FDA.reportPublic FDA data

Febuxostat

Product NDC
62332-191
11-digit product format
623320191
Labeler code
62332
Product ID
62332-191_d93f60e8-39b0-4359-9aaa-2e02ac188b1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
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
62332-191-06Febuxostat60 in 1 CARTONTABLET, COATED607
62332-191-10Febuxostat100 in 1 CARTONTABLET, COATED1007
62332-191-30Febuxostat30 in 1 BOTTLETABLET, COATED307
62332-191-31Febuxostat100 in 1 BOTTLETABLET, COATED1007
62332-191-91Febuxostat1000 in 1 BOTTLETABLET, COATED10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-191-30EA - Each62332-19114e74155-b85a-463a-b2e1-d172e3eb9cb512019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-191FEBUXOSTAT TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 5 package rows20230630_9a87099f-d82d-42c7-872a-b87d3917e960.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN9a87099f-d82d-42c7-872a-b87d3917e9607
834241febuxostat 80 MG Oral TabletPSN9a87099f-d82d-42c7-872a-b87d3917e9607
834235febuxostat 40 MG Oral TabletSCD9a87099f-d82d-42c7-872a-b87d3917e9607
834241febuxostat 80 MG Oral TabletSCD9a87099f-d82d-42c7-872a-b87d3917e9607

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-191-066233201910660 TABLET, COATED in 1 CARTON (62332-191-06) 2019-07-010000-00-00NoNoCurrent
62332-191-1062332019110100 TABLET, COATED in 1 CARTON (62332-191-10) 2019-07-010000-00-00NoNoCurrent
62332-191-306233201913030 TABLET, COATED in 1 BOTTLE (62332-191-30) 2019-07-010000-00-00NoNoCurrent
62332-191-3162332019131100 TABLET, COATED in 1 BOTTLE (62332-191-31) 2019-07-010000-00-00NoNoCurrent
62332-191-91623320191911000 TABLET, COATED in 1 BOTTLE (62332-191-91) 2019-07-010000-00-00NoNoCurrent