | 15.05 | 24 | 21173 | 342394 | 79380797 |
| Motor dysfunction | 35.01 | 15.05 | 30 | 21167 | 14703 | 79708488 |
| Sinus tachycardia | 34.92 | 15.05 | 46 | 21151 | 36862 | 79686329 |
| Paraparesis | 34.85 | 15.05 | 18 | 21179 | 3785 | 79719406 |
| Harlequin syndrome | 34.63 | 15.05 | 7 | 21190 | 62 | 79723129 |
| Peripartum cardiomyopathy | 34.51 | 15.05 | 8 | 21189 | 141 | 79723050 |
| Urinary incontinence | 34.18 | 15.05 | 48 | 21149 | 40861 | 79682330 |
| Neuralgia | 33.76 | 15.05 | 43 | 21154 | 33341 | 79689850 |
| White blood cell count decreased | 33.58 | 15.05 | 5 | 21192 | 188283 | 79534908 |
| General physical health deterioration | 32.92 | 15.05 | 16 | 21181 | 275222 | 79447969 |
| Myelitis transverse | 32.69 | 15.05 | 14 | 21183 | 1933 | 79721258 |
| Circulatory collapse | 32.67 | 15.05 | 45 | 21152 | 37623 | 79685568 |
| Arteriospasm coronary | 32.56 | 15.05 | 21 | 21176 | 6695 | 79716496 |
| Therapy non-responder | 32.29 | 15.05 | 74 | 21123 | 92231 | 79630960 |
| Drug intolerance | 32.13 | 15.05 | 15 | 21182 | 264104 | 79459087 |
| Necrotising fasciitis | 32.03 | 15.05 | 20 | 21177 | 6030 | 79717161 |
| Weight increased | 31.87 | 15.05 | 17 | 21180 | 277369 | 79445822 |
| Radiculopathy | 31.86 | 15.05 | 23 | 21174 | 8801 | 79714390 |
| Product dose omission issue | 31.78 | 15.05 | 13 | 21184 | 247524 | 79475667 |
| Blood pressure immeasurable | 31.65 | 15.05 | 14 | 21183 | 2090 | 79721101 |
| Product quality issue | 31.65 | 15.05 | 42 | 21155 | 33898 | 79689293 |
| Confusion postoperative | 31.34 | 15.05 | 8 | 21189 | 214 | 79722977 |
| Peripheral swelling | 30.28 | 15.05 | 17 | 21180 | 269600 | 79453591 |
| Alopecia | 29.95 | 15.05 | 12 | 21185 | 231343 | 79491848 |
| Conus medullaris syndrome | 29.80 | 15.05 | 6 | 21191 | 52 | 79723139 |
| Uterine hypertonus | 29.75 | 15.05 | 8 | 21189 | 263 | 79722928 |
| Respiratory rate decreased | 29.45 | 15.05 | 18 | 21179 | 5225 | 79717966 |
| Respiratory arrest | 29.44 | 15.05 | 54 | 21143 | 57496 | 79665695 |
| Thrombocytopenia | 29.39 | 15.05 | 17 | 21180 | 265242 | 79457949 |
| Systemic toxicity | 29.13 | 15.05 | 7 | 21190 | 145 | 79723046 |
| Pulse absent | 29.09 | 15.05 | 23 | 21174 | 10080 | 79713111 |
| Diaphragmatic paralysis | 29.08 | 15.05 | 11 | 21186 | 1101 | 79722090 |
| Diplopia | 29.05 | 15.05 | 40 | 21157 | 33426 | 79689765 |
| Arthritis bacterial | 28.86 | 15.05 | 22 | 21175 | 9144 | 79714047 |
| Urinary retention | 28.80 | 15.05 | 53 | 21144 | 56577 | 79666614 |
| Infusion site mass | 28.56 | 15.05 | 12 | 21185 | 1581 | 79721610 |
| Brown-Sequard syndrome | 28.51 | 15.05 | 6 | 21191 | 66 | 79723125 |
| Disease progression | 28.43 | 15.05 | 7 | 21190 | 184355 | 79538836 |
| Amaurosis | 28.35 | 15.05 | 11 | 21186 | 1180 | 79722011 |
| Anal sphincter atony | 28.00 | 15.05 | 8 | 21189 | 330 | 79722861 |
| Phrenic nerve paralysis | 27.93 | 15.05 | 8 | 21189 | 333 | 79722858 |
| Weight decreased | 27.89 | 15.05 | 32 | 21165 | 355166 | 79368025 |
