Piperacillin / tazobactam Injectable Solution
- Brand(s)
- Zosyn
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Wyeth Pharmaceuticals, Inc. (2015-10-28)
- Oldest Current Product
- 1993-11-01
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\PIPERACILLIN:TAZOBACTAM
- FDAOB
- INJECTION\INJECTION\PIPERACILLIN SODIUM: TAZOBACTAM SODIUM\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PIPERACILLIN SODIUM: TAZOBACTAM SODIUM
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PIPERACILLIN SODIUM: TAZOBACTAM SODIUM - SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PIPERACILLIN ANHYDROUS: TAZOBACTAM
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PIPERACILLIN ANHYDROUS: TAZOBACTAM
product(s) by strength(s)
piperacillin 200 mg/ml / tazobactam 25 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 002065501 | Zosyn | NDA | Wyeth Pharmaceuticals, Inc. | 2013-06-01 | PIPERACILLIN SODIUM, TAZOBACTAM SODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA050684 | 81b0bb45-ce9d-43e7-b181-64315e14be55, c08f0339-d24b-43c1-931b-77a36b120dfa |
| 2 | 002068859 | Zosyn | NDA | Wyeth Pharmaceuticals, Inc. | 1993-11-01 | PIPERACILLIN SODIUM, TAZOBACTAM SODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA050684 | e103a5e4-1d0b-4e1f-c69b-774f6ab70df1 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 445670804 | ANDA | Wg Critical Care, Llc | 2009-10-20 | PIPERACILLIN SODIUM, TAZOBACTAM SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA090498 | 17a400ae-cbaa-4d07-95f4-c6917dfc0585 |
| 2 | 605050773 | ANDA | Apotex Corp | 2009-10-05 | PIPERACILLIN SODIUM, TAZOBACTAM SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA065446 | 7b3ba6b9-59e1-454a-9ddc-ab3592221627 |
| 3 | 633230304 | ANDA | App Pharmaceuticals, Llc | 2011-05-31 | PIPERACILLIN SODIUM, TAZOBACTAM SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA090498 | 2cfa6723-175b-4c4d-8212-266844b07610, c78e0931-ec79-58e5-8658-7fe692dc3b8b, e53ebafc-3afa-4a1e-9313-fecd1c1c5d7c |
application(s)
| # | id | title | applicant | approved | patent | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA065362 | PIPERACILLIN AND TAZOBACTAM | SANDOZ INC | 2010-10-21 | ANDA065362_001, ANDA065362_002, ANDA065362_003 | Piperacillin / tazobactam Injection | |
| 2 | ANDA065363 | PIPERACILLIN AND TAZOBACTAM | SANDOZ INC | 2010-10-21 | ANDA065363_001, ANDA065363_002, ANDA065363_003 | Piperacillin / tazobactam Injection | |
| 3 | ANDA065386 | PIPERACILLIN AND TAZOBACTAM | HOSPIRA INC | 2009-09-15 | ANDA065386_001, ANDA065386_002, ANDA065386_003 | Piperacillin / tazobactam Injection | |
| 4 | ANDA065446 | PIPERACILLIN AND TAZOBACTAM | HOSPIRA INC | 2009-09-15 | ANDA065446_001 | Piperacillin / tazobactam Injection | |
| 5 | ANDA065458 | PIPERACILLIN AND TAZOBACTAM | MYLAN LABORATORIES LTD | 2014-08-15 | ANDA065458_001, ANDA065458_002, ANDA065458_003 | Piperacillin / tazobactam Injection | |
| 6 | ANDA065498 | PIPERACILLIN AND TAZOBACTAM | AUROBINDO PHARMA LTD | 2011-05-23 | ANDA065498_001, ANDA065498_002, ANDA065498_003 | Piperacillin / tazobactam Injection | |
| 7 | ANDA065523 | PIPERACILLIN AND TAZOBACTAM | ISTITUTO BIOCHIMICO ITALIANO SPA | 2011-05-31 | ANDA065523_001, ANDA065523_002, ANDA065523_003 | Piperacillin / tazobactam Injection | |
| 8 | ANDA090498 | PIPERACILLIN AND TAZOBACTAM | ISTITUTO BIOCHIMICO ITALIANO SPA | 2011-05-31 | ANDA090498_001 | Piperacillin / tazobactam Injection | |
