Home NDC 67877-495 Azathioprine
Product NDC 67877-495
11-digit product format 678770495
Labeler code 67877
Product ID 67877-495_7fdec2f6-c3b5-483f-8bfc-0afb292781da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azathioprine
Dosage form TABLET
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA208687
Marketing category ANDA
Marketing start 2020-03-29
Substance AZATHIOPRINE
Active strength 100 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 A208687-001 AZATHIOPRINE AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 A208687-002 AZATHIOPRINE AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 A208687-003 AZATHIOPRINE AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 A208687-004 AZATHIOPRINE AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27
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 4 · 148 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 A208687-001 AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208687-002 AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208687-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208687-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208687-001 AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208687-002 AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208687-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208687-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208687-001 AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208687-002 AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208687-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208687-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208687-001 AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208687-002 AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208687-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208687-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208687-001 AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208687-002 AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208687-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208687-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208687-001 AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208687-002 AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208687-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208687-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208687-001 AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208687-002 AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208687-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208687-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208687-001 AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208687-002 AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208687-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208687-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208687-001 AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208687-002 AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208687-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208687-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208687-001 AZATHIOPRINE 25MG TABLET / ORAL AB 2020-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208687-002 AZATHIOPRINE 50MG TABLET / ORAL AB 2020-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208687-003 AZATHIOPRINE 75MG TABLET / ORAL AB 2020-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208687-004 AZATHIOPRINE 100MG TABLET / ORAL AB 2020-03-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 148 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 100 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197388 Internal RxNorm lookup 199310 Internal RxNorm lookup 359228 Internal RxNorm lookup 359229 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 67877-495-01 Azathioprine 100 in 1 BOTTLE TABLET 100 9 67877-495-05 Azathioprine 500 in 1 BOTTLE TABLET 500 9 67877-495-10 Azathioprine 1000 in 1 BOTTLE TABLET 1000 9 67877-495-33 Azathioprine 10 in 1 BLISTER PACK TABLET 10 9 67877-495-38 Azathioprine 10 in 1 CARTON TABLET 10 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-495 AZATHIOPRINE TABLET [ASCEND LABORATORIES, LLC] 9 Current NDC, Legacy NDC, 5 package rows 20250425_bc6dc4bd-2121-4613-9d90-4a504010c98a.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Azathioprine AZATHIOPRINE NuCare Pharmaceuticals,Inc. 5116b22b-1460-5535-e063-6394a90acbe5 2026-05-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208687 application number: ANDA208687 Azathioprine AZATHIOPRINE REMEDYREPACK INC. f251f372-c881-483e-8035-c6a8a6bfb4e8 2026-04-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208687 application number: ANDA208687 Azathioprine AZATHIOPRINE Ascend Laboratories, LLC bc6dc4bd-2121-4613-9d90-4a504010c98a 2025-04-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208687 application number: ANDA208687 ndc (product): 67877-495
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 67877-495-01 67877049501 100 TABLET in 1 BOTTLE (67877-495-01) 100 tablet 2020-03-29 0000-00-00 No No Current 67877-495-05 67877049505 500 TABLET in 1 BOTTLE (67877-495-05) 500 tablet 2020-03-29 0000-00-00 No No Current 67877-495-10 67877049510 1000 TABLET in 1 BOTTLE (67877-495-10) 1000 tablet 2020-03-29 0000-00-00 No No Current 67877-495-33 67877049533 10 in 1 BLISTER PACK Historical 67877-495-38 67877049538 10 BLISTER PACK in 1 CARTON (67877-495-38) / 10 TABLET in 1 BLISTER PACK (67877-495-33) 10 blister pack 2020-03-29 0000-00-00 No No Current