tazobactam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
beta-lactamase inhibitors	2572	89786-04-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: tazobactam tazobactam sodium YTR-830 YTR 830	A penicillanic acid and sulfone derivative and potent BETA-LACTAMASE inhibitor that enhances the activity of other anti-bacterial agents against beta-lactamase producing bacteria. Molecular weight: 300.29 Formula: C10H12N4O5S CLOGP: -0.65 LIPINSKI: 0 HAC: 9 HDO: 1 TPSA: 122.46 ALOGS: -1.50 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

tazobactam
tazobactam sodium
YTR-830
YTR 830

A penicillanic acid and sulfone derivative and potent BETA-LACTAMASE inhibitor that enhances the activity of other anti-bacterial agents against beta-lactamase producing bacteria.

Molecular weight: 300.29
Formula: C10H12N4O5S
CLOGP: -0.65
LIPINSKI: 0
HAC: 9
HDO: 1
TPSA: 122.46
ALOGS: -1.50
ROTB: 3

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)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	77 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	66.49 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	0.26 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	4.81 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.70 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.97 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Oct. 22, 1993	FDA

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
Thrombocytopenia	105.21	18.96	114	7794	127559	50469657
Sepsis	75.19	18.96	98	7810	132827	50464389
Pyrexia	66.79	18.96	168	7740	380035	50217181
Acute kidney injury	65.49	18.96	123	7785	227935	50369281
Respiratory failure	59.10	18.96	72	7836	91109	50506107
Eosinophilia	54.98	18.96	35	7873	18617	50578599
Multiple organ dysfunction syndrome	54.20	18.96	52	7856	50285	50546931
Pancytopenia	53.88	18.96	66	7842	83964	50513252
Leukopenia	51.53	18.96	58	7850	67470	50529746
Renal failure	50.23	18.96	72	7836	106561	50490655
Toxic epidermal necrolysis	48.85	18.96	34	7874	20958	50576258
Dermatitis exfoliative generalised	47.43	18.96	18	7890	3108	50594108
Septic shock	45.15	18.96	50	7858	57125	50540091
Rash maculo-papular	43.74	18.96	35	7873	26606	50570610
Disseminated intravascular coagulation	40.44	18.96	28	7880	17107	50580109
Platelet count decreased	38.87	18.96	62	7846	100664	50496552
Tubulointerstitial nephritis	38.61	18.96	26	7882	15185	50582031
Rash morbilliform	34.75	18.96	14	7894	2832	50594384
Arthralgia	34.14	18.96	13	7895	438689	50158527
Haemoglobin decreased	32.01	18.96	65	7843	127151	50470065
Pleural effusion	31.23	18.96	50	7858	81404	50515812
Heparin-induced thrombocytopenia	30.28	18.96	14	7894	3951	50593265
Fatigue	30.22	18.96	40	7868	707561	49889655
Drug reaction with eosinophilia and systemic symptoms	29.89	18.96	29	7879	28395	50568821
Agranulocytosis	28.64	18.96	25	7883	21396	50575820
Nephropathy toxic	28.58	18.96	17	7891	8012	50589204
Toxic skin eruption	28	18.96	19	7889	11232	50585984
Pseudomonal sepsis	27.93	18.96	11	7897	2096	50595120
Drug ineffective	26.90	18.96	55	7853	819278	49777938
Acute generalised exanthematous pustulosis	26.90	18.96	17	7891	8921	50588295
Linear IgA disease	25.64	18.96	9	7899	1245	50595971
Joint swelling	25.37	18.96	4	7904	245282	50351934
Prothrombin time prolonged	24.59	18.96	16	7892	8822	50588394
Headache	24.39	18.96	26	7882	506509	50090707
Drug intolerance	24.00	18.96	3	7905	219101	50378115
Platelet count increased	23.64	18.96	19	7889	14521	50582695
Alopecia	23.18	18.96	5	7903	245042	50352174
Aspergillus infection	23.13	18.96	14	7894	6807	50590409
White blood cell count decreased	22.93	18.96	54	7854	116668	50480548
Fall	22.77	18.96	12	7896	334920	50262296
Neutropenia	22.37	18.96	62	7846	147903	50449313
Leukocytosis	21.81	18.96	22	7886	22557	50574659
Blood creatinine increased	21.67	18.96	41	7867	76119	50521097
Haemolytic anaemia	21.49	18.96	15	7893	9277	50587939
Abdominal discomfort	21.36	18.96	5	7903	231636	50365580
Dizziness	21.30	18.96	14	7894	346355	50250861
Hypokalaemia	20.99	18.96	44	7864	87948	50509268
Acinetobacter infection	20.87	18.96	8	7900	1419	50595797
Stevens-Johnson syndrome	20.66	18.96	21	7887	21731	50575485
Product contamination microbial	20.17	18.96	5	7903	205	50597011
Febrile neutropenia	20.07	18.96	46	7862	97621	50499595
Brain oedema	19.76	18.96	16	7892	12354	50584862
Streptococcal infection	19.41	18.96	11	7897	4737	50592479
Anaemia	19.06	18.96	84	7824	252372	50344844

