FDA.reportPublic FDA data

Febuxostat

Product NDC
47335-721
11-digit product format
473350721
Labeler code
47335
Product ID
47335-721_53dfe063-e9bf-4069-b4cc-5a83a27d18ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Febuxostat
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205467
Marketing category
ANDA
Marketing start
2019-07-05
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

Additional Listing Data#

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

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-721-13Febuxostat500 in 1 BOTTLETABLET, FILM COATED5005
47335-721-81Febuxostat90 in 1 BOTTLETABLET, FILM COATED905
47335-721-83Febuxostat30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-721-83EA - Each47335-721ea0b5b8c-0d56-42dc-be3c-7e7bad3180fa12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-721FEBUXOSTAT TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 3 package rows20231107_1f7541bd-bf32-422b-b99a-89193cf193ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN1f7541bd-bf32-422b-b99a-89193cf193ca5
834241febuxostat 80 MG Oral TabletPSN1f7541bd-bf32-422b-b99a-89193cf193ca5
834235febuxostat 40 MG Oral TabletSCD1f7541bd-bf32-422b-b99a-89193cf193ca5
834241febuxostat 80 MG Oral TabletSCD1f7541bd-bf32-422b-b99a-89193cf193ca5
834235febuxostat 40 MG Oral TabletPSN14f80ad5-37cc-4672-9caa-2dd2f469af0a2
834235febuxostat 40 MG Oral TabletSCD14f80ad5-37cc-4672-9caa-2dd2f469af0a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-721-1347335072113500 TABLET, FILM COATED in 1 BOTTLE (47335-721-13) 2019-07-050000-00-00NoNoCurrent
47335-721-814733507218190 TABLET, FILM COATED in 1 BOTTLE (47335-721-81) 2019-07-050000-00-00NoNoCurrent
47335-721-834733507218330 TABLET, FILM COATED in 1 BOTTLE (47335-721-83) 2019-07-050000-00-00NoNoCurrent