Application 077621

Type: ANDA
Sponsor: ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZATHIOPRINE	AZATHIOPRINE	TABLET;ORAL	50MG	No	No
002	AZATHIOPRINE	AZATHIOPRINE	TABLET;ORAL	25MG	No	No
003	AZATHIOPRINE	AZATHIOPRINE	TABLET;ORAL	75MG	No	No
004	AZATHIOPRINE	AZATHIOPRINE	TABLET;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077621-001	AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15
A077621-002	AZATHIOPRINE	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05
A077621-003	AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05
A077621-004	AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A077621-001	AB
A077621-002	AB
A077621-003	AB
A077621-004	AB

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 5 · 164 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	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A077621-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077621-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077621-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077621-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077621-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077621-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077621-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077621-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077621-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077621-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077621-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077621-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077621-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077621-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077621-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077621-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077621-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077621-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077621-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077621-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077621-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077621-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077621-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077621-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077621-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077621-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077621-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077621-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077621-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077621-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077621-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077621-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077621-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077621-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077621-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077621-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077621-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077621-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077621-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077621-004	AB	1	`d06236e962d9…`

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
Azathioprine	AZATHIOPRINE	American Health Packaging	040d010a-b1b2-4db7-905d-8aa7f1bab0cd	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077621 application number: ANDA077621 ndc (product): 68084-229
Azathioprine	AZATHIOPRINE	NuCare Pharmaceuticals, Inc.	2b9f91b9-7959-65e7-e063-6294a90a3680	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077621 application number: ANDA077621
Azathioprine	AZATHIOPRINE	Zydus Lifesciences Limited	89b272f0-ef5c-49e4-820f-fcd7ea8ef066	2024-11-25		Exact identifier application applno (ANDA): 077621 application number: ANDA077621 ndc (product): 70771-1140 ndc (product): 70771-1139 ndc (product): 70771-1141
Azathioprine	AZATHIOPRINE	Zydus Lifesciences Limited	d65bc662-2ae8-4ddb-acc8-f616e72e6140	2024-11-25		Exact identifier application applno (ANDA): 077621 application number: ANDA077621 ndc (product): 65841-602
Azathioprine	AZATHIOPRINE	Zydus Pharmaceuticals USA Inc.	b1b0fa3e-11c3-46d0-9537-6b372c2a1b56	2024-08-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077621 application number: ANDA077621 ndc (product): 68382-118 ndc (product): 68382-003 ndc (product): 68382-120 ndc (product): 68382-119

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-484	Azathioprine	Azathioprine	Rebel Distributors Corp..	ANDA	Current
33261-758	Azathioprine	Azathioprine	Aidarex Pharmaceuticals LLC	ANDA	Current
65841-602	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
65841-602	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
65841-602	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
65841-602	Azathioprine	Azathioprine	Zydus Lifesciences Limited	ANDA	Current
68084-229	Azathioprine	Azathioprine	American Health Packaging	ANDA	Current
68084-229	Azathioprine	Azathioprine	American Health Packaging	ANDA	Current
68084-229	Azathioprine	Azathioprine	American Health Packaging	ANDA	Current
68382-003	Azathioprine	Azathioprine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-003	Azathioprine	Azathioprine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-003	Azathioprine	Azathioprine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-118	Azathioprine	Azathioprine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-118	Azathioprine	Azathioprine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-118	Azathioprine	Azathioprine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-119	Azathioprine	Azathioprine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-119	Azathioprine	Azathioprine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-119	Azathioprine	Azathioprine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-120	Azathioprine	Azathioprine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-120	Azathioprine	Azathioprine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-120	Azathioprine	Azathioprine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1139	Azathioprine	Azathioprine	Zydus Lifesciences Limited	ANDA	Current
70771-1139	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
70771-1139	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
70771-1139	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
70771-1140	Azathioprine	Azathioprine	Zydus Lifesciences Limited	ANDA	Current
70771-1140	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
70771-1140	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
70771-1140	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
70771-1141	Azathioprine	Azathioprine	Zydus Lifesciences Limited	ANDA	Current
70771-1141	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
70771-1141	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current
70771-1141	Azathioprine	Azathioprine	Cadila Healthcare Limited	ANDA	Current