Home NDC 0378-1005-01 Azathioprine
Product NDC 0378-1005
Requested package NDC 0378-1005-01
11-digit product format 003781005
Labeler code 0378
Product ID 0378-1005_6cf60af7-780e-4d86-aa30-f84dba65c02e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azathioprine
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA075568
Marketing category ANDA
Marketing start 2009-12-28
Marketing end 2022-04-30
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 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075568-001 AZATHIOPRINE AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075568-001 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 2 · 41 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 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# 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 Rising Pharma Holdings, Inc. 2ffa2fce-895d-469e-8667-b078560aec5f 2025-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075568 application number: ANDA075568
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 0378-1005-01 00378100501 100 TABLET in 1 BOTTLE, PLASTIC (0378-1005-01) 100 tablet 2009-12-28 2022-04-30 No No Current