FEBUXOSTAT

Product NDC
72303-0855
11-digit product format
723030855
Labeler code
72303
Product ID
72303-0855_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
40 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

Additional Listing Data#

Finished product
Yes
Brand name base
FEBUXOSTAT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEBUXOSTAT40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii101V0R1N2E
Rxcui834235, 834241

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
253cf2a8-e060-f2e5-7334-8565436b95e4Product name620240213

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72303-0855-1FEBUXOSTAT30 in 1 BOTTLETABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN4f1d0452-e041-cda6-e063-6394a90a2aef1
834241febuxostat 80 MG Oral TabletPSN4f1d0452-e041-cda6-e063-6394a90a2aef1
834235febuxostat 40 MG Oral TabletSCD4f1d0452-e041-cda6-e063-6394a90a2aef1
834241febuxostat 80 MG Oral TabletSCD4f1d0452-e041-cda6-e063-6394a90a2aef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72303-0855-17230308550130 TABLET in 1 BOTTLE (72303-0855-1) 30 tablet2026-04-10NoNoCurrent