Piperacillin and Tazobactam

Product NDC: 22607-012
Requested package NDC: 22607-012-02
11-digit product format: 226070012
Labeler code: 22607
Product ID: 22607-012_59c0c9d5-2a0a-4591-984a-039b3fdc6194
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: piperacillin sodium and tazobactam sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Mitim S.r.l.
Application: ANDA206996
Marketing category: ANDA
Marketing start: 2017-03-22
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 Inhibitors [MoA],beta Lactamase Inhibitor [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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
unfinished package	package	22607-012	22607-012-02	UNFINISHED	Active or certified unfinished drug listing		2026-08-17

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 · 4 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`

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	TE codes	RLD / RS	Approval date
A206996-001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22
A206996-002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22
A206996-003	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A206996-001	AP
A206996-002	AP
A206996-003	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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
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	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206996-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206996-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206996-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-03-22	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206996-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206996-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206996-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206996-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206996-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206996-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206996-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206996-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206996-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206996-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206996-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206996-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206996-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206996-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206996-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206996-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206996-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206996-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206996-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206996-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206996-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206996-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206996-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206996-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206996-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206996-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206996-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206996-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206996-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206996-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206996-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206996-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206996-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206996-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206996-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206996-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206996-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206996-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206996-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206996-001	AP	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIPERACILLIN SODIUM	4 g/20mL
TAZOBACTAM SODIUM	.5 g/20mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
22607-012-01	2020-01-31	C162847	48780-1	9d75b9d0-282a-f424-e053-dadaa90a57ce	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

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	Units	Marketing start	Status
22607-012-02	22607001202	10 CARTON in 1 BOX (22607-012-02) / 10 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE	10 carton	22-MAR-17	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Piperacillin and Tazobactam	Mitim S.r.l. \| Wockhardt Limited	2017-03-29	HUMAN PRESCRIPTION DRUG LABEL	1