Home NDC 68462-502-10 Azathioprine
Product NDC 68462-502
Requested package NDC 68462-502-10
11-digit product format 684620502
Labeler code 68462
Product ID 68462-502_26e47a7e-a3b4-036a-e063-6394a90ae208
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azathioprine
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals, Inc
Application ANDA075252
Marketing category ANDA
Marketing start 1999-08-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68462-502 68462-502-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 RLD / RS Approval date A075252-001 AZASAN AZATHIOPRINE 50MG TABLET / ORAL AB 1999-06-07 A075252-002 AZASAN AZATHIOPRINE 25MG TABLET / ORAL AB 2003-02-03 A075252-003 AZASAN AZATHIOPRINE 75MG TABLET / ORAL AB 2003-02-03 A075252-004 AZASAN AZATHIOPRINE 100MG TABLET / ORAL AB 2003-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A075252-001 AZASAN 50MG TABLET / ORAL AB 1999-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075252-002 AZASAN 25MG TABLET / ORAL AB 2003-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075252-003 AZASAN 75MG TABLET / ORAL AB 2003-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075252-004 AZASAN 100MG TABLET / ORAL AB 2003-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075252-001 AZASAN 50MG TABLET / ORAL AB 1999-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075252-002 AZASAN 25MG TABLET / ORAL AB 2003-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075252-003 AZASAN 75MG TABLET / ORAL AB 2003-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075252-004 AZASAN 100MG TABLET / ORAL AB 2003-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075252-001 AZASAN 50MG TABLET / ORAL AB 1999-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075252-002 AZASAN 25MG TABLET / ORAL AB 2003-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075252-003 AZASAN 75MG TABLET / ORAL AB 2003-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075252-004 AZASAN 100MG TABLET / ORAL AB 2003-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075252-001 AZASAN 50MG TABLET / ORAL AB 1999-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075252-002 AZASAN 25MG TABLET / ORAL AB 2003-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075252-003 AZASAN 75MG TABLET / ORAL AB 2003-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075252-004 AZASAN 100MG TABLET / ORAL AB 2003-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075252-001 AZASAN 50MG TABLET / ORAL AB 1999-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075252-002 AZASAN 25MG TABLET / ORAL AB 2003-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075252-003 AZASAN 75MG TABLET / ORAL AB 2003-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075252-004 AZASAN 100MG TABLET / ORAL AB 2003-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075252-001 AZASAN 50MG TABLET / ORAL AB 1999-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075252-002 AZASAN 25MG TABLET / ORAL AB 2003-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075252-003 AZASAN 75MG TABLET / ORAL AB 2003-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075252-004 AZASAN 100MG TABLET / ORAL AB 2003-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075252-001 AZASAN 50MG TABLET / ORAL AB 1999-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075252-002 AZASAN 25MG TABLET / ORAL AB 2003-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075252-003 AZASAN 75MG TABLET / ORAL AB 2003-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075252-004 AZASAN 100MG TABLET / ORAL AB 2003-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075252-001 AZASAN 50MG TABLET / ORAL AB 1999-06-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075252-002 AZASAN 25MG TABLET / ORAL AB 2003-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075252-003 AZASAN 75MG TABLET / ORAL AB 2003-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075252-004 AZASAN 100MG TABLET / ORAL AB 2003-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075252-001 AZASAN 50MG TABLET / ORAL AB 1999-06-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075252-002 AZASAN 25MG TABLET / ORAL AB 2003-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075252-003 AZASAN 75MG TABLET / ORAL AB 2003-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075252-004 AZASAN 100MG TABLET / ORAL AB 2003-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075252-001 AZASAN 50MG TABLET / ORAL AB 1999-06-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075252-002 AZASAN 25MG TABLET / ORAL AB 2003-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075252-003 AZASAN 75MG TABLET / ORAL AB 2003-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075252-004 AZASAN 100MG TABLET / ORAL AB 2003-02-03 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 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 68462-502-01 Azathioprine 100 in 1 BOTTLE TABLET 100 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZATHIOPRINE ACTIVE INGREDIENT MRK240IY2L AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] 1 AZATHIOPRINE ACTIVE MOIETY MRK240IY2L AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-502 AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] 36 Current NDC, Legacy NDC, 1 package rows 20241208_ceab8e8b-d022-4d0c-a552-cc5782446248.zip 68462-502 AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] 11 Current NDC, Legacy NDC 20220922_200ce996-da00-5be7-e054-00144ff8d46c.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Azathioprine AZATHIOPRINE Oceanside Pharmaceuticals d72ede2c-1a9b-4717-80a7-b76a6a499936 2025-09-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075252 application number: ANDA075252 Azasan AZATHIOPRINE Salix Pharmaceuticals 9050af7a-19c6-4670-937a-9445605de995 2025-09-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075252 application number: ANDA075252 Azathioprine AZATHIOPRINE Golden State Medical Supply, Inc. 8429e025-b79d-dae7-e053-2a91aa0a7fe5 2025-01-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075252 application number: ANDA075252 Azathioprine AZATHIOPRINE Glenmark Pharmaceuticals, Inc ceab8e8b-d022-4d0c-a552-cc5782446248 2024-11-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075252 application number: ANDA075252 ndc (product): 68462-502
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68462-502-10 68462050210 100 TABLET in 1 BOTTLE (68462-502-10) 100 tablet 1999-08-01 2027-01-01 No No Current