Azathioprine

Product NDC: 43353-745
11-digit product format: 433530745
Labeler code: 43353
Product ID: 43353-745_2a5598d0-3932-4397-97b3-5d63dc7af1f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azathioprine
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075568
Marketing category: ANDA
Marketing start: 2009-12-28
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: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-745		I	Inactivated by FDA	2026-10-15
excluded package	package	43353-745	43353-745-09	I	Inactivated by FDA	2026-10-15
excluded package	package	43353-745	43353-745-60	I	Inactivated by FDA	2026-10-15

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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-745-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-745-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-745-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-745-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-745-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-745-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-745-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-745-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-745-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-745-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-745-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-745-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-745-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-745-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-745-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-745-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-745-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-745-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-745-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-745-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-745-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-745-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-745-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-745-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-745-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-745-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-745-09	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-745-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-745-09	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-745-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-745-09	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-745-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-745-09	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-745-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-745-09	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-745-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-745-09	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-745-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-745-09	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-745-60	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075568-001	AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET / ORAL	AB		1999-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075568-001	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 2 · 44 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
2026-10-15 13:18:30	2026-09	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075568-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-12-13	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A075568-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075568-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075568-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075568-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
43353-745-09	2020-01-31	C162847	48780-1	9d75b9d0-f2e9-f424-e053-dadaa90a57ce	8f8e2691-4dd9-4f92-b1dd-9fc8b272768d
43353-745-60	2020-01-31	C162847	48780-1	9d75b9d0-f2e9-f424-e053-dadaa90a57ce	8f8e2691-4dd9-4f92-b1dd-9fc8b272768d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-745-09	Azathioprine	9000 in 1 BOTTLE, PLASTIC	TABLET	9000		1
43353-745-60	Azathioprine	90 in 1 BOTTLE, PLASTIC	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-745-09	EA - Each	43353-745	273cf3cf-ba22-472b-94f4-b835860c538e	1	2017-12-14
43353-745-60	EA - Each	43353-745	d8cfb027-045a-4528-b31b-e2ea07a19daa	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-745	AZATHIOPRINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 2 package rows	20171201_8f8e2691-4dd9-4f92-b1dd-9fc8b272768d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AZATHIOPRINE	AZATHIOPRINE	Rising Pharma Holdings, Inc.	2ffa2fce-895d-469e-8667-b078560aec5f	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075568 application number: ANDA075568

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	8f8e2691-4dd9-4f92-b1dd-9fc8b272768d	1
197388	azathioprine 50 MG Oral Tablet	SCD	8f8e2691-4dd9-4f92-b1dd-9fc8b272768d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-745-09	43353074509	9000 in 1 BOTTLE, PLASTIC	Historical
43353-745-60	43353074560	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azathioprine - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2017-11-30	HUMAN PRESCRIPTION DRUG LABEL	1