Azathioprine

Product NDC: 33261-758
11-digit product format: 332610758
Labeler code: 33261
Product ID: 33261-758_7e7541d1-017e-4bcc-8ae6-3735c2b5d307
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azathioprine
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA077621
Marketing category: ANDA
Marketing start: 2007-07-11
Marketing end: 0000-00-00
Substance: AZATHIOPRINE
Active strength: 50 mg/1
Pharmacologic classes: Nucleoside Analog [EXT],Purine Antimetabolite [EPC],Purines [CS],Nucleic Acid Synthesis Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
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	33261-758		I	Inactivated by FDA		2026-08-03
excluded package	package	33261-758	33261-758-75	I	Inactivated by FDA		2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-758-75	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-758-75	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-758-75	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-758-75	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-758-75	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-758-75	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-758-75	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-758-75	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-758-75	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-758-75	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-758-75	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-758-75	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-758-75	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-758-75	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-758-75	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	33261-758-75	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	33261-758-75	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	33261-758-75	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	33261-758-75	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	33261-758-75	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	33261-758-75	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	33261-758-75	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4f4d1a46-20f1-4d12-8172-10a68a29bd37	Product name	1	20200714
6675d21e-6399-b5b7-7c97-62806f9c86aa	Product name	2	20200714
e3ccdd15-9c9c-362f-f2a0-79d5e384527f	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-758-75	2020-01-31	C162847	48780-1	9d75b9d0-2ea5-f424-e053-dadaa90a57ce	Azathioprine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-758-75	Azathioprine	75 in 1 BOTTLE	TABLET	75		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZATHIOPRINE	ACTIVE INGREDIENT	MRK240IY2L	AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
AZATHIOPRINE	ACTIVE MOIETY	MRK240IY2L	AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-758	AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20120912_3ebf1c18-4ecd-486d-be4e-f1e765a9ad6d.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 · 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
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
Azathioprine	AZATHIOPRINE	Zydus Lifesciences Limited	d65bc662-2ae8-4ddb-acc8-f616e72e6140	2024-11-25		Exact identifier application applno (ANDA): 077621 application number: ANDA077621
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MRK240IY2L	AZATHIOPRINE	446-86-6	AZATHIOPRINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197388	azaTHIOprine 50 MG Oral Tablet	PSN	3ebf1c18-4ecd-486d-be4e-f1e765a9ad6d	1
197388	azathioprine 50 MG Oral Tablet	SCD	3ebf1c18-4ecd-486d-be4e-f1e765a9ad6d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-758-75	33261075875	75 in 1 BOTTLE	Historical