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
Tubulointerstitial nephritis	96.68	17.12	66	10290	17577	29546594
Acute kidney injury	95.67	17.12	254	10102	265013	29299158
Thrombocytopenia	84.35	17.12	161	10195	134662	29429509
Sepsis	79.14	17.12	162	10194	142520	29421651
Pyrexia	69.19	17.12	239	10117	287383	29276788
Lymphocyte count abnormal	65.99	17.12	19	10337	608	29563563
Multiple organ dysfunction syndrome	58.70	17.12	90	10266	63026	29501145
Clostridial infection	46.87	17.12	23	10333	3292	29560879
Platelet count decreased	44.53	17.12	107	10249	104565	29459606
Disseminated intravascular coagulation	43.97	17.12	44	10312	19936	29544235
Agranulocytosis	41.50	17.12	43	10313	20297	29543874
Renal tubular necrosis	40.04	17.12	36	10320	14279	29549892
Rash	39.72	17.12	151	10205	189668	29374503
Stevens-Johnson syndrome	39.41	17.12	38	10318	16459	29547712
Septic shock	39.35	17.12	75	10281	62485	29501686
Neutropenia	38.28	17.12	117	10239	131594	29432577
Drug reaction with eosinophilia and systemic symptoms	38.13	17.12	48	10308	27944	29536227
Dizziness	35.79	17.12	11	10345	189673	29374498
Cholestasis	34.80	17.12	42	10314	23420	29540751
Choroiditis	34.50	17.12	13	10343	975	29563196
Respiratory failure	32.73	17.12	91	10265	97040	29467131
Nephropathy toxic	31.97	17.12	28	10328	10728	29553443
Renal failure	31.36	17.12	102	10254	118497	29445674
Clostridium difficile colitis	30.74	17.12	30	10326	13182	29550989
Heparin-induced thrombocytopenia	30.56	17.12	20	10336	4959	29559212
Congenital pneumonia	29.98	17.12	7	10349	95	29564076
Blood creatinine increased	29.92	17.12	81	10275	85021	29479150
Eosinophilia	25.52	17.12	35	10321	22126	29542045
Pneumonia staphylococcal	24.28	17.12	14	10342	2771	29561400
Fatigue	23.77	17.12	47	10309	316774	29247397
Transplant rejection	23.48	17.12	22	10334	9190	29554981
Alanine aminotransferase increased	23.41	17.12	66	10290	70878	29493293
Subclavian artery occlusion	23.38	17.12	6	10350	123	29564048
Neutrophil count increased	22.86	17.12	27	10329	14715	29549456
Spontaneous haematoma	22.80	17.12	8	10348	489	29563682
Hepatic failure	22.59	17.12	40	10316	31472	29532699
Chills	22.24	17.12	65	10291	71235	29492936
Aspartate aminotransferase increased	22.14	17.12	58	10298	59667	29504504
Haemodialysis	22.04	17.12	22	10334	9932	29554239
Leukopenia	21.90	17.12	55	10301	55148	29509023
Blood alkaline phosphatase increased	21.59	17.12	37	10319	28369	29535802
Dialysis	21.57	17.12	22	10334	10186	29553985
Pancytopenia	21.48	17.12	71	10285	83097	29481074
Lymphocyte count	21.48	17.12	5	10351	67	29564104
Death	21.41	17.12	56	10300	342028	29222143
Headache	21.07	17.12	18	10338	173989	29390182
Rash erythematous	20.36	17.12	31	10325	21531	29542640
Organ failure	20.34	17.12	11	10345	1925	29562246
Acute respiratory distress syndrome	20.30	17.12	32	10324	22903	29541268
Autoimmune haemolytic anaemia	20.13	17.12	14	10342	3834	29560337
Drug eruption	20.12	17.12	27	10329	16714	29547457
Hepatic function abnormal	19.82	17.12	43	10313	39216	29524955
Blood bilirubin increased	19.30	17.12	39	10317	33854	29530317
Gamma-glutamyltransferase increased	19.24	17.12	34	10322	26703	29537468
Rash maculo-papular	18.93	17.12	32	10324	24257	29539914
Anaphylactic reaction	18.49	17.12	34	10322	27539	29536632
Respiratory distress	18.35	17.12	37	10319	32069	29532102
Dermatitis exfoliative	17.65	17.12	16	10340	6409	29557762
Intraocular pressure increased	17.39	17.12	14	10342	4775	29559396

