Febuxostat

Product NDC
71610-585
11-digit product format
716100585
Labeler code
71610
Product ID
71610-585_2f9f373e-d40d-4163-90a9-f53b7eb24cd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210292
Marketing category
ANDA
Marketing start
2020-09-28
Marketing end
0000-00-00
Substance
FEBUXOSTAT
Active strength
40 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
253cf2a8-e060-f2e5-7334-8565436b95e4Product name620240213

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-585-60Febuxostat90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-585-60EA - Each71610-5859b64c26e-0779-4bf6-99bf-3734984c45d012021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-585FEBUXOSTAT TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20210811_8ed19d23-b91c-4e5a-b1c5-24e355b8c0a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN8ed19d23-b91c-4e5a-b1c5-24e355b8c0a41
834235febuxostat 40 MG Oral TabletSCD8ed19d23-b91c-4e5a-b1c5-24e355b8c0a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-585-607161005856090 TABLET in 1 BOTTLE (71610-585-60) 90 tablet2021-07-260000-00-00NoNoCurrent