Azathioprine

Product NDC: 67877-494
Requested package NDC: 67877-494-05
11-digit product format: 678770494
Labeler code: 67877
Product ID: 67877-494_7fdec2f6-c3b5-483f-8bfc-0afb292781da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azathioprine
Dosage form: TABLET
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA208687
Marketing category: ANDA
Marketing start: 2020-03-29
Substance: AZATHIOPRINE
Active strength: 75 mg/1
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208687-001	AZATHIOPRINE	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27
A208687-002	AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27
A208687-003	AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27
A208687-004	AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208687-001	AB
A208687-002	AB
A208687-003	AB
A208687-004	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 4 · 156 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
2026-09-14 22:38:34	2026-08	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208687-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208687-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208687-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208687-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208687-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208687-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208687-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208687-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208687-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208687-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Azathioprine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZATHIOPRINE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MRK240IY2L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197388	Internal RxNorm lookup
199310	Internal RxNorm lookup
359228	Internal RxNorm lookup
359229	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bc6dc4bd-2121-4613-9d90-4a504010c98a	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67877-494-01	Azathioprine	100 in 1 BOTTLE	TABLET	100	9
67877-494-05	Azathioprine	500 in 1 BOTTLE	TABLET	500	9
67877-494-10	Azathioprine	1000 in 1 BOTTLE	TABLET	1000	9
67877-494-33	Azathioprine	10 in 1 BLISTER PACK	TABLET	10	9
67877-494-38	Azathioprine	10 in 1 CARTON	TABLET	10	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-494	AZATHIOPRINE TABLET [ASCEND LABORATORIES, LLC]	9	Current NDC, Legacy NDC, 5 package rows	20250425_bc6dc4bd-2121-4613-9d90-4a504010c98a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azathioprine	AZATHIOPRINE	NuCare Pharmaceuticals,Inc.	5116b22b-1460-5535-e063-6394a90acbe5	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208687 application number: ANDA208687
Azathioprine	AZATHIOPRINE	REMEDYREPACK INC.	f251f372-c881-483e-8035-c6a8a6bfb4e8	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208687 application number: ANDA208687
Azathioprine	AZATHIOPRINE	Ascend Laboratories, LLC	bc6dc4bd-2121-4613-9d90-4a504010c98a	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208687 application number: ANDA208687 ndc (package): 67877-494-05 ndc (product): 67877-494 ndc11 (package): 67877049405

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
359228	azaTHIOprine 100 MG Oral Tablet	PSN	bc6dc4bd-2121-4613-9d90-4a504010c98a	9
199310	azaTHIOprine 25 MG Oral Tablet	PSN	bc6dc4bd-2121-4613-9d90-4a504010c98a	9
197388	azaTHIOprine 50 MG Oral Tablet	PSN	bc6dc4bd-2121-4613-9d90-4a504010c98a	9
359229	azaTHIOprine 75 MG Oral Tablet	PSN	bc6dc4bd-2121-4613-9d90-4a504010c98a	9
359228	azathioprine 100 MG Oral Tablet	SCD	bc6dc4bd-2121-4613-9d90-4a504010c98a	9
199310	azathioprine 25 MG Oral Tablet	SCD	bc6dc4bd-2121-4613-9d90-4a504010c98a	9
197388	azathioprine 50 MG Oral Tablet	SCD	bc6dc4bd-2121-4613-9d90-4a504010c98a	9
359229	azathioprine 75 MG Oral Tablet	SCD	bc6dc4bd-2121-4613-9d90-4a504010c98a	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-494-05	67877049405	500 TABLET in 1 BOTTLE (67877-494-05)	500 tablet	2020-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azathioprine Tablets, USP Scored Tablets PRODUCT INFORMATION Rx only	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2025-04-23	Human Prescription Drug Label	9