FDA.reportPublic FDA data

febuxostat

Product NDC
72578-137
11-digit product format
725780137
Labeler code
72578
Product ID
72578-137_082ca5b7-ccb9-4096-a363-a188d6f51586
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA205443
Marketing category
ANDA
Marketing start
2023-03-31
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
72578-137-01febuxostat100 in 1 BOTTLETABLET1002
72578-137-05febuxostat500 in 1 BOTTLETABLET5002
72578-137-06febuxostat30 in 1 BOTTLETABLET302
72578-137-10febuxostat1000 in 1 BOTTLETABLET10002
72578-137-16febuxostat90 in 1 BOTTLETABLET902
72578-137-77febuxostat10 in 1 CARTONTABLET102
72578-137-77febuxostat10 in 1 BLISTER PACKTABLET102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-137-06EA - Each72578-137d2eb9116-3805-4ffa-9542-7add584fa5ff12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-137FEBUXOSTAT TABLET [VIONA PHARMACEUTICALS INC]2Current NDC, 7 package rows20230524_b2aeb900-d792-48b2-b678-94f82d68be32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSNb2aeb900-d792-48b2-b678-94f82d68be322
834241febuxostat 80 MG Oral TabletPSNb2aeb900-d792-48b2-b678-94f82d68be322
834235febuxostat 40 MG Oral TabletSCDb2aeb900-d792-48b2-b678-94f82d68be322
834241febuxostat 80 MG Oral TabletSCDb2aeb900-d792-48b2-b678-94f82d68be322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-137-0172578013701100 TABLET in 1 BOTTLE (72578-137-01) 100 tablet2023-03-31NoNoHistorical
72578-137-0572578013705500 TABLET in 1 BOTTLE (72578-137-05) 500 tablet2023-03-31NoNoHistorical
72578-137-067257801370630 TABLET in 1 BOTTLE (72578-137-06) 30 tablet2023-03-31NoNoHistorical
72578-137-10725780137101000 TABLET in 1 BOTTLE (72578-137-10) 1000 tablet2023-03-31NoNoHistorical
72578-137-167257801371690 TABLET in 1 BOTTLE (72578-137-16) 90 tablet2023-03-31NoNoHistorical
72578-137-777257801377710 BLISTER PACK in 1 CARTON (72578-137-77) / 10 TABLET in 1 BLISTER PACK10 blister pack2023-03-31NoNoHistorical