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
Acute kidney injury	153.04	16.76	327	14621	448913	64034871
Thrombocytopenia	137.79	16.76	211	14737	223590	64260194
Tubulointerstitial nephritis	122.81	16.76	81	14867	30828	64452956
Sepsis	114.30	16.76	197	14751	230144	64253640
Pyrexia	94.81	16.76	314	14634	558330	63925454
Multiple organ dysfunction syndrome	81.98	16.76	109	14839	101304	64382480
Septic shock	81.68	16.76	111	14837	105326	64378458
Renal failure	78.00	16.76	146	14802	181542	64302242
Eosinophilia	73.73	16.76	65	14883	38011	64445773
Drug reaction with eosinophilia and systemic symptoms	66.38	16.76	72	14876	54145	64429639
Clostridial infection	61.73	16.76	28	14920	5091	64478693
Fatigue	59.36	16.76	52	14896	748678	63735106
Rash maculo-papular	58.52	16.76	63	14885	46963	64436821
Agranulocytosis	58.04	16.76	57	14891	38172	64445612
Nephropathy toxic	55.62	16.76	40	14908	17474	64466310
Respiratory failure	55.30	16.76	118	14830	161065	64322719
Heparin-induced thrombocytopenia	53.76	16.76	30	14918	8449	64475335
Dizziness	52.85	16.76	17	14931	430146	64053638
Pancytopenia	51.57	16.76	107	14841	143202	64340582
Platelet count decreased	51.01	16.76	117	14831	167594	64316190
Leukopenia	50.61	16.76	87	14861	101155	64382629
Disseminated intravascular coagulation	50.54	16.76	49	14899	32299	64451485
Stevens-Johnson syndrome	50.02	16.76	50	14898	34199	64449585
Arthralgia	48.43	16.76	21	14927	442239	64041545
Transplant rejection	46.87	16.76	36	14912	17365	64466419
Renal tubular necrosis	45.32	16.76	39	14909	22071	64461713
Neutropenia	44.30	16.76	139	14809	239485	64244299
Headache	44.06	16.76	35	14913	529432	63954352
Toxic epidermal necrolysis	43.12	16.76	48	14900	37118	64446666
Clostridium difficile colitis	40.22	16.76	40	14908	27183	64456601
Acute generalised exanthematous pustulosis	39.88	16.76	30	14918	14028	64469756
Choroiditis	38.52	16.76	13	14935	1074	64482710
Dialysis	37.04	16.76	31	14917	16889	64466895
Rash	36.95	16.76	206	14742	458343	64025441
Fall	36.65	16.76	26	14922	416800	64066984
Joint swelling	35.89	16.76	4	14944	215378	64268406
Cholestasis	32.84	16.76	46	14902	44826	64438958
Autoimmune haemolytic anaemia	31.67	16.76	20	14928	7056	64476728
Toxic skin eruption	31.61	16.76	30	14918	19254	64464530
Blood creatinine increased	31.03	16.76	85	14863	135697	64348087
Weight increased	30.85	16.76	6	14942	213342	64270442
Acute respiratory distress syndrome	30.12	16.76	41	14907	38894	64444890
Hypotension	29.89	16.76	170	14778	380804	64102980
Dermatitis exfoliative generalised	29.73	16.76	18	14930	5898	64477886
Nasopharyngitis	29.46	16.76	5	14943	196068	64287716
Prothrombin time prolonged	28.73	16.76	26	14922	15715	64468069
Drug intolerance	27.79	16.76	5	14943	187987	64295797
Alopecia	27.79	16.76	3	14945	165687	64318097
Haemodialysis	26.92	16.76	26	14922	17051	64466733
Linear IgA disease	26.74	16.76	13	14935	2761	64481023
Systemic candida	26.23	16.76	16	14932	5313	64478471
Nephritis	26.16	16.76	14	14934	3632	64480152
