Home NDC 0054-4582 MERCAPTOPURINE
Product NDC 0054-4582
11-digit product format 000544582
Labeler code 0054
Product ID 0054-4582_7b9eba74-503d-4704-94e9-d52e8701c7bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MERCAPTOPURINE
Dosage form SUSPENSION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA216418
Marketing category ANDA
Marketing start 2025-02-26
Marketing end 2026-12-31
Substance MERCAPTOPURINE
Active strength 20 mg/mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
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 A216418-001 MERCAPTOPURINE MERCAPTOPURINE 20MG/ML SUSPENSION / ORAL AB 2025-02-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216418-001 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.
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 A216418-001 MERCAPTOPURINE 20MG/ML SUSPENSION / ORAL AB 2025-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216418-001 MERCAPTOPURINE 20MG/ML SUSPENSION / ORAL AB 2025-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216418-001 MERCAPTOPURINE 20MG/ML SUSPENSION / ORAL AB 2025-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216418-001 MERCAPTOPURINE 20MG/ML SUSPENSION / ORAL AB 2025-02-26 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216418-001 MERCAPTOPURINE 20MG/ML SUSPENSION / ORAL AB 2025-02-26 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216418-001 CGT 2025-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216418-001 CGT 2025-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216418-001 CGT 2025-08-25 fd3edfee7708…
Additional Listing Data#
Finished product Yes
Brand name base MERCAPTOPURINE Active Ingredients# Ingredient, Strength table Ingredient Strength MERCAPTOPURINE 20 mg/mL
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 1536484 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 0054-4582-49 MERCAPTOPURINE 1 in 1 CARTON SUSPENSION 1 4 0054-4582-49 MERCAPTOPURINE 100 mL in 1 BOTTLE, GLASS SUSPENSION 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-4582 MERCAPTOPURINE SUSPENSION [HIKMA PHARMACEUTICALS USA INC.] 3 Current NDC, 2 package rows 20250302_25b39be7-fe1e-efe6-e063-6294a90a6e8d.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 Marketing start Marketing end Sample Exclude flag Status 0054-4582-49 00054458249 1 BOTTLE, GLASS in 1 CARTON (0054-4582-49) / 100 mL in 1 BOTTLE, GLASS 2025-02-26 2026-12-31 No No Historical