FEBUXOSTAT

Product NDC
72303-0856
11-digit product format
723030856
Labeler code
72303
Product ID
72303-0856_4f1d0d50-8032-d895-e063-6394a90a9bb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET
Route
ORAL
Labeler
HEC Pharm USA Inc.
Application
ANDA213069
Marketing category
ANDA
Marketing start
2026-04-10
Substance
FEBUXOSTAT
Active strength
80 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
101V0R1N2EFEBUXOSTAT144060-53-7FEBUXOSTAT

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72303-0856-17230308560130 TABLET in 1 BOTTLE (72303-0856-1) 30 tablet2026-04-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FEBUXOSTATHEC Pharm USA Inc. | Sunshine Lake Pharma Co., Ltd.2026-03-10HUMAN PRESCRIPTION DRUG LABEL1