febuxostat

Product NDC
68071-3760
11-digit product format
680713760
Labeler code
68071
Product ID
68071-3760_2b5d52a3-c025-680f-e063-6394a90aca3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA205443
Marketing category
ANDA
Marketing start
2023-03-31
Substance
FEBUXOSTAT
Active strength
40 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
101V0R1N2EFEBUXOSTAT144060-53-7FEBUXOSTAT

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3760-96807137600990 TABLET in 1 BOTTLE (68071-3760-9) 90 tablet2025-01-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
febuxostatNuCare Pharmaceuticals, Inc.2025-01-10HUMAN PRESCRIPTION DRUG LABEL1