Home NDC 71610-306 Azathioprine
Product NDC 71610-306
11-digit product format 716100306
Labeler code 71610
Product ID 71610-306_bd093207-b2c0-4518-a78c-2568673f0bdd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azathioprine
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075252
Marketing category ANDA
Marketing start 1999-06-07
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71610-306-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71610-306-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71610-306-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71610-306-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71610-306-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71610-306-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71610-306-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71610-306-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71610-306-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 71610-306-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 71610-306-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 71610-306-60 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 71610-306-60 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 71610-306-60 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71610-306-60 1332a3947898…d4bfe170f9cd…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-306-60 Azathioprine 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-306 AZATHIOPRINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 1 package rows 20190718_91461b02-75d1-4f44-9a8a-a8b8080e6165.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
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 71610-306-60 71610030660 90 TABLET in 1 BOTTLE (71610-306-60) 90 tablet 2019-07-16 0000-00-00 No No Current