| Medical device site erythema | 27.59 | 15.05 | 6 | 21191 | 78 | 79723113 |
| Manipulation | 27.59 | 15.05 | 6 | 21191 | 78 | 79723113 |
| Bezold-Jarisch reflex | 27.56 | 15.05 | 5 | 21192 | 23 | 79723168 |
| Paresis | 27.51 | 15.05 | 16 | 21181 | 4245 | 79718946 |
| Arthralgia | 27.11 | 15.05 | 71 | 21126 | 571732 | 79151459 |
| Device power source issue | 26.91 | 15.05 | 10 | 21187 | 953 | 79722238 |
| Abdominal discomfort | 26.48 | 15.05 | 17 | 21180 | 250710 | 79472481 |
| Adverse drug reaction | 26.35 | 15.05 | 56 | 21141 | 66336 | 79656855 |
| Gastrointestinal haemorrhage | 26.16 | 15.05 | 4 | 21193 | 147715 | 79575476 |
| Unmasking of previously unidentified disease | 25.61 | 15.05 | 12 | 21185 | 2045 | 79721146 |
| Peroneal nerve palsy | 24.72 | 15.05 | 17 | 21180 | 6025 | 79717166 |
| Cerebrospinal fluid leakage | 24.58 | 15.05 | 11 | 21186 | 1688 | 79721503 |
| Brugada syndrome | 24.47 | 15.05 | 10 | 21187 | 1228 | 79721963 |
| Seroma | 24.34 | 15.05 | 12 | 21185 | 2288 | 79720903 |
| Rotator cuff syndrome | 24.33 | 15.05 | 24 | 21173 | 14071 | 79709120 |
| Brief psychotic disorder with marked stressors | 24.20 | 15.05 | 7 | 21190 | 302 | 79722889 |
| Symmetrical drug-related intertriginous and flexural exanthema | 24.03 | 15.05 | 9 | 21188 | 877 | 79722314 |
| Spinal cord haematoma | 23.85 | 15.05 | 7 | 21190 | 318 | 79722873 |
| Product closure issue | 23.65 | 15.05 | 4 | 21193 | 11 | 79723180 |
| Dehydration | 23.37 | 15.05 | 19 | 21178 | 248168 | 79475023 |
| Arthropathy | 23.22 | 15.05 | 9 | 21188 | 177102 | 79546089 |
| Toxicity to various agents | 23.06 | 15.05 | 191 | 21006 | 421349 | 79301842 |
| Extradural abscess | 22.55 | 15.05 | 10 | 21187 | 1502 | 79721689 |
| Renal impairment | 22.44 | 15.05 | 7 | 21190 | 157776 | 79565415 |
| Device alarm issue | 22.41 | 15.05 | 11 | 21186 | 2078 | 79721113 |
| Product measured potency issue | 22.21 | 15.05 | 6 | 21191 | 201 | 79722990 |
| Incision site pain | 21.99 | 15.05 | 12 | 21185 | 2818 | 79720373 |
| Sciatic nerve palsy | 21.96 | 15.05 | 5 | 21192 | 81 | 79723110 |
| Medical device site swelling | 21.96 | 15.05 | 5 | 21192 | 81 | 79723110 |
| Somnolence | 21.88 | 15.05 | 123 | 21074 | 238858 | 79484333 |
| Influenza | 21.86 | 15.05 | 4 | 21193 | 129602 | 79593589 |
| Blood creatinine increased | 21.83 | 15.05 | 7 | 21190 | 155050 | 79568141 |
| Hyponatraemia | 21.77 | 15.05 | 10 | 21187 | 177838 | 79545353 |
| Trigeminal palsy | 21.77 | 15.05 | 4 | 21193 | 20 | 79723171 |
| Platelet dysfunction | 21.73 | 15.05 | 7 | 21190 | 435 | 79722756 |
| Hypoglossal nerve disorder | 21.70 | 15.05 | 3 | 21194 | 0 | 79723191 |
| Joint swelling | 21.59 | 15.05 | 27 | 21170 | 288619 | 79434572 |
| Mydriasis | 21.54 | 15.05 | 25 | 21172 | 17618 | 79705573 |
| Accidental overdose | 21.34 | 15.05 | 38 | 21159 | 39543 | 79683648 |
| Urinary tract infection | 21.24 | 15.05 | 25 | 21172 | 274487 | 79448704 |
| Abdominal pain upper | 21.24 | 15.05 | 17 | 21180 | 223802 | 79499389 |