| 9 | NDA050684 | ZOSYN | WYETH PHARMACEUTICALS INC | 1993-10-22 | p6900184, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE p8133883, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE p7915229, SUBSTANCE | NDA050684_001, NDA050684_002, NDA050684_003, NDA050684_004 | Piperacillin / tazobactam Injection |
| 10 | NDA050750 | ZOSYN IN PLASTIC CONTAINER | WYETH PHARMACEUTICALS INC | 1998-02-24 | p6207661, SUBSTANCE p6900184, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE p8133883, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE p7915229, SUBSTANCE | NDA050750_001, NDA050750_002, NDA050750_003 | Piperacillin / tazobactam Injection |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA065362_001 | RX | TAZOBACTAM SODIUM (EQ 250MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | AP | 2010-10-21 | PIPERACILLIN AND TAZOBACTAM |
| 2 | ANDA065362_002 | RX | TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 3GM BASE/VIAL) | INJECTION | False | AP | 2010-10-21 | PIPERACILLIN AND TAZOBACTAM |
| 3 | ANDA065362_003 | RX | PIPERACILLIN SODIUM (EQ 4GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | AP | 2010-10-21 | PIPERACILLIN AND TAZOBACTAM |
| 4 | ANDA065363_001 | RX | PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 250MG BASE/VIAL) | INJECTION | False | AP | 2010-10-21 | PIPERACILLIN AND TAZOBACTAM |
| 5 | ANDA065363_002 | RX | TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 3GM BASE/VIAL) | INJECTION | False | AP | 2010-10-21 | PIPERACILLIN AND TAZOBACTAM |
| 6 | ANDA065363_003 | RX | PIPERACILLIN SODIUM (EQ 4GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | AP | 2010-10-21 | PIPERACILLIN AND TAZOBACTAM |
| 7 | ANDA065386_001 | RX | PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 250MG BASE/VIAL) | INJECTION | False | AP | 2009-09-15 | PIPERACILLIN AND TAZOBACTAM |
| 8 | ANDA065386_002 | RX | PIPERACILLIN SODIUM (EQ 3GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL) | INJECTION | False | AP | 2009-09-15 | PIPERACILLIN AND TAZOBACTAM |
| 9 | ANDA065386_003 | RX | PIPERACILLIN SODIUM (EQ 4GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | AP | 2009-09-15 | PIPERACILLIN AND TAZOBACTAM |
| 10 | ANDA065446_001 | RX | PIPERACILLIN SODIUM (EQ 36GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 4.5GM BASE/VIAL) | INJECTION | False | AP | 2009-09-15 | PIPERACILLIN AND TAZOBACTAM |
| 11 | ANDA065458_001 | RX | TAZOBACTAM SODIUM (EQ 250MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | AP | 2014-08-15 | PIPERACILLIN AND TAZOBACTAM |
| 12 | ANDA065458_002 | RX | PIPERACILLIN SODIUM (EQ 3GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL) | INJECTION | False | AP | 2014-08-15 | PIPERACILLIN AND TAZOBACTAM |
| 13 | ANDA065458_003 | RX | TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 4GM BASE/VIAL) | INJECTION | False | AP | 2014-08-15 | PIPERACILLIN AND TAZOBACTAM |
| 14 | ANDA065498_001 | RX | TAZOBACTAM SODIUM (EQ 250MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | AP | 2011-05-23 | PIPERACILLIN AND TAZOBACTAM |
| 15 | ANDA065498_002 | RX | TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 3GM BASE/VIAL) | INJECTION | False | AP | 2011-05-23 | PIPERACILLIN AND TAZOBACTAM |
| 16 | ANDA065498_003 | RX | PIPERACILLIN SODIUM (EQ 4GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | AP | 2011-05-23 | PIPERACILLIN AND TAZOBACTAM |
| 17 | ANDA065523_001 | RX | PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 250MG BASE/VIAL) | INJECTION | False | AP | 2011-05-31 | PIPERACILLIN AND TAZOBACTAM |
