piperacillin and tazobactam

Product NDC: 82449-501
11-digit product format: 824490501
Labeler code: 82449
Product ID: 82449-501_e83e5a9f-601d-347f-e053-2a95a90ae338
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: piperacillin and tazobactam
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Steriscience Specialties Private Limited
Application: ANDA065458
Marketing category: ANDA
Marketing start: 2015-08-14
Marketing end: 0000-00-00
Substance: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength: 3 g/15mL; g/15mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	82449-501		D	Discontinued by firm		2026-08-10
excluded package	package	82449-501	82449-501-02	D	Discontinued by firm		2026-08-10

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	82449-501		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82449-501	82449-501-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A065458-001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15
A065458-002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15
A065458-003	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065458-001	AP
A065458-002	AP
A065458-003	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 · 123 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	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065458-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065458-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065458-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 110 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	A065458-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065458-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065458-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065458-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065458-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065458-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065458-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065458-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065458-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065458-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065458-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065458-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065458-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065458-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065458-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065458-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065458-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065458-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065458-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065458-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065458-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065458-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065458-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065458-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065458-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065458-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065458-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065458-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065458-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065458-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065458-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065458-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065458-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065458-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065458-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065458-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065458-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065458-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065458-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065458-001	AP	1	`8072bd15b7f6…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82449-501	PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED]	13	Legacy NDC	20241205_0b90641f-bdcf-474a-a457-01884c5f8023.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
piperacillin and tazobactam	PIPERACILLIN AND TAZOBACTAM	Civica, Inc.	7aebc0e6-89db-4ef0-b5ab-d6b3199bcfc4	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065458 application number: ANDA065458
piperacillin and tazobactam	PIPERACILLIN AND TAZOBACTAM	ONESOURCE SPECIALTY PHARMA LIMITED	28258745-12e4-4f0f-b318-4a1a1bebc928	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065458 application number: ANDA065458
piperacillin and tazobactam	PIPERACILLIN AND TAZOBACTAM	Armas Pharmaceuticals Inc.	24d9b4f1-109c-4db4-8a99-03afff045b47	2024-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065458 application number: ANDA065458
piperacillin and tazobactam	PIPERACILLIN AND TAZOBACTAM	Armas Pharmaceuticals Inc.	bbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a	2024-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065458 application number: ANDA065458

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
82449-501-02	82449050102	10 VIAL, SINGLE-USE in 1 CARTON (82449-501-02) > 15 mL in 1 VIAL, SINGLE-USE (82449-501-01)	2015-08-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
piperacillin and tazobactam	Steriscience Specialties Private Limited \| Steriscience Specialities Pte. Limited	2024-09-27	HUMAN PRESCRIPTION DRUG LABEL	13