FDA.reportPublic FDA data

Febuxostat

Product NDC
59651-114
11-digit product format
596510114
Labeler code
59651
Product ID
59651-114_b76fce08-5430-4285-8a39-b689c97afe29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Febuxostat
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA210741
Marketing category
ANDA
Marketing start
2023-10-25
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-114-01Febuxostat100 in 1 BOTTLETABLET1002
59651-114-05Febuxostat500 in 1 BOTTLETABLET5002
59651-114-30Febuxostat30 in 1 BOTTLETABLET302
59651-114-90Febuxostat90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-114-30EA - Each59651-1147dc870f1-dce1-42c5-9d2b-f82879bc809712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-114FEBUXOSTAT TABLET [AUROBINDO PHARMA LIMITED]2Current NDC, 4 package rows20240509_04f80eb2-8171-4e18-93e4-514440e84b75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN04f80eb2-8171-4e18-93e4-514440e84b752
834241febuxostat 80 MG Oral TabletPSN04f80eb2-8171-4e18-93e4-514440e84b752
834235febuxostat 40 MG Oral TabletSCD04f80eb2-8171-4e18-93e4-514440e84b752
834241febuxostat 80 MG Oral TabletSCD04f80eb2-8171-4e18-93e4-514440e84b752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-114-0159651011401100 TABLET in 1 BOTTLE (59651-114-01) 100 tablet2023-10-25NoNoHistorical
59651-114-0559651011405500 TABLET in 1 BOTTLE (59651-114-05) 500 tablet2023-10-25NoNoHistorical
59651-114-305965101143030 TABLET in 1 BOTTLE (59651-114-30) 30 tablet2023-10-25NoNoHistorical
59651-114-905965101149090 TABLET in 1 BOTTLE (59651-114-90) 90 tablet2023-10-25NoNoHistorical