Piperacillin and Tazobactam

Product NDC: 83634-112
11-digit product format: 836340112
Labeler code: 83634
Product ID: 83634-112_2f01070f-edc6-404f-bad8-1b0071c32b5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: piperacillin and tazobactam
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Avenacy, LLC
Application: ANDA090498
Marketing category: ANDA
Marketing start: 2025-09-01
Substance: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength: 36; 4.5 g/180mL; g/180mL
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 1.

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
A090498-001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2011-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090498-001	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.

Product history page 1 of 2 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090498-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090498-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090498-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090498-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090498-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090498-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090498-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090498-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090498-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090498-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090498-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090498-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090498-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090498-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090498-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090498-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090498-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090498-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090498-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090498-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090498-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090498-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090498-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090498-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090498-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090498-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090498-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090498-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090498-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090498-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090498-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090498-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090498-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090498-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090498-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090498-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090498-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090498-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090498-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090498-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090498-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIPERACILLIN SODIUM	36 g/180mL
TAZOBACTAM SODIUM	4.5 g/180mL

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
668a2730-e95a-4639-a506-ae95a6502ca1	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
83634-112-99	Piperacillin and Tazobactam	180 mL in 1 BOTTLE	INJECTION, POWDER, FOR SOLUTION	180		1
83634-112-99	Piperacillin and Tazobactam	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83634-112-99	EA - Each	83634-112	3081ebf3-eb4a-44ca-a9e2-975a97e3aec4	1	2026-02-05

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	WG Critical Care, LLC	17a400ae-cbaa-4d07-95f4-c6917dfc0585	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090498 application number: ANDA090498
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Avenacy, LLC	668a2730-e95a-4639-a506-ae95a6502ca1	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090498 application number: ANDA090498 ndc (product): 83634-112
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	Exact identifier application applno (ANDA): 090498 application number: ANDA090498
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	Exact identifier application applno (ANDA): 090498 application number: ANDA090498
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	Exact identifier application applno (ANDA): 090498 application number: ANDA090498

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	668a2730-e95a-4639-a506-ae95a6502ca1	1
312447	piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable Solution	SCD	668a2730-e95a-4639-a506-ae95a6502ca1	1
312447	piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable Solution	SY	668a2730-e95a-4639-a506-ae95a6502ca1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83634-112-99	83634011299	1 BOTTLE in 1 CARTON (83634-112-99) / 180 mL in 1 BOTTLE	1 bottle	2025-09-01	No	No	Current