Application 065458

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	No	No
002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	INJECTABLE;INJECTION	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	No	No
003	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	INJECTABLE;INJECTION	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	No	No

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…`

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 ndc (product): 72485-403
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 ndc (product): 72485-404

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-521	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-521	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-521	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-521	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-521	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-522	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-522	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-522	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-522	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-522	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-523	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-523	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-523	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-523	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
67457-523	piperacillin and tazobactam	piperacillin and tazobactam	Mylan Institutional LLC	ANDA	Current
72485-403	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Armas Pharmaceuticals Inc.	ANDA	Current
72485-404	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Armas Pharmaceuticals Inc.	ANDA	Current
82449-500	piperacillin and tazobactam	piperacillin and tazobactam	Steriscience Specialties Private Limited	ANDA	Current
82449-501	piperacillin and tazobactam	piperacillin and tazobactam	Steriscience Specialties Private Limited	ANDA	Current
82449-502	piperacillin and tazobactam	piperacillin and tazobactam	Steriscience Specialties Private Limited	ANDA	Current