| Muscle rigidity | 20.72 | 15.05 | 26 | 21171 | 19856 | 79703335 |
| Implant site infection | 20.54 | 15.05 | 10 | 21187 | 1855 | 79721336 |
| Cardiac output increased | 20.50 | 15.05 | 6 | 21191 | 270 | 79722921 |
| Ventricular fibrillation | 20.32 | 15.05 | 33 | 21164 | 31893 | 79691298 |
| Nervous system disorder | 20.22 | 15.05 | 30 | 21167 | 26826 | 79696365 |
| Vocal cord paralysis | 20.19 | 15.05 | 11 | 21186 | 2576 | 79720615 |
| Corneal oedema | 20.06 | 15.05 | 11 | 21186 | 2609 | 79720582 |
| Injection site joint infection | 20.04 | 15.05 | 4 | 21193 | 33 | 79723158 |
| Lower respiratory tract infection | 19.73 | 15.05 | 5 | 21192 | 129215 | 79593976 |
| Toxic anterior segment syndrome | 19.51 | 15.05 | 11 | 21186 | 2753 | 79720438 |
| Implant site pain | 19.43 | 15.05 | 10 | 21187 | 2087 | 79721104 |
| Femoral nerve injury | 19.35 | 15.05 | 4 | 21193 | 40 | 79723151 |
| Ventricular extrasystoles | 19.32 | 15.05 | 25 | 21172 | 19679 | 79703512 |
| Spherocytic anaemia | 19.16 | 15.05 | 3 | 21194 | 4 | 79723187 |
| Device connection issue | 19.14 | 15.05 | 8 | 21189 | 1040 | 79722151 |
| Cardiac failure congestive | 19.06 | 15.05 | 7 | 21190 | 142395 | 79580796 |
| Hiccups | 19.05 | 15.05 | 18 | 21179 | 10013 | 79713178 |
| Ventricular arrhythmia | 19.00 | 15.05 | 17 | 21180 | 8823 | 79714368 |
| Hypoaesthesia oral | 18.92 | 15.05 | 21 | 21176 | 14103 | 79709088 |
| Myelopathy | 18.87 | 15.05 | 13 | 21184 | 4620 | 79718571 |
| Brachial plexopathy | 18.55 | 15.05 | 5 | 21192 | 166 | 79723025 |
| Maternal drugs affecting foetus | 18.46 | 15.05 | 9 | 21188 | 1674 | 79721517 |
| Nerve block | 18.46 | 15.05 | 7 | 21190 | 706 | 79722485 |
| Spinal cord ischaemia | 18.38 | 15.05 | 5 | 21192 | 172 | 79723019 |
| Meningitis aseptic | 18.31 | 15.05 | 15 | 21182 | 6913 | 79716278 |
| Electrocardiogram ST segment depression | 18.27 | 15.05 | 13 | 21184 | 4865 | 79718326 |
| Maternal use of illicit drugs | 18.09 | 15.05 | 3 | 21194 | 7 | 79723184 |
| Gastrooesophageal reflux disease | 18.06 | 15.05 | 3 | 21194 | 104243 | 79618948 |
| Medical device site discharge | 17.92 | 15.05 | 4 | 21193 | 59 | 79723132 |
| Interstitial lung disease | 17.90 | 15.05 | 4 | 21193 | 112596 | 79610595 |
| Device leakage | 17.84 | 15.05 | 18 | 21179 | 10838 | 79712353 |
| Fall | 17.84 | 15.05 | 68 | 21129 | 487561 | 79235630 |
| Sphincter of Oddi dysfunction | 17.84 | 15.05 | 6 | 21191 | 427 | 79722764 |
| Urinary retention postoperative | 17.80 | 15.05 | 5 | 21192 | 194 | 79722997 |
| Spinal cord disorder | 17.73 | 15.05 | 9 | 21188 | 1826 | 79721365 |
| Catheter site mass | 17.68 | 15.05 | 4 | 21193 | 63 | 79723128 |
| COVID-19 | 17.61 | 15.05 | 10 | 21187 | 157664 | 79565527 |
| Heart rate increased | 17.51 | 15.05 | 71 | 21126 | 120653 | 79602538 |
| Device kink | 17.45 | 15.05 | 9 | 21188 | 1886 | 79721305 |
| Intraocular pressure fluctuation | 17.45 | 15.05 | 4 | 21193 | 67 | 79723124 |
