ALLOPURINOL

Product NDC
80425-0518
11-digit product format
804250518
Labeler code
80425
Product ID
80425-0518_36c1d44f-f581-f2ef-e063-6294a90a9f43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALLOPURINOL
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA217748
Marketing category
ANDA
Marketing start
2025-05-29
Substance
ALLOPURINOL
Active strength
300 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
63CZ7GJN5IALLOPURINOL315-30-0ALLOPURINOL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0518-18042505180130 TABLET in 1 BOTTLE (80425-0518-1) 30 tablet2025-05-29NoNoHistorical
80425-0518-28042505180260 TABLET in 1 BOTTLE (80425-0518-2) 60 tablet2025-05-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ALLOPURINOLAdvanced Rx of Tennessee, LLC2025-05-29HUMAN PRESCRIPTION DRUG LABEL1