| 18 | ANDA065523_002 | RX | PIPERACILLIN SODIUM (EQ 3GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL) | INJECTION | False | AP | 2011-05-31 | PIPERACILLIN AND TAZOBACTAM |
| 19 | ANDA065523_003 | RX | TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 4GM BASE/VIAL) | INJECTION | False | AP | 2011-05-31 | PIPERACILLIN AND TAZOBACTAM |
| 20 | ANDA090498_001 | RX | TAZOBACTAM SODIUM (EQ 4.5GM BASE/VIAL), PIPERACILLIN SODIUM (EQ 36GM BASE/VIAL) | INJECTION | False | AP | 2011-05-31 | PIPERACILLIN AND TAZOBACTAM |
| 21 | NDA050684_001 | RX | TAZOBACTAM SODIUM (EQ 250MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | True | AP | 1993-10-22 | ZOSYN |
| 22 | NDA050684_002 | RX | PIPERACILLIN SODIUM (EQ 3GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL) | INJECTION | True | AP | 1993-10-22 | ZOSYN |
| 23 | NDA050684_003 | RX | PIPERACILLIN SODIUM (EQ 4GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL) | INJECTION | True | AP | 1993-10-22 | ZOSYN |
| 24 | NDA050684_004 | RX | TAZOBACTAM SODIUM (EQ 4.5GM BASE/VIAL), PIPERACILLIN SODIUM (EQ 36GM BASE/VIAL) | INJECTION | True | AP | 1993-10-22 | ZOSYN |
| 25 | NDA050750_001 | RX | PIPERACILLIN SODIUM (EQ 40MG BASE/ML), TAZOBACTAM SODIUM (EQ 5MG BASE/ML) | INJECTION | True | 1998-02-24 | ZOSYN IN PLASTIC CONTAINER | |
| 26 | NDA050750_002 | RX | TAZOBACTAM SODIUM (EQ 7.5MG BASE/ML), PIPERACILLIN SODIUM (EQ 60MG BASE/ML) | INJECTION | True | 1998-02-24 | ZOSYN IN PLASTIC CONTAINER | |
| 27 | NDA050750_003 | RX | PIPERACILLIN SODIUM (EQ 4GM BASE/100ML), TAZOBACTAM SODIUM (EQ 500MG BASE/100ML) | INJECTION | True | 1998-02-24 | ZOSYN IN PLASTIC CONTAINER |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6207661 (view patent) | 2019-02-22 | NDA050750 | Piperacillin / tazobactam Injection |
| 2 | p6900184 (view patent) | 2023-04-14 | NDA050684, NDA050750 | Piperacillin / tazobactam Injection |
| 3 | p7915229 (view patent) | 2023-04-14 | NDA050684, NDA050750 | Piperacillin / tazobactam Injection |
| 4 | p8133883 (view patent) | 2023-04-14 | NDA050684, NDA050750 | Piperacillin / tazobactam Injection |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 11c039a1-c9c2-3f82-fcc8-fc7443e409e5 (view SPL) | These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN. ZOSYN (piperacillin/tazobactam) FOR INJECTION: single-dose and pharmacy bulk vials ZOSYN (piperacillin/tazobactam) INJECTION: single dose GALAXY containers Initial U.S. approval: 1993 | prescription | Human Prescription | Wyeth Pharmaceuticals, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-11-11 | 19 | 002062404, 002062405, 002062408, 002062409, 002062411, 002062413, 002062416 | Piperacillin / tazobactam Injection |
| 2 | 17a400ae-cbaa-4d07-95f4-c6917dfc0585 (view SPL) | These highlights do not include all the information needed to usePiperacillin and Tazobactam for Injection safely and effectively. See full prescribing information forPiperacillin and Tazobactam for Injection. Piperacillin and Tazobactam for Injection:pharmacy bulk package bottlesInitial U.S. Approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. | prescription | Human Prescription | Wg Critical Care, Llc | MANUFACTURE | 2014-01-01 | 3 | 445670804 | |
| 3 | 23b0efbd-88e6-a8eb-b954-67c3e16846ba (view SPL) | ZOSYN (Piperacillin and Tazobactam for Injection, USP) | prescription | Human Prescription | Wyeth Pharmaceuticals, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2012-09-20 | 10 | 002062416 | |
