Piperacillin and Tazobactam
- Product NDC
- 0409-3390
- 11-digit product format
- 004093390
- Labeler code
- 0409
- Product ID
- 0409-3390_dc276e7f-fb47-4b2c-b732-cb22d050ea93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Piperacillin and Tazobactam
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; PARENTERAL
- Labeler
- Hospira, Inc
- Application
- ANDA065362
- Marketing category
- ANDA
- Marketing start
- 2010-10-21
- Substance
- PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
- Active strength
- 4; .5 g/20mL; g/20mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0409-3390 | D | Discontinued by firm | 2026-09-09 | ||
| excluded package | package | 0409-3390 | 0409-3390-51 | D | Discontinued by firm | 2026-09-09 | |
| excluded package | package | 0409-3390 | 0409-3390-04 | D | Discontinued by firm | 2026-09-09 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0409-3390-51 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0409-3390-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0409-3390-51 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0409-3390-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0409-3390-51 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0409-3390-51 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0409-3390-51 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0409-3390-51 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0409-3390-51 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0409-3390-51 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0409-3390-51 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0409-3390-51 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0409-3390-51 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0409-3390-51 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065362-001 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | |
| A065362-002 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | |
| A065362-003 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065362-001 | AP |
| A065362-002 | AP |
| A065362-003 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065362-002 | PIPERACILLIN AND TAZOBACTAM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065362-003 | PIPERACILLIN AND TAZOBACTAM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065362-001 | PIPERACILLIN AND TAZOBACTAM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-10-21 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A065362-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065362-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065362-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065362-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065362-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065362-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065362-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065362-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065362-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065362-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065362-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065362-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065362-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065362-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065362-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065362-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065362-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065362-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065362-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065362-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065362-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065362-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065362-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065362-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065362-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065362-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065362-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065362-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065362-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065362-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065362-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065362-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065362-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065362-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065362-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065362-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065362-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065362-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065362-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065362-001 | AP | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Piperacillin and Tazobactam
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PIPERACILLIN SODIUM | 4 g/20mL |
| TAZOBACTAM SODIUM | .5 g/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| M98T69Q7HP | Internal UNII lookup |
| UXA545ABTT | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5fa255cf-091e-4504-8ebf-eef4259776e8 | Product name | 1 | 20260112 |
| a6bfe911-d09e-4049-bcde-a3213184a72c | Product name | 8 | 20240501 |
| 61877847-a958-4874-a7cf-2bbeff51a37b | Product name | 2 | 20180717 |
| e0d9b1cf-1fe5-42a8-b30f-70b3a7bd8d22 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0409-3390-04 | Piperacillin and Tazobactam | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | 28 | |
| 0409-3390-10 | Piperacillin and Tazobactam | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | 28 | |
| 0409-3390-11 | Piperacillin and Tazobactam | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 | 28 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-3390-04 | EA - Each | 0409-3390 | 9a15f3a0-6eae-4f60-a143-1b30743ea741 | 1 | 2012-07-24 |
| 0409-3390-10 | EA - Each | 0409-3390 | e30c043b-652b-4518-95ed-71442a9fb663 | 1 | 2025-07-08 |
| 0409-3390-11 | EA - Each | 0409-3390 | 05aad8c1-3822-4721-8e1c-c2e0a7900e42 | 1 | 2019-06-19 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PIPERACILLIN SODIUM | ACTIVE INGREDIENT | M98T69Q7HP | PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC] | 13 | |
| TAZOBACTAM SODIUM | ACTIVE INGREDIENT | UXA545ABTT | PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC] | 13 | |
| PIPERACILLIN ANHYDROUS | ACTIVE MOIETY | 9I628532GX | PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC] | 13 | |
| TAZOBACTAM | ACTIVE MOIETY | SE10G96M8W | PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC] | 13 |
DailyMed Dashboard NDC Coverage#
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 AND TAZOBACTAM | Sandoz Inc | 9b682c66-61c6-4ade-baf4-9d68911a16b8 | 2024-10-30 | Warnings, Adverse reactions | 065362 ANDA065362 |
| Piperacillin and Tazobactam | PIPERACILLIN AND TAZOBACTAM | Hospira, Inc | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 2024-10-25 | Warnings, Adverse reactions | 065362 ANDA065362 0409-3390 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1659131 | piperacillin / tazobactam 2.25 GM Injection | PSN | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659137 | piperacillin / tazobactam 3.375 GM Injection | PSN | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659149 | piperacillin / tazobactam 4.5 GM Injection | PSN | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659131 | piperacillin 2000 MG / tazobactam 250 MG Injection | SCD | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659137 | piperacillin 3000 MG / tazobactam 375 MG Injection | SCD | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659149 | piperacillin 4000 MG / tazobactam 500 MG Injection | SCD | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659131 | piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG Injection | SY | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659137 | piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG Injection | SY | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659149 | piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG Injection | SY | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659131 | piperacillin / tazobactam 2.25 GM Injection | SY | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659137 | piperacillin / tazobactam 3.375 GM Injection | SY | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
| 1659149 | piperacillin / tazobactam 4.5 GM Injection | SY | 4d3f4b69-b0b9-494f-9cda-4537fa420d47 | 28 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0409-3390-04 | 00409339004 | 10 VIAL, SINGLE-USE in 1 CARTON (0409-3390-04) > 20 mL in 1 VIAL, SINGLE-USE (0409-3390-11) | 2010-10-21 | 0000-00-00 | No | No | Current | |
| 0409-3390-10 | 00409339010 | 10 VIAL, SINGLE-USE in 1 CARTON (0409-3390-10) / 20 mL in 1 VIAL, SINGLE-USE (0409-3390-11) | 2025-06-09 | No | No | Current | ||
| 0409-3390-11 | 00409339011 | 20 mL in 1 VIAL, SINGLE-USE | 20 ml | Historical |