Allopurinol

Product NDC
67544-313
11-digit product format
675440313
Labeler code
67544
Product ID
67544-313_c5d95534-5585-40ff-9d6c-8b4a62c1b101
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA018877
Marketing category
NDA
Marketing start
2009-04-06
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
67544-313-456754403134545 TABLET in 1 BOTTLE, PLASTIC (67544-313-45) 45 tablet2022-12-21NoNoHistorical
67544-313-606754403136090 TABLET in 1 BOTTLE, PLASTIC (67544-313-60) 90 tablet2022-12-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Allopurinol Tablets USP Rx onlyAphena Pharma Solutions - Tennessee, LLC2022-12-21HUMAN PRESCRIPTION DRUG LABEL1