AZATHIOPRINE

Product NDC: 42291-063
Requested package NDC: 42291-063-01
11-digit product format: 422910063
Labeler code: 42291
Product ID: 42291-063_485b4c20-1aeb-8ffd-e063-6294a90a104f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azathioprine
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA074069
Marketing category: ANDA
Marketing start: 2023-04-13
Substance: AZATHIOPRINE
Active strength: 100 mg/1
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: AZATHIOPRINE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZATHIOPRINE	100 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359228	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
f93d9408-7b3f-b423-e053-6294a90a31ec	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	Strength	SPL version
42291-063-01	AZATHIOPRINE	100 in 1 BOTTLE	TABLET	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-063-01	EA - Each	42291-063	147cdb97-129b-472d-b6be-f89e8f352849	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-063	AZATHIOPRINE TABLET [AVKARE]	1	Current NDC, 1 package rows	20230415_f93d9408-7b3f-b423-e053-6294a90a31ec.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 · 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
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 ndc (package): 42291-063-01 ndc (product): 42291-063 ndc11 (package): 42291006301
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
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
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
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

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	f93d9408-7b3f-b423-e053-6294a90a31ec	2
359228	azathioprine 100 MG Oral Tablet	SCD	f93d9408-7b3f-b423-e053-6294a90a31ec	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-063-01	42291006301	100 TABLET in 1 BOTTLE (42291-063-01)	100 tablet	2023-04-13	No	No	Current