Blood bilirubin increased	25.57	16.76	47	14901	57506	64426278
Anaphylactic reaction	25.53	16.76	52	14896	68612	64415172
Haemoglobin decreased	25.50	16.76	101	14847	194962	64288822
Enterococcal infection	25.49	16.76	23	14925	13843	64469941
Acinetobacter infection	25.28	16.76	12	14936	2417	64481367
Interstitial lung disease	25.19	16.76	64	14884	97668	64386116
Blood alkaline phosphatase increased	25.06	16.76	46	14902	56233	64427551
Renal impairment	24.61	16.76	78	14870	134939	64348845
Aspartate aminotransferase increased	24.44	16.76	72	14876	119716	64364068
Subclavian artery occlusion	24.37	16.76	6	14942	159	64483625
Rash morbilliform	24.19	16.76	15	14933	5126	64478658
Neutrophil count decreased	23.59	16.76	54	14894	77142	64406642
Weight decreased	23.57	16.76	19	14929	285720	64198064
White blood cell count decreased	23.33	16.76	85	14863	157752	64326032
Respiratory distress	22.33	16.76	42	14906	52289	64431495
Pseudomembranous colitis	22.27	16.76	14	14934	4902	64478882
Rash erythematous	21.96	16.76	40	14908	48593	64435191
Pain in extremity	21.64	16.76	23	14925	303062	64180722
Petechiae	21.50	16.76	24	14924	18602	64465182
Alanine aminotransferase increased	21.50	16.76	76	14872	138955	64344829
Febrile neutropenia	21.26	16.76	93	14855	187564	64296220
Neutrophilic dermatosis	21.11	16.76	7	14941	548	64483236
Abdominal discomfort	20.98	16.76	8	14940	182314	64301470
Staphylococcal infection	20.79	16.76	40	14908	50638	64433146
Dermatitis exfoliative	20.68	16.76	18	14930	10334	64473450
Hepatic failure	20.65	16.76	42	14906	55352	64428432
Pseudomonas infection	20.57	16.76	23	14925	17860	64465924
Antibiotic level above therapeutic	20.43	16.76	7	14941	606	64483178
Aplasia pure red cell	19.97	16.76	15	14933	6999	64476785
Hepatic cytolysis	19.57	16.76	20	14928	14029	64469755
International normalised ratio increased	19.52	16.76	51	14897	79116	64404668
Pleural effusion	19.41	16.76	69	14879	126490	64357294
Extravasation blood	19.28	16.76	6	14942	383	64483401
Acanthosis	19.03	16.76	6	14942	400	64483384
White blood cell count increased	18.88	16.76	45	14903	65969	64417815
Aspergillus infection	18.73	16.76	21	14927	16358	64467426
Spontaneous haematoma	18.71	16.76	8	14940	1263	64482521
Hepatic function abnormal	18.56	16.76	44	14904	64269	64419515
Drug abuse	18.55	16.76	4	14944	132370	64351414
Blood culture positive	18.44	16.76	15	14933	7853	64475931
Muscle spasms	18.32	16.76	5	14943	141018	64342766
Leukocytosis	18.27	16.76	32	14916	37708	64446076
Organ failure	18.11	16.76	11	14937	3622	64480162
Clostridium difficile infection	17.95	16.76	31	14917	36132	64447652
Purpura	17.85	16.76	21	14927	17225	64466559
Insomnia	17.80	16.76	12	14936	197824	64285960
Skin oedema	17.71	16.76	8	14940	1440	64482344
Neuralgic amyotrophy	17.55	16.76	5	14943	235	64483549
Moraxella infection	17.48	16.76	6	14942	522	64483262
Haemolytic anaemia	17.37	16.76	20	14928	16033	64467751
Contusion	16.91	16.76	3	14945	113962	64369822
Klebsiella infection	16.88	16.76	18	14930	13263	64470521

