PIPERACILLIN AND TAZOBACTAM

Product NDC: 71357-023
11-digit product format: 713570023
Labeler code: 71357
Product ID: 71357-023_5b9a9281-51b9-b72a-e063-6294a90aac89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PIPERACILLIN AND TAZOBACTAM
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: MILLA PHARMACEUTICALS INC.
Application: ANDA207848
Marketing category: ANDA
Marketing start: 2019-08-01
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: 2027-12-31
Current FDA listing: Yes

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
A207848-001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2018-05-11
A207848-002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2017-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207848-001	AP
A207848-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207848-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207848-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-13	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A207848-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207848-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207848-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207848-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207848-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207848-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207848-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207848-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207848-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207848-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207848-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207848-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207848-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207848-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207848-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207848-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207848-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207848-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207848-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207848-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207848-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207848-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207848-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207848-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207848-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207848-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207848-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207848-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207848-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207848-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207848-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207848-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207848-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207848-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207848-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207848-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207848-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207848-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207848-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207848-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: PIPERACILLIN AND TAZOBACTAM
Listing expiration: 2027-12-31

Active Ingredients#

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

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 and Tazobactam	PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM	Provepharm Inc.	68d5384d-1691-4afc-8a1a-488f8e2ef2c5	2025-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207848 application number: ANDA207848

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	Sample	Exclude flag	Status
71357-023-01	71357002301	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71357-023-01) / 60 mL in 1 VIAL, PHARMACY BULK PACKAGE	2026-09-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PIPERACILLIN AND TAZOBACTAM	MILLA PHARMACEUTICALS INC. \| Mitim S.r.I.	2026-09-16	HUMAN PRESCRIPTION DRUG LABEL	2