Application 074069

Type: ANDA
Sponsor: AMNEAL PHARMS LLC

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	75MG	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074069-001	AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16
A074069-002	AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02
A074069-003	AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074069-001	AB
A074069-002	AB
A074069-003	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 3 · 107 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	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074069-002	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2021-11-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074069-003	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2021-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074069-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1996-02-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 107 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	A074069-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074069-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074069-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074069-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074069-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074069-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074069-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074069-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074069-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074069-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074069-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074069-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074069-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074069-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074069-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074069-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074069-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074069-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074069-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074069-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074069-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074069-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074069-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074069-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074069-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074069-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074069-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074069-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074069-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074069-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074069-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074069-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074069-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074069-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074069-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074069-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074069-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074069-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074069-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074069-001	AB	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AZATHIOPRINE	AZATHIOPRINE	PD-Rx Pharmaceuticals, Inc.	d288e484-32fc-4b46-b504-d75a0fac8663	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074069 application number: ANDA074069 ndc (product): 72789-129
AZATHIOPRINE	AZATHIOPRINE	AvKARE	f93d9408-7b3f-b423-e053-6294a90a31ec	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074069 application number: ANDA074069
AZATHIOPRINE	AZATHIOPRINE	AvKARE	d4c7d621-9642-4027-e053-2995a90a9220	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074069 application number: ANDA074069 ndc (product): 42291-071
AZATHIOPRINE	AZATHIOPRINE	Amneal Pharmaceuticals NY LLC	59f3219f-898f-4d05-a430-c2b3f5255af1	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074069 application number: ANDA074069 ndc (product): 60219-2037 ndc (product): 60219-1076 ndc (product): 60219-2036
AZATHIOPRINE	AZATHIOPRINE	Amneal Pharmaceuticals NY LLC	c49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c	2021-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074069 application number: ANDA074069 ndc (product): 69238-1076
AZATHIOPRINE	AZATHIOPRINE	Aphena Pharma Solutions - Tennessee, LLC	2f994aed-f8e7-4967-a167-b22b783b4192	2018-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074069 application number: ANDA074069 ndc (product): 71610-124

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7568	Azathioprine	Azathioprine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42291-071	AZATHIOPRINE	Azathioprine	AvKARE	ANDA	Current
42291-071	AZATHIOPRINE	Azathioprine	AvKARE	ANDA	Current
60219-1076	AZATHIOPRINE	Azathioprine	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1076	AZATHIOPRINE	Azathioprine	Amneal Pharmaceuticals LLC	ANDA	Current
60219-1076	AZATHIOPRINE	Azathioprine	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1076	AZATHIOPRINE	Azathioprine	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1076	AZATHIOPRINE	Azathioprine	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-2036	AZATHIOPRINE	Azathioprine	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-2036	AZATHIOPRINE	Azathioprine	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-2037	AZATHIOPRINE	Azathioprine	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-2037	AZATHIOPRINE	Azathioprine	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1076	AZATHIOPRINE	Azathioprine	Amneal Pharmaceuticals of New York, LLC	ANDA	Current
71610-124	AZATHIOPRINE	Azathioprine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72789-129	AZATHIOPRINE	Azathioprine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-129	AZATHIOPRINE	Azathioprine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-129	AZATHIOPRINE	Azathioprine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-129	AZATHIOPRINE	Azathioprine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current