Piperacillin, Tazobactam

Product NDC: 25021-181
11-digit product format: 250210181
Labeler code: 25021
Product ID: 25021-181_a6724256-14c5-4408-83a5-a964f146f0d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Piperacillin Sodium, Tazobactam Sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA208675
Marketing category: ANDA
Marketing start: 2021-02-28
Substance: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength: 36; 4.5 g/152mL; g/152mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208675-001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208675-001	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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208675-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-02-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208675-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208675-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208675-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208675-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208675-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208675-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208675-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208675-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208675-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208675-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208675-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208675-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208675-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208675-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208675-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208675-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208675-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208675-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208675-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208675-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208675-001	AP	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208675-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208675-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208675-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208675-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208675-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208675-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208675-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208675-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208675-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208675-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208675-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208675-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208675-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208675-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Piperacillin, Tazobactam
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIPERACILLIN SODIUM	36 g/152mL
TAZOBACTAM SODIUM	4.5 g/152mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M98T69Q7HP	Internal UNII lookup
UXA545ABTT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312447	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
83f4adcd-893c-4e9e-8f2b-e06299dcf34d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
25021-181-99	Piperacillin, Tazobactam	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		14
25021-181-99	Piperacillin, Tazobactam	152 mL in 1 BOTTLE	INJECTION, POWDER, LYOPHILIZED,	152		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-181-99	EA - Each	25021-181	ac169699-2bc9-44e4-8ac3-3e023f4cbbac	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-181	PIPERACILLIN, TAZOBACTAM (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]	14	Current NDC, Legacy NDC, 2 package rows	20241120_83f4adcd-893c-4e9e-8f2b-e06299dcf34d.zip

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Piperacillin, Tazobactam	PIPERACILLIN SODIUM, TAZOBACTAM SODIUM	Sagent Pharmaceuticals	83f4adcd-893c-4e9e-8f2b-e06299dcf34d	2024-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208675 application number: ANDA208675 ndc (product): 25021-181

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312447	piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable Solution	PSN	83f4adcd-893c-4e9e-8f2b-e06299dcf34d	14
312447	piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable Solution	SCD	83f4adcd-893c-4e9e-8f2b-e06299dcf34d	14
312447	piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable Solution	SY	83f4adcd-893c-4e9e-8f2b-e06299dcf34d	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-181-99	25021018199	1 BOTTLE in 1 CARTON (25021-181-99) / 152 mL in 1 BOTTLE	1 bottle	2021-02-28	0000-00-00	No	No	Current