Home NDC 68084-229 Azathioprine
Product NDC 68084-229
11-digit product format 680840229
Labeler code 68084
Product ID 68084-229_3582bd73-c190-955e-e063-6394a90a634f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azathioprine
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA077621
Marketing category ANDA
Marketing start 2008-02-22
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS 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.
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 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…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077621-001 AZATHIOPRINE 50MG TABLET / ORAL AB 2007-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077621-002 AZATHIOPRINE 25MG TABLET / ORAL AB 2008-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077621-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2008-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077621-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2008-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077621-001 AZATHIOPRINE 50MG TABLET / ORAL AB 2007-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077621-002 AZATHIOPRINE 25MG TABLET / ORAL AB 2008-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077621-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2008-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077621-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2008-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077621-001 AZATHIOPRINE 50MG TABLET / ORAL AB 2007-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077621-002 AZATHIOPRINE 25MG TABLET / ORAL AB 2008-09-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077621-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2008-09-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077621-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2008-09-05 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 68084-229-01 Azathioprine 100 in 1 CARTON TABLET 100 11 68084-229-11 Azathioprine 1 in 1 BLISTER PACK TABLET 1 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-229 AZATHIOPRINE TABLET [AMERICAN HEALTH PACKAGING] 11 Current NDC, Legacy NDC, 2 package rows 20250522_040d010a-b1b2-4db7-905d-8aa7f1bab0cd.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 · 5 matching rows.
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 68084-229-01 68084022901 100 BLISTER PACK in 1 CARTON (68084-229-01) / 1 TABLET in 1 BLISTER PACK (68084-229-11) 100 blister pack 2008-02-22 0000-00-00 No No Current 68084-229-11 68084022911 1 in 1 BLISTER PACK Historical