Home NDC 69238-1076 AZATHIOPRINE
Product NDC 69238-1076
11-digit product format 692381076
Labeler code 69238
Product ID 69238-1076_d4549001-c251-4461-b3ff-5d25e9243918
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azathioprine
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA074069
Marketing category ANDA
Marketing start 2015-02-02
Substance AZATHIOPRINE
Active strength 50 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS 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.
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 RLD / RS 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.
Additional Listing Data#
Finished product Yes
Brand name base AZATHIOPRINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZATHIOPRINE 50 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 197388 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69238-1076-1 AZATHIOPRINE 100 in 1 BOTTLE TABLET 100 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZATHIOPRINE ACTIVE INGREDIENT MRK240IY2L AZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 2 AZATHIOPRINE ACTIVE MOIETY MRK240IY2L AZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK AZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E AZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP AZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1076 AZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS NY LLC] 5 Current NDC, Legacy NDC, 1 package rows 20231115_c49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c.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 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 ndc (product): 69238-1076 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69238-1076-1 69238107601 100 TABLET in 1 BOTTLE (69238-1076-1) 100 tablet 2015-02-02 No No Current