Piperacillin and Tazobactam

Product NDC: 72572-577
Requested package NDC: 72572-577-10
11-digit product format: 725720577
Labeler code: 72572
Product ID: 72572-577_2919e37d-528c-413a-aad3-eb5d116718ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Piperacillin Sodium and Tazobactam Sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Civica, Inc.
Application: ANDA212287
Marketing category: ANDA
Marketing start: 2022-01-20
Marketing end: 0000-00-00
Substance: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength: 4 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: 2023-12-31
Current FDA listing: Historical FDA.report record

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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72572-577	72572-577-10	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.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A212287-001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29
A212287-002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29
A212287-003	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212287-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212287-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212287-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	2019-07-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212287-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212287-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212287-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212287-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212287-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212287-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212287-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212287-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212287-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212287-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212287-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212287-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212287-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212287-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212287-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212287-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212287-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212287-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212287-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212287-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212287-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212287-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212287-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212287-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212287-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A212287-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A212287-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212287-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A212287-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A212287-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212287-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A212287-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A212287-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212287-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A212287-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A212287-003	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212287-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212287-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212287-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212287-001	AP	1	`1c564ffb4f44…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72572-577-10	2024-01-30	C162847	48780-1	1030e365-1837-111a-e063-dadaa90a10e2	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, for intravenous use Initial U.S. Approval: 1993

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72572-577-01	EA - Each	72572-577	e9f3fe94-da80-4017-a398-4e091d78aa86	1	2022-03-09
72572-577-10	EA - Each	72572-577	69518041-7a4a-4599-9b82-376cbfe11e58	1	2022-03-09

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M98T69Q7HP	PIPERACILLIN SODIUM	59703-84-3	PIPERACILLIN SODIUM
UXA545ABTT	TAZOBACTAM SODIUM	89785-84-2	TAZOBACTAM SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72572-577-10	72572057710	10 VIAL, SINGLE-DOSE in 1 CARTON (72572-577-10) > 20 mL in 1 VIAL, SINGLE-DOSE (72572-577-01)	2022-01-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Piperacillin and Tazobactam	Civica, Inc. \| Astral SteriTech Pvt. Ltd.	2022-09-09	HUMAN PRESCRIPTION DRUG LABEL	2