FEBUXOSTAT

Product NDC
0527-2248
11-digit product format
005272248
Labeler code
0527
Product ID
0527-2248_0f0d0dad-f491-e7e1-e063-6294a90a1e13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA213069
Marketing category
ANDA
Marketing start
2020-06-02
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
0527-2248-32FEBUXOSTAT30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-2248-32EA - Each0527-22480eb94dc1-661f-4e18-b946-a30b72e03c2d12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-2248FEBUXOSTAT TABLET [LANNETT COMPANY, INC.]6Current NDC, Legacy NDC, 1 package rows20240125_73b07a94-c044-42dc-abe4-7d7c860c9638.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN73b07a94-c044-42dc-abe4-7d7c860c96386
834241febuxostat 80 MG Oral TabletPSN73b07a94-c044-42dc-abe4-7d7c860c96386
834235febuxostat 40 MG Oral TabletSCD73b07a94-c044-42dc-abe4-7d7c860c96386
834241febuxostat 80 MG Oral TabletSCD73b07a94-c044-42dc-abe4-7d7c860c96386

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-2248-320052722483230 TABLET in 1 BOTTLE (0527-2248-32) 30 tablet2020-06-020000-00-00NoNoCurrent