Home NDC 85766-288-60 Allopurinol
Product NDC 85766-288
Requested package NDC 85766-288-60
11-digit product format 857660288
Labeler code 85766
Product ID 85766-288_5c99f702-23e1-6fb6-e063-6294a90aeea1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Allopurinol
Dosage form TABLET
Route ORAL
Labeler Sportpharm LLC
Application ANDA215091
Marketing category ANDA
Marketing start 2025-04-14
Substance ALLOPURINOL
Active strength 300 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 43 .
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 2026-09-14 22:38:34 2026-08 A215091-001 ALLOPURINOL 100MG TABLET / ORAL AB 2025-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215091-002 ALLOPURINOL 300MG TABLET / ORAL AB 2025-04-14 84e616aacf4f…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Allopurinol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLOPURINOL 300 mg/1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85766-288-60 85766028860 60 TABLET in 1 BOTTLE (85766-288-60) 60 tablet 2026-09-29 No No Current