| 4 | 2cfa6723-175b-4c4d-8212-266844b07610 (view SPL) | These highlights do not include all the information needed to usePiperacillin and Tazobactam for Injection safely and effectively. See full prescribing information forPiperacillin and Tazobactam for Injection. Piperacillin and Tazobactam for Injection:pharmacy bulk package bottlesInitial U.S. Approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-06-12 | 1 | 633230304 | |
| 5 | 7b3ba6b9-59e1-454a-9ddc-ab3592221627 (view SPL) | These highlights do not include all the information needed to use Piperacillin and Tazobactam for Injection safely and effectively. See full prescribing information for Piperacillin and Tazobactam for Injection. Piperacillin and Tazobactam for Injection, USP: Pharmacy bulk vials Initial U.S. approval: 1993 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection, USP and other antibacterial drugs, Piperacillin and Tazobactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. | prescription | Human Prescription | Apotex Corp | 2015-09-07 | 7 | 605050773 | ||
| 6 | 81b0bb45-ce9d-43e7-b181-64315e14be55 (view SPL) | ZOSYN (Piperacillin and Tazobactam for Injection, USP) | prescription | Human Prescription | Wyeth Pharmaceuticals, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2013-11-06 | 2 | 002065501 | |
| 7 | c08f0339-d24b-43c1-931b-77a36b120dfa (view SPL) | These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN.ZOSYN (piperacillin/tazobactam) FOR INJECTION: single-dose and pharmacy bulk vialsInitial U.S. approval: 1993 | prescription | Human Prescription | Wyeth Pharmaceuticals, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-08-06 | 6 | 002065501, 002062501, 002063501, 002064501 | Piperacillin / tazobactam Injection |
| 8 | c78e0931-ec79-58e5-8658-7fe692dc3b8b (view SPL) | These highlights do not include all the information needed to usePiperacillin and Tazobactam for Injection safely and effectively. See full prescribing information forPiperacillin and Tazobactam for Injection. Piperacillin and Tazobactam for Injection:pharmacy bulk package bottlesInitial U.S. Approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2014-01-01 | 4 | 633230304 | |
| 9 | e103a5e4-1d0b-4e1f-c69b-774f6ab70df1 (view SPL) | These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN.ZOSYN (piperacillin/tazobactam) FOR INJECTION: single-dose and pharmacy bulk vialsZOSYN (piperacillin/tazobactam) INJECTION: single dose GALAXY containers Initial U.S. approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZOSYN and other antibacterial drugs, ZOSYN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. | prescription | Human Prescription | Wyeth Pharmaceuticals, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-10-28 | 19 | 002068859, 002068852, 002068854, 002068855, 002068860, 002068861, 002068862 | Piperacillin / tazobactam Injection |
| 10 | e53ebafc-3afa-4a1e-9313-fecd1c1c5d7c (view SPL) | These highlights do not include all the information needed to usePiperacillin and Tazobactam for Injection safely and effectively. See full prescribing information forPiperacillin and Tazobactam for Injection. Piperacillin and Tazobactam for Injection:pharmacy bulk package bottlesInitial U.S. Approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-06-12 | 1 | 633230304 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII