FDA.reportPublic FDA data

Febuxostat

Product NDC
60687-538
11-digit product format
606870538
Labeler code
60687
Product ID
60687-538_102d1826-981f-0ebc-e063-6294a90a4acc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Febuxostat
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA205467
Marketing category
ANDA
Marketing start
2021-09-02
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

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
60687-538-11Febuxostat1 in 1 BLISTER PACKTABLET, FILM COATED12
60687-538-21Febuxostat30 in 1 BOX, UNIT-DOSETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-538-11EA - Each60687-538089a75ef-d3bb-4504-98ef-837533a9c60912021-09-07
60687-538-21EA - Each60687-538a5a08f90-8768-4bd0-b532-455e204a757312021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-538FEBUXOSTAT TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2Current NDC, Legacy NDC, 2 package rows20240131_14f80ad5-37cc-4672-9caa-2dd2f469af0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-538-11606870538111 in 1 BLISTER PACKHistorical
60687-538-216068705382130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-538-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-538-11) 30 blister pack2021-09-020000-00-00NoNoCurrent