| Implant site swelling | 17.42 | 15.05 | 6 | 21191 | 459 | 79722732 |
| Respiratory distress | 17.41 | 15.05 | 44 | 21153 | 58295 | 79664896 |
| Device issue | 17.22 | 15.05 | 28 | 21169 | 27080 | 79696111 |
| Drug abuse | 17.21 | 15.05 | 11 | 21186 | 162680 | 79560511 |
| Hepatic enzyme increased | 17.16 | 15.05 | 14 | 21183 | 182596 | 79540595 |
| Hypotonia | 17.00 | 15.05 | 19 | 21178 | 12851 | 79710340 |
| Stridor | 16.97 | 15.05 | 13 | 21184 | 5440 | 79717751 |
| Procedural hypotension | 16.90 | 15.05 | 9 | 21188 | 2014 | 79721177 |
| Implant site scar | 16.89 | 15.05 | 5 | 21192 | 234 | 79722957 |
| Stroke volume increased | 16.87 | 15.05 | 3 | 21194 | 12 | 79723179 |
| Medical device site cellulitis | 16.87 | 15.05 | 3 | 21194 | 12 | 79723179 |
| Leukopenia | 16.87 | 15.05 | 5 | 21192 | 116508 | 79606683 |
| Femoral nerve palsy | 16.64 | 15.05 | 4 | 21193 | 83 | 79723108 |
| Implant site erythema | 16.52 | 15.05 | 6 | 21191 | 536 | 79722655 |
| Staphylococcal infection | 16.40 | 15.05 | 43 | 21154 | 58252 | 79664939 |
| Premature baby | 16.33 | 15.05 | 11 | 21186 | 3769 | 79719422 |
| Medical device site infection | 16.22 | 15.05 | 6 | 21191 | 565 | 79722626 |
| Iatrogenic injury | 16.18 | 15.05 | 8 | 21189 | 1535 | 79721656 |
| Atrioventricular block complete | 16.17 | 15.05 | 21 | 21176 | 16589 | 79706602 |
| Systemic lupus erythematosus | 16.14 | 15.05 | 6 | 21191 | 121143 | 79602048 |
| Tethered cord syndrome | 16.01 | 15.05 | 3 | 21194 | 17 | 79723174 |
| Sinusitis | 16 | 15.05 | 17 | 21180 | 195484 | 79527707 |
| Meningitis | 15.95 | 15.05 | 16 | 21181 | 9566 | 79713625 |
| Anorectal disorder | 15.84 | 15.05 | 9 | 21188 | 2284 | 79720907 |
| Device computer issue | 15.63 | 15.05 | 4 | 21193 | 108 | 79723083 |
| Underdose | 15.58 | 15.05 | 30 | 21167 | 33121 | 79690070 |
| Incision site rash | 15.47 | 15.05 | 3 | 21194 | 21 | 79723170 |
| Neurogenic shock | 15.46 | 15.05 | 6 | 21191 | 644 | 79722547 |
| Myalgia | 15.35 | 15.05 | 16 | 21181 | 185625 | 79537566 |
| Forceps delivery | 15.26 | 15.05 | 4 | 21193 | 119 | 79723072 |
| Hyponatraemic encephalopathy | 15.16 | 15.05 | 5 | 21192 | 335 | 79722856 |
| Foetal heart rate decreased | 15.11 | 15.05 | 3 | 21194 | 24 | 79723167 |
| Meningeal neoplasm | 15.11 | 15.05 | 3 | 21194 | 24 | 79723167 |
| Quadriplegia | 15.05 | 15.05 | 10 | 21187 | 3350 | 79719841 |
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:36333 | local anesthetics |
| CHEBI has role | CHEBI:37733 | EC 3.1.1.8 inhibitor |
| CHEBI has role | CHEBI:37887 | adrenergic blockers |
| CHEBI has role | CHEBI:59941 | amphiphiles |
| CHEBI has role | CHEBI:60186 | SERCA inhibitor |
| CHEBI has role | CHEBI:88188 | allergenic drug |
| MeSH PA | D000777 | Anesthetics |
| MeSH PA | D000779 | Anesthetics, Local |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D002492 | Central Nervous System Depressants |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D018689 | Sensory System Agents |
