FDA.reportPublic FDA data

FEBUXOSTAT

Product NDC
43547-295
11-digit product format
435470295
Labeler code
43547
Product ID
43547-295_7125d234-570f-4c51-8e72-8202f4dc299b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US LLC
Application
ANDA206266
Marketing category
ANDA
Marketing start
2023-08-01
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
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
43547-295-03FEBUXOSTAT30 in 1 BOTTLETABLET307
43547-295-09FEBUXOSTAT90 in 1 BOTTLETABLET907
43547-295-50FEBUXOSTAT500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-295-03EA - Each43547-295ced59c68-17a9-4555-aaa9-d5a4fd46c49612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-295FEBUXOSTAT TABLET [SOLCO HEALTHCARE US LLC]7Current NDC, Legacy NDC, 3 package rows20250328_4f5f8f2b-7200-4d76-9049-11dbc6cbd2ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN4f5f8f2b-7200-4d76-9049-11dbc6cbd2ca7
834241febuxostat 80 MG Oral TabletPSN4f5f8f2b-7200-4d76-9049-11dbc6cbd2ca7
834235febuxostat 40 MG Oral TabletSCD4f5f8f2b-7200-4d76-9049-11dbc6cbd2ca7
834241febuxostat 80 MG Oral TabletSCD4f5f8f2b-7200-4d76-9049-11dbc6cbd2ca7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-295-034354702950330 TABLET in 1 BOTTLE (43547-295-03) 30 tablet2023-08-010000-00-00NoNoCurrent
43547-295-094354702950990 TABLET in 1 BOTTLE (43547-295-09) 90 tablet2023-08-010000-00-00NoNoCurrent
43547-295-5043547029550500 TABLET in 1 BOTTLE (43547-295-50) 500 tablet2023-08-010000-00-00NoNoCurrent