Home NDC 59651-285 Allopurinol
Product NDC 59651-285
11-digit product format 596510285
Labeler code 59651
Product ID 59651-285_ef67cf70-5cf4-4b0d-86a5-c5af60228180
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Allopurinol
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA215091
Marketing category ANDA
Marketing start 2025-04-14
Substance ALLOPURINOL
Active strength 100 mg/1
Pharmacologic classes Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215091-001 ALLOPURINOL ALLOPURINOL 100MG TABLET / ORAL AB 2025-04-14 A215091-002 ALLOPURINOL ALLOPURINOL 300MG TABLET / ORAL AB 2025-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 2026-08-18 06:07:40 2026-07 A215091-001 ALLOPURINOL 100MG TABLET / ORAL AB 2025-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215091-002 ALLOPURINOL 300MG TABLET / ORAL AB 2025-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215091-001 ALLOPURINOL 100MG TABLET / ORAL AB 2025-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215091-002 ALLOPURINOL 300MG TABLET / ORAL AB 2025-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215091-001 ALLOPURINOL 100MG TABLET / ORAL AB 2025-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215091-002 ALLOPURINOL 300MG TABLET / ORAL AB 2025-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215091-001 ALLOPURINOL 100MG TABLET / ORAL AB 2025-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215091-002 ALLOPURINOL 300MG TABLET / ORAL AB 2025-04-14 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215091-001 ALLOPURINOL 100MG TABLET / ORAL AB 2025-04-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215091-002 ALLOPURINOL 300MG TABLET / ORAL AB 2025-04-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Allopurinol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLOPURINOL 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 63CZ7GJN5I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197319 Internal RxNorm lookup 197320 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 59651-285-01 Allopurinol 100 in 1 BOTTLE TABLET 100 2 59651-285-99 Allopurinol 1000 in 1 BOTTLE TABLET 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-285 ALLOPURINOL TABLET [AUROBINDO PHARMA LIMITED] 1 Current NDC, 2 package rows 20250424_311ca755-c022-4251-97eb-dd9be86a993f.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-285-01 59651028501 100 TABLET in 1 BOTTLE (59651-285-01) 100 tablet 2025-04-14 No No Current 59651-285-99 59651028599 1000 TABLET in 1 BOTTLE (59651-285-99) 1000 tablet 2025-04-14 No No Current