Piperacillin and Tazobactam

Product NDC: 43858-153
11-digit product format: 438580153
Labeler code: 43858
Product ID: 43858-153_8a7379bb-0c6c-4814-8d1b-d03d4094726e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Piperacillin and Tazobactam
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS; PARENTERAL
Labeler: Sandoz GmbH
Application: ANDA203557
Marketing category: ANDA
Marketing start: 2016-12-14
Marketing end: 0000-00-00
Substance: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength: 12 g/100mL; g/100mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203557-001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29
A203557-002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203557-001	AP
A203557-002	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 · 78 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
2026-09-14 22:38:34	2026-08	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-10-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203557-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203557-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203557-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203557-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203557-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203557-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203557-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203557-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203557-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203557-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203557-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203557-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203557-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203557-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203557-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203557-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203557-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203557-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203557-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203557-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203557-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203557-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203557-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203557-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203557-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203557-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203557-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203557-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203557-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203557-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203557-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203557-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203557-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203557-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203557-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203557-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203557-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203557-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203557-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203557-001	AP	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Sandoz Inc	b1cb1314-d3e0-4b44-a1df-de14c32e8cc6	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203557 application number: ANDA203557
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Hospira, Inc	5e8bbfcd-3618-43ed-a158-9d524426fdc5	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203557 application number: ANDA203557

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
43858-153-46	43858015346	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (43858-153-46) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE	2016-12-14	0000-00-00	No	No	Current