| FDA EPC | N0000175682 | Amide Local Anesthetic |
| FDA PE | N0000175976 | Local Anesthesia |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 660MG/5ML (132MG/ML) | POSIMIR | INNOCOLL | N204803 | Feb. 1, 2021 | RX | SOLUTION, EXTENDED RELEASE | INFILTRATION | 8153661 | Sept. 15, 2025 | METHOD FOR PROVIDING SUSTAINED LOCAL ANESTHESIA FOR AT LEAST 24 HOURS |
| 660MG/5ML (132MG/ML) | POSIMIR | INNOCOLL | N204803 | Feb. 1, 2021 | RX | SOLUTION, EXTENDED RELEASE | INFILTRATION | 8753665 | Sept. 15, 2025 | METHOD FOR PROVIDING SUSTAINED LOCAL ANESTHESIA FOR AT LEAST 24 HOURS |
| 660MG/5ML (132MG/ML) | POSIMIR | INNOCOLL | N204803 | Feb. 1, 2021 | RX | SOLUTION, EXTENDED RELEASE | INFILTRATION | 8846072 | Sept. 15, 2025 | METHOD FOR PROVIDING SUSTAINED LOCAL ANESTHESIA FOR AT LEAST 24 HOURS |
| 100MG | XARACOLL | INNOCOLL PHARMS | N209511 | Aug. 28, 2020 | RX | 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 |
| 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 |
| 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 |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG | XARACOLL | INNOCOLL PHARMS | N209511 | Aug. 28, 2020 | RX | IMPLANT | IMPLANTATION | Aug. 28, 2023 | NEW PRODUCT |
| 660MG/5ML (132MG/ML) | POSIMIR | INNOCOLL | N204803 | Feb. 1, 2021 | RX | SOLUTION, EXTENDED RELEASE | INFILTRATION | Feb. 1, 2024 | NEW PRODUCT |
| 133MG/10ML (13.3MG/ML) | EXPAREL | PACIRA PHARMS INC | N022496 | Oct. 28, 2011 | RX | INJECTABLE, LIPOSOMAL | INJECTION | March 22, 2024 | NEW PATIENT POPULATION |
| 266MG/20ML (13.3MG/ML) | EXPAREL | PACIRA PHARMS INC | N022496 | Oct. 28, 2011 | RX | INJECTABLE, LIPOSOMAL | INJECTION | March 22, 2024 | NEW PATIENT POPULATION |
| 200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) | ZYNRELEF KIT | HERON THERAPS INC | N211988 | May 12, 2021 | RX | SOLUTION, EXTENDED RELEASE | PERIARTICULAR | May 12, 2024 | NEW PRODUCT |
| 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 | May 12, 2024 | NEW PRODUCT |
| 400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) | ZYNRELEF KIT | HERON THERAPS INC | N211988 | May 12, 2021 | RX | SOLUTION, EXTENDED RELEASE | PERIARTICULAR | May 12, 2024 | NEW PRODUCT |
| 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 | May 12, 2024 | NEW PRODUCT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Sodium channel protein type 4 subunit alpha | Ion channel | BLOCKER | IC50 | 6 | WOMBAT-PK | CHEMBL | |||
| Potassium voltage-gated channel subfamily H member 2 | Ion channel | IC50 | 4.66 | CHEMBL | |||||
| Sodium channel protein type 1 subunit alpha | Ion channel | IC50 | 5.29 | WOMBAT-PK | |||||
| Prostaglandin E2 receptor EP1 subtype | GPCR | IC50 | 5.51 | WOMBAT-PK | |||||
| Cytochrome P450 2D6 | Enzyme | IC50 | 6.40 | DRUG MATRIX | |||||
| 5-hydroxytryptamine receptor 3A | Ion channel | IC50 | 4.23 | WOMBAT-PK | |||||
| Potassium voltage-gated channel subfamily D member 3 | Ion channel | IC50 | 4.50 | WOMBAT-PK | |||||
