Home NDC 0054-4581 Mercaptopurine
Product NDC 0054-4581
11-digit product format 000544581
Labeler code 0054
Product ID 0054-4581_564261a6-c6b6-4d31-bf80-36fe086e73e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mercaptopurine
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA040528
Marketing category ANDA
Marketing start 2004-02-13
Substance MERCAPTOPURINE
Active strength 50 mg/1
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040528-001 MERCAPTOPURINE MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040528-001 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 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040528-001 MERCAPTOPURINE 50MG TABLET / ORAL AB RS 2004-02-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Mercaptopurine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MERCAPTOPURINE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination E7WED276I5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197931 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 0054-4581-11 Mercaptopurine 25 in 1 BOTTLE, PLASTIC TABLET 25 14 0054-4581-27 Mercaptopurine 250 in 1 BOTTLE, PLASTIC TABLET 250 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MERCAPTOPURINE ACTIVE INGREDIENT E7WED276I5 MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] 6 MERCAPTOPURINE ANHYDROUS ACTIVE MOIETY PKK6MUZ20G MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] 6 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] 6 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] 6 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MERCAPTOPURINE TABLET [ROXANE LABORATORIES, INC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-4581 MERCAPTOPURINE TABLET [HIKMA PHARMACEUTICALS USA INC.] 14 Current NDC, Legacy NDC, 2 package rows 20250315_c3b5b8b0-bc5c-4ce9-bbdc-febba60c2658.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 · 2 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 0054-4581-11 00054458111 25 TABLET in 1 BOTTLE, PLASTIC (0054-4581-11) 25 tablet 2004-02-13 0000-00-00 No No Current 0054-4581-27 00054458127 250 TABLET in 1 BOTTLE, PLASTIC (0054-4581-27) 250 tablet 2004-02-13 0000-00-00 No No Current