FDA.reportPublic FDA data

Febuxostat

Product NDC
46708-191
11-digit product format
467080191
Labeler code
46708
Product ID
46708-191_1d0ffd95-5afe-4f03-8ac9-706187144e98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA205421
Marketing category
ANDA
Marketing start
2019-07-01
Substance
FEBUXOSTAT
Active strength
80 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

Additional Listing Data#

Finished product
Yes
Brand name base
Febuxostat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEBUXOSTAT80 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
46708-191-06Febuxostat60 in 1 CARTONTABLET, COATED602
46708-191-10Febuxostat100 in 1 CARTONTABLET, COATED1002
46708-191-30Febuxostat30 in 1 BOTTLETABLET, COATED302
46708-191-31Febuxostat100 in 1 BOTTLETABLET, COATED1002
46708-191-91Febuxostat1000 in 1 BOTTLETABLET, COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-191FEBUXOSTAT TABLET, COATED [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 5 package rows20230120_41a95424-046e-413b-a121-cd7335e67135.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN41a95424-046e-413b-a121-cd7335e671352
834241febuxostat 80 MG Oral TabletPSN41a95424-046e-413b-a121-cd7335e671352
834235febuxostat 40 MG Oral TabletSCD41a95424-046e-413b-a121-cd7335e671352
834241febuxostat 80 MG Oral TabletSCD41a95424-046e-413b-a121-cd7335e671352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-191-064670801910660 TABLET, COATED in 1 CARTON (46708-191-06) 2019-07-010000-00-00NoNoCurrent
46708-191-1046708019110100 TABLET, COATED in 1 CARTON (46708-191-10) 2019-07-010000-00-00NoNoCurrent
46708-191-304670801913030 TABLET, COATED in 1 BOTTLE (46708-191-30) 2019-07-010000-00-00NoNoCurrent
46708-191-3146708019131100 TABLET, COATED in 1 BOTTLE (46708-191-31) 2019-07-010000-00-00NoNoCurrent
46708-191-91467080191911000 TABLET, COATED in 1 BOTTLE (46708-191-91) 2019-07-010000-00-00NoNoCurrent