Azathioprine Tablets, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 21:18:16

Label at a glance#

ProductAzathioprine

Active ingredientAZATHIOPRINE

Label structure3 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1140-1 in bottle of 100 tablets

Azathioprine Tablets USP, 75 mg

100 tablets

Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1141-1 in bottle of 100 tablets

Azathioprine Tablets USP, 100 mg

100 tablets

Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1139-1 in bottle of 100 tablets

Azathioprine Tablets USP, 25 mg

100 tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
359228	azaTHIOprine 100 MG Oral Tablet	PSN	6
199310	azaTHIOprine 25 MG Oral Tablet	PSN	6
359229	azaTHIOprine 75 MG Oral Tablet	PSN	6
359228	azathioprine 100 MG Oral Tablet	SCD	6
199310	azathioprine 25 MG Oral Tablet	SCD	6
359229	azathioprine 75 MG Oral Tablet	SCD	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
AZATHIOPRINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20200302

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
70771-1139-1	Azathioprine	100 in 1 BOTTLE	TABLET	100	6
70771-1139-5	Azathioprine	500 in 1 BOTTLE	TABLET	500	6
70771-1140-1	Azathioprine	100 in 1 BOTTLE	TABLET	100	6
70771-1140-5	Azathioprine	500 in 1 BOTTLE	TABLET	500	6
70771-1141-1	Azathioprine	100 in 1 BOTTLE	TABLET	100	6
70771-1141-5	Azathioprine	500 in 1 BOTTLE	TABLET	500	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1139	AZATHIOPRINE TABLET [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 2 package rows	20241128_89b272f0-ef5c-49e4-820f-fcd7ea8ef066.zip
70771-1140	AZATHIOPRINE TABLET [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 2 package rows	20241128_89b272f0-ef5c-49e4-820f-fcd7ea8ef066.zip
70771-1141	AZATHIOPRINE TABLET [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 2 package rows	20241128_89b272f0-ef5c-49e4-820f-fcd7ea8ef066.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Azathioprine
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1139	70771-1139-1, 70771-1139-5
70771-1140	70771-1140-1, 70771-1140-5
70771-1141	70771-1141-1, 70771-1141-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AZATHIOPRINE	MRK240IY2L	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
AZATHIOPRINE	MRK240IY2L	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
AZATHIOPRINE	MRK240IY2L	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

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 · 176 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	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077621-001	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2007-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077621-002	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2008-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077621-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2008-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077621-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2008-09-05	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077621-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077621-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077621-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077621-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077621-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077621-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077621-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077621-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077621-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077621-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077621-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077621-004	AB	1	`caaa826d4ba7…`
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…`

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	Zydus Lifesciences Limited	89b272f0-ef5c-49e4-820f-fcd7ea8ef066	2024-11-25		Exact identifier ndc (package): 70771-1141-1 ndc (package): 70771-1139-5 ndc (package): 70771-1140-1 ndc (package): 70771-1139-1 ndc (package): 70771-1140-5 ndc (package): 70771-1141-5 ndc (product): 70771-1140 ndc (product): 70771-1139 ndc (product): 70771-1141 ndc11 (package): 70771114105 ndc11 (package): 70771114101 ndc11 (package): 70771113905 ndc11 (package): 70771114001 ndc11 (package): 70771114005 ndc11 (package): 70771113901 spl id: 1277f50f-59f8-4c65-88de-011424884c3b spl set id: 89b272f0-ef5c-49e4-820f-fcd7ea8ef066

Reported adverse events (FAERS/openFDA)#

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