| Potassium voltage-gated channel subfamily A member 5 | Ion channel | BLOCKER | Kd | 5.40 | IUPHAR | ||||
| Potassium channel subfamily K member 3 | Ion channel | IC50 | 4.39 | CHEMBL | |||||
| Sodium channel protein type 5 subunit alpha | Ion channel | BLOCKER | IC50 | 5.66 | IUPHAR | ||||
| Potassium voltage-gated channel subfamily D member 3 | Ion channel | BLOCKER | IC50 | 4.50 | IUPHAR | ||||
| Potassium channel subfamily K member 3 | Ion channel | IC50 | 4.39 | CHEMBL | |||||
| Potassium channel subfamily K member 9 | Ion channel | 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 |
| DB00297 | DRUGBANK_ID |
| CHEMBL1200396 | ChEMBL_ID |
| D002045 | MESH_DESCRIPTOR_UI |
| C472824 | MESH_SUPPLEMENTAL_RECORD_UI |
| 2474 | PUBCHEM_CID |
| 2397 | IUPHAR_LIGAND_ID |
| 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 |
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 | 22 sections |
| Marcaine | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0362-0557 | INJECTION, SOLUTION | 5 mg | SUBCUTANEOUS | ANDA | 19 sections |
| Vivacaine | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0362-9011 | INJECTION, SOLUTION | 5 mg | SUBCUTANEOUS | ANDA | 19 sections |
| Vivacaine | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0362-9011 | INJECTION, SOLUTION | 5 mg | SUBCUTANEOUS | ANDA | 19 sections |
| Vivacaine | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0362-9011 | INJECTION, SOLUTION | 5 mg | SUBCUTANEOUS | ANDA | 19 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 | 19 sections |
| Bupivacaine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9827 | INJECTION, SOLUTION | 5 mg | PERINEURAL | ANDA | 19 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 | 0404-9906 | INJECTION, SOLUTION | 2.50 mg | EPIDURAL | NDA | 16 sections |
| Marcaine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9906 | INJECTION, SOLUTION | 2.50 mg | EPIDURAL | NDA | 16 sections |
| Marcaine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9906 | INJECTION, SOLUTION | 2.50 mg | EPIDURAL | NDA | 16 sections |
| Marcaine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9907 | INJECTION, SOLUTION | 5 mg | EPIDURAL | NDA | 17 sections |
| Marcaine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9907 | INJECTION, SOLUTION | 5 mg | EPIDURAL | NDA | 17 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 | 19 sections |
| MARCAINE WITH EPINEPHRINE | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0404-9908 | INJECTION, SOLUTION | 2.50 mg | INFILTRATION | NDA | 19 sections |
| Sensorcaine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9945 | INJECTION, SOLUTION | 2.50 mg | INFILTRATION | NDA | 10 sections |
| Sensorcaine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9945 | INJECTION, SOLUTION | 2.50 mg | INFILTRATION | NDA | 10 sections |
| Sensorcaine MPF | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9946 | INJECTION, SOLUTION | 5 mg | PERINEURAL | ANDA | 11 sections |