Allopurinol

Product NDC
71610-681
11-digit product format
716100681
Labeler code
71610
Product ID
71610-681_fe21f4f9-59eb-4885-90b5-c2859a714516
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204467
Marketing category
ANDA
Marketing start
2022-03-01
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
71610-681-457161006814545 TABLET in 1 BOTTLE (71610-681-45) 45 tablet2022-12-13NoNoHistorical
71610-681-607161006816090 TABLET in 1 BOTTLE (71610-681-60) 90 tablet2022-12-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ALLOPURINOL TABLETS USP 100 mg and 300 mg Rx OnlyAphena Pharma Solutions - Tennessee, LLC2022-12-13Human Prescription Drug Label1