Azathioprine

Product NDC: 68382-118
11-digit product format: 683820118
Labeler code: 68382
Product ID: 68382-118_64e1751f-fdf5-45e7-ac57-6499c0b5aa91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azathioprine
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA077621
Marketing category: ANDA
Marketing start: 2017-12-02
Substance: AZATHIOPRINE
Active strength: 25 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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZATHIOPRINE	25 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
b1b0fa3e-11c3-46d0-9537-6b372c2a1b56	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
68382-118-01	Azathioprine	100 in 1 BOTTLE	TABLET	100	11
68382-118-05	Azathioprine	500 in 1 BOTTLE	TABLET	500	11
68382-118-01	Azathioprine	100 in 1 BOTTLE	TABLET	100	6
68382-118-05	Azathioprine	500 in 1 BOTTLE	TABLET	500	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZATHIOPRINE	ACTIVE INGREDIENT	MRK240IY2L	AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	5
AZATHIOPRINE	ACTIVE MOIETY	MRK240IY2L	AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-118	AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS USA INC.]	11	Current NDC, Legacy NDC, 2 package rows	20240811_b1b0fa3e-11c3-46d0-9537-6b372c2a1b56.zip
68382-118	AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS USA INC.]	6	Current NDC, Legacy NDC, 2 package rows	20230917_1cd03d78-d567-4449-be98-0e8652ceff6a.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 ndc (product): 68382-118

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	b1b0fa3e-11c3-46d0-9537-6b372c2a1b56	11
199310	azaTHIOprine 25 MG Oral Tablet	PSN	b1b0fa3e-11c3-46d0-9537-6b372c2a1b56	11
197388	azaTHIOprine 50 MG Oral Tablet	PSN	b1b0fa3e-11c3-46d0-9537-6b372c2a1b56	11
359229	azaTHIOprine 75 MG Oral Tablet	PSN	b1b0fa3e-11c3-46d0-9537-6b372c2a1b56	11
359228	azathioprine 100 MG Oral Tablet	SCD	b1b0fa3e-11c3-46d0-9537-6b372c2a1b56	11
199310	azathioprine 25 MG Oral Tablet	SCD	b1b0fa3e-11c3-46d0-9537-6b372c2a1b56	11
197388	azathioprine 50 MG Oral Tablet	SCD	b1b0fa3e-11c3-46d0-9537-6b372c2a1b56	11
359229	azathioprine 75 MG Oral Tablet	SCD	b1b0fa3e-11c3-46d0-9537-6b372c2a1b56	11
359228	azaTHIOprine 100 MG Oral Tablet	PSN	1cd03d78-d567-4449-be98-0e8652ceff6a	6
199310	azaTHIOprine 25 MG Oral Tablet	PSN	1cd03d78-d567-4449-be98-0e8652ceff6a	6
359229	azaTHIOprine 75 MG Oral Tablet	PSN	1cd03d78-d567-4449-be98-0e8652ceff6a	6
359228	azathioprine 100 MG Oral Tablet	SCD	1cd03d78-d567-4449-be98-0e8652ceff6a	6
199310	azathioprine 25 MG Oral Tablet	SCD	1cd03d78-d567-4449-be98-0e8652ceff6a	6
359229	azathioprine 75 MG Oral Tablet	SCD	1cd03d78-d567-4449-be98-0e8652ceff6a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-118-01	68382011801	100 TABLET in 1 BOTTLE (68382-118-01)	100 tablet	2017-12-02	0000-00-00	No	No	Current
68382-118-05	68382011805	500 TABLET in 1 BOTTLE (68382-118-05)	500 tablet	2017-12-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azathioprine Tablets, USP	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2024-08-02	HUMAN PRESCRIPTION DRUG LABEL	11
Azathioprine Tablets, USP	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2023-08-22	HUMAN PRESCRIPTION DRUG LABEL	6