Application 065386
- Type
- ANDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | No | No |
| 002 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | No | No |
| 003 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065386-001 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | ||
| A065386-002 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | ||
| A065386-003 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065386-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065386-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065386-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 2009-09-15 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-09-15 20:21 UTC | 2019-09 | A065386-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065386-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065386-003 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065386-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065386-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065386-003 | AP | 1 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Piperacillin and Tazobactam | PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM | Fresenius Kabi USA, LLC | e53ebafc-3afa-4a1e-9313-fecd1c1c5d7c | 2024-10-16 | Boxed warning, Warnings, Adverse reactions | Piperacillin and Tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN SODIUM,TAZOBACTAM SODIUM | Fresenius Kabi USA, LLC | ba87ade3-4d41-40c0-9f6a-27e121a4136d | 2024-10-16 | Warnings, Adverse reactions | Piperacillin and Tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM | Fresenius Kabi USA, LLC | 2cfa6723-175b-4c4d-8212-266844b07610 | 2024-10-16 | Boxed warning, Warnings, Adverse reactions | Piperacillin and Tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM | Fresenius Kabi USA, LLC | c78e0931-ec79-58e5-8658-7fe692dc3b8b | 2024-10-16 | Boxed warning, Warnings, Adverse reactions | Piperacillin and Tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN AND TAZOBACTAM | Apotex Corp. | c18109cf-d5db-4cc1-83da-537c8ab0e05c | 2024-10-14 | Warnings, Adverse reactions | Piperacillin and Tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN AND TAZOBACTAM | Shandong Anxin Pharmaceutical Co., Ltd. | f817b9be-b12b-48ac-8e4e-57ef6812eb32 | 2024-10-14 | Warnings, Adverse reactions | Piperacillin and Tazobactam |
| piperacillin and tazobactam | PIPERACILLIN AND TAZOBACTAM | Armas Pharmaceuticals Inc. | 24d9b4f1-109c-4db4-8a99-03afff045b47 | 2024-09-27 | Warnings, Adverse reactions | piperacillin and tazobactam |
| piperacillin and tazobactam | PIPERACILLIN AND TAZOBACTAM | Armas Pharmaceuticals Inc. | bbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a | 2024-09-27 | Warnings, Adverse reactions | piperacillin and tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM | Eugia US LLC | 80f4bdb8-131e-4485-b7a2-accd596d4cde | 2024-09-04 | Warnings, Adverse reactions | Piperacillin and Tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN AND TAZOBACTAM | Sandoz Inc | b1cb1314-d3e0-4b44-a1df-de14c32e8cc6 | 2024-08-23 | Warnings, Adverse reactions | Piperacillin and Tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN AND TAZOBACTAM | Hospira, Inc | 5e8bbfcd-3618-43ed-a158-9d524426fdc5 | 2024-08-23 | Warnings, Adverse reactions | Piperacillin and Tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN AND TAZOBACTAM | Fresenius Kabi USA, LLC | dc8208ea-a632-4291-a90b-2eba9a33bb40 | 2022-10-27 | Warnings, Adverse reactions | Piperacillin and Tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN AND TAZOBACTAM | Fresenius Kabi USA, LLC | b9bd733c-1176-42cb-b318-1223b7e48dcb | 2021-05-19 | Warnings, Adverse reactions | Piperacillin and Tazobactam |
| Piperacillin and Tazobactam | PIPERACILLIN AND TAZOBACTAM | Fresenius Kabi USA, LLC | 1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16 | 2021-04-02 | Warnings, Adverse reactions | Piperacillin and Tazobactam |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-0687 | Piperacillin and Tazobactam | PIPERACILLIN and TAZOBACTAM | Apotex Corporation | ANDA | Current |
| 60505-0687 | Piperacillin and Tazobactam | PIPERACILLIN and TAZOBACTAM | Apotex Corporation | ANDA | Current |
| 60505-0688 | Piperacillin and Tazobactam | PIPERACILLIN and TAZOBACTAM | Apotex Corporation | ANDA | Current |