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J01CG02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE BETA-LACTAM ANTIBACTERIALS, PENICILLINS Beta-lactamase inhibitors
FDA MoA	N0000000202	beta Lactamase Inhibitors
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D065093	beta-Lactamase Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
CHEBI has role	CHEBI:33281	antibiotics
CHEBI has role	CHEBI:35441	antiinfective agents
CHEBI has role	CHEBI:35625	beta-lactamase inhibitors
FDA EPC	N0000175930	beta Lactamase Inhibitor

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

Disease	Relation	SNOMED_ID	DOID
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Abscess of liver	indication	27916005
Peritonitis	indication	48661000
Bacterial pneumonia	indication	53084003	DOID:874
Haemophilus influenzae pneumonia	indication	70036007
Appendicitis	indication	74400008	DOID:8337
Abdominal abscess	indication	75100008
Cholecystitis	indication	76581006	DOID:1949
Infection due to Staphylococcus aureus	indication	406602003
Bacterial cystitis	indication	424551004
Nosocomial pneumonia	indication	425464007
Sepsis caused by Haemophilus influenzae	indication	447685007
Sepsis caused by Serratia	indication	449084002
Bacterial pyelonephritis	indication	838353009
Complicated Skin and Skin Structure Staphylococcus Aureus Infection	indication
E. Coli Complicated Appendicitis	indication
Staphylococcus Nosocomial Pneumonia	indication
Diabetic Foot Infection	indication
Bacteroides Peritonitis	indication
E. Coli Endometritis	indication
E. Coli Appendicitis	indication
Inflammatory Disease of Female Pelvic Organs	indication
E. Coli Pelvic Inflammatory Disease	indication
Bacteroides Complicated Appendicitis	indication
Bacteroides Appendicitis	indication
Complicated Skin and Skin Structure Infection	indication
E. Coli Peritonitis	indication
Ecthyma gangrenosum	off-label use	17732003
Infection of bone	off-label use	111253001
Sepsis of the newborn	off-label use	206376005
Diverticulitis of gastrointestinal tract	off-label use	271366000
Pseudomonas Respiratory Tract Infection in Cystic Fibrosis	off-label use
Blood coagulation disorder	contraindication	64779008	DOID:1247
Kidney disease	contraindication	90708001	DOID:557
Infectious mononucleosis	contraindication	271558008	DOID:8568
Neutropenic disorder	contraindication	303011007	DOID:1227
Pseudomembranous enterocolitis	contraindication	397683000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.19	acidic
pKa2	0.39	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
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOSYN	WYETH PHARMS	N050684	Oct. 22, 1993	DISCN	INJECTABLE	INJECTION	6900184	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOSYN	WYETH PHARMS	N050684	Oct. 22, 1993	DISCN	INJECTABLE	INJECTION	8133883	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOSYN	WYETH PHARMS	N050684	Oct. 22, 1993	DISCN	INJECTABLE	INJECTION	6900184	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOSYN	WYETH PHARMS	N050684	Oct. 22, 1993	DISCN	INJECTABLE	INJECTION	8133883	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOSYN	WYETH PHARMS	N050684	Oct. 22, 1993	DISCN	INJECTABLE	INJECTION	6900184	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOSYN	WYETH PHARMS	N050684	Oct. 22, 1993	DISCN	INJECTABLE	INJECTION	8133883	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOSYN	WYETH PHARMS	N050684	Oct. 22, 1993	DISCN	INJECTABLE	INJECTION	6900184	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZOSYN	WYETH PHARMS	N050684	Oct. 22, 1993	DISCN	INJECTABLE	INJECTION	8133883	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 40MG BASE/ML;EQ 5MG BASE/ML	ZOSYN IN PLASTIC CONTAINER	WYETH PHARMS	N050750	Feb. 24, 1998	RX	INJECTABLE	INJECTION	6900184	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 40MG BASE/ML;EQ 5MG BASE/ML	ZOSYN IN PLASTIC CONTAINER	WYETH PHARMS	N050750	Feb. 24, 1998	RX	INJECTABLE	INJECTION	8133883	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	ZOSYN IN PLASTIC CONTAINER	WYETH PHARMS	N050750	Feb. 24, 1998	RX	INJECTABLE	INJECTION	6900184	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	ZOSYN IN PLASTIC CONTAINER	WYETH PHARMS	N050750	Feb. 24, 1998	RX	INJECTABLE	INJECTION	8133883	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	ZOSYN IN PLASTIC CONTAINER	WYETH PHARMS	N050750	Feb. 24, 1998	RX	INJECTABLE	INJECTION	6900184	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	ZOSYN IN PLASTIC CONTAINER	WYETH PHARMS	N050750	Feb. 24, 1998	RX	INJECTABLE	INJECTION	8133883	April 14, 2023	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	7129232	May 15, 2028	COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	7129232	May 15, 2028	COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	7129232	May 15, 2028	METHODS FOR TREATING BACTERIAL INFECTIONS
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	7129232	May 15, 2028	METHODS OF TREATING BACTERIAL ILLNESSES
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10028963	Sept. 7, 2032	TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10028963	Sept. 7, 2032	TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	9724353	Sept. 7, 2032	TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	9724353	Sept. 7, 2032	TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	8685957	Sept. 27, 2032	METHODS OF TREATING BACTERIAL ILLNESSES
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10420841	March 14, 2034	COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10420841	March 14, 2034	COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10420841	March 14, 2034	TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10420841	March 14, 2034	TREATMENT OF COMPLICATED URINARY TRACT INFECTION
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	11278622	March 14, 2034	TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA (HABP)
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	11278622	March 14, 2034	TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (VABP)
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	8968753	March 14, 2034	COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	8968753	March 14, 2034	COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	8968753	March 14, 2034	TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	8968753	March 14, 2034	TREATMENT OF COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10376496	Sept. 9, 2034	TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10376496	Sept. 9, 2034	TREATMENT OF COMPLICATED URINARY TRACT INFECTION IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10933053	Sept. 9, 2034	TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10933053	Sept. 9, 2034	TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	Dec. 19, 2019	NEW CHEMICAL ENTITY
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	Dec. 19, 2024	GENERATING ANTIBIOTIC INCENTIVES NOW
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	April 21, 2025	NEW PATIENT POPULATION

Bioactivity Summary:

Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-lactamase TEM	Enzyme	BLAT_ECOLX	INHIBITOR	IC50	6.60	WOMBAT-PK	CHEMBL
Beta-lactamase	Enzyme	BLAC_STAAU		IC50	6.53	WOMBAT-PK
Beta-lactamase	Enzyme	AMPC_ECOLI		IC50	7.82	WOMBAT-PK
Beta-lactamase	Enzyme	Q59401_ENTCL		IC50	5.47	CHEMBL
Beta-lactamase SHV-1	Enzyme	BLA1_ECOLX		IC50	6.65	CHEMBL
Beta-lactamase 1	Enzyme	BLA1_BACCE		IC50	6.52	DRUG MATRIX
IMI-1; IMI-1 carbapenemase	Enzyme	Q46991_ENTCL		IC50	7.52	CHEMBL
Beta-lactamase	Enzyme	AMPC_ENTCL		IC50	7	CHEMBL
Beta-lactamase	Enzyme	Q6W9J1_ENTCL		IC50	7.22	CHEMBL
Beta-lactamase	Enzyme	AMPC_PSEAE		IC50	6.09	CHEMBL
Beta-lactamase	Enzyme	AMPC_MORMO		IC50	6.72	CHEMBL
Beta-lactamase	Enzyme	AMPC_CITFR		IC50	6.03	CHEMBL
Beta-lactamase	Enzyme	A4KCT8_9ENTR		IC50	7.40	CHEMBL
Beta-lactamase	Enzyme	A1E3K9_ECOLX		IC50	8	CHEMBL
Beta-lactamase	Enzyme	A8RR46_BACCS		IC50	8.40	CHEMBL
Carbapenem-hydrolizing beta-lactamase SFC-1	Enzyme	Q6JP75_SERFO		IC50	5.16	CHEMBL
Carbepenem-hydrolyzing beta-lactamase KPC	Enzyme	BLKPC_KLEPN		Ki	4.13	CHEMBL
Beta-lactamase	Enzyme	A2RP81_CITFR		IC50	7.02	CHEMBL
Beta-lactamase	Enzyme	Q9EXV5_ECOLX		IC50	8.70	CHEMBL
Beta-lactamase SHV-1	Enzyme	BLA1_KLEPN		IC50	6.96	CHEMBL
Beta-lactamase	Enzyme	Q6GWS8_ECOLX		IC50	6.62	CHEMBL
Beta-lactamase GES-13	Enzyme	D1MIX9_PSEAI		IC50	7.22	CHEMBL
Beta-lactamase	Enzyme	A0ZX81_KLEPN		IC50	7.10	CHEMBL
Class D beta-lactamase	Unclassified	Q50H31_BRAPL		IC50	6.80	CHEMBL
Beta-lactamase	Enzyme	B8R6A5_9BURK		IC50	6.30	CHEMBL
Beta-lactamase	Enzyme	Q2XPY6_SALET		IC50	8.66	CHEMBL
Beta-lactamase	Enzyme	D2SSQ3_PSEAI		IC50	5.70	CHEMBL
Beta-lactamase	Enzyme	Q3SAW3_PSEAI		IC50	5.70	CHEMBL
Beta-lactamase	Enzyme	BLAC_BACLI		IC50	6.29	CHEMBL
Beta-lactamase	Enzyme	Q670S6_PSELU		IC50	7.40	CHEMBL

External reference:

ID	Source
D00660	KEGG_DRUG
89785-84-2	SECONDARY_CAS_RN
4020843	VANDF
C0075870	UMLSCUI
CHEBI:9421	CHEBI
TAZ	PDB_CHEM_ID
CHEMBL404	ChEMBL_ID
DB01606	DRUGBANK_ID
CHEMBL1439	ChEMBL_ID
D000078142	MESH_DESCRIPTOR_UI
123630	PUBCHEM_CID
10789	IUPHAR_LIGAND_ID
6340	INN_ID
SE10G96M8W	UNII
221167	RXNORM
30782	MMSL
5543	MMSL
d04404	MMSL
004398	NDDF
004399	NDDF
410931003	SNOMEDCT_US
427652008	SNOMEDCT_US
96007008	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Zosyn in Galaxy Containers	HUMAN PRESCRIPTION DRUG LABEL	2	0206-8860	INJECTION, SOLUTION	250 mg	INTRAVENOUS	NDA	27 sections
Zosyn in Galaxy Containers	HUMAN PRESCRIPTION DRUG LABEL	2	0206-8860	INJECTION, SOLUTION	250 mg	INTRAVENOUS	NDA	27 sections
Zosyn in Galaxy Containers	HUMAN PRESCRIPTION DRUG LABEL	2	0206-8861	INJECTION, SOLUTION	375 mg	INTRAVENOUS	NDA	27 sections
Zosyn in Galaxy Containers	HUMAN PRESCRIPTION DRUG LABEL	2	0206-8861	INJECTION, SOLUTION	375 mg	INTRAVENOUS	NDA	27 sections
Zosyn in Galaxy Containers	HUMAN PRESCRIPTION DRUG LABEL	2	0206-8862	INJECTION, SOLUTION	500 mg	INTRAVENOUS	NDA	27 sections
Zosyn in Galaxy Containers	HUMAN PRESCRIPTION DRUG LABEL	2	0206-8862	INJECTION, SOLUTION	500 mg	INTRAVENOUS	NDA	27 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0409-2999	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1.50 g	INTRAVENOUS	ANDA	25 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0409-3374	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.25 g	INTRAVENOUS	ANDA	25 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0409-3378	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.38 g	INTRAVENOUS	ANDA	25 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0409-3379	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 g	INTRAVENOUS	ANDA	25 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0409-3383	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.25 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0409-3385	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.38 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0409-3390	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0781-3110	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.25 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0781-3113	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.38 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0781-3114	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0781-3117	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1.50 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0781-3180	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	4.50 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0781-9210	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.25 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0781-9213	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.38 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	0781-9214	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	22607-012	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	22607-034	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.25 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	22607-056	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.38 g	INTRAVENOUS	ANDA	26 sections
Piperacillin and Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	22607-679	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	4.50 g	INTRAVENOUS	ANDA	26 sections
Piperacillin, Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	25021-164	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.25 g	INTRAVENOUS	ANDA	30 sections
Piperacillin, Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	25021-165	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.38 g	INTRAVENOUS	ANDA	30 sections
Piperacillin, Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	25021-166	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 g	INTRAVENOUS	ANDA	30 sections
Piperacillin, Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	25021-175	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.25 g	INTRAVENOUS	ANDA	30 sections
Piperacillin, Tazobactam	HUMAN PRESCRIPTION DRUG LABEL	2	25021-176	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.38 g	INTRAVENOUS	ANDA	30 sections