FDA.reportPublic FDA data

Febuxostat

Product NDC
14445-157
11-digit product format
144450157
Labeler code
14445
Product ID
14445-157_60d6e78a-98f8-4968-ad5f-37689cc2c096
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Febuxostat
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA210292
Marketing category
ANDA
Marketing start
2017-02-15
Marketing end
0000-00-00
Substance
FEBUXOSTAT
Active strength
80 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14445-157-002025-01-30C16284748780-12cef2736-60a0-d83d-e063-dadaa90ab31fThese HIGHLIGHTS do not include all the information needed to use FEBUXOSTAT TABLETS safely and effectively. See full prescribing information for FEBUXOSTAT TABLETS. FEBUXOSTAT tablets, for oral use Initial U.S. Approval: 2009
14445-157-012025-01-30C16284748780-12cef2736-60a0-d83d-e063-dadaa90ab31fThese HIGHLIGHTS do not include all the information needed to use FEBUXOSTAT TABLETS safely and effectively. See full prescribing information for FEBUXOSTAT TABLETS. FEBUXOSTAT tablets, for oral use Initial U.S. Approval: 2009
14445-157-302025-01-30C16284748780-12cef2736-60a0-d83d-e063-dadaa90ab31fThese HIGHLIGHTS do not include all the information needed to use FEBUXOSTAT TABLETS safely and effectively. See full prescribing information for FEBUXOSTAT TABLETS. FEBUXOSTAT tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14445-157-00Febuxostat1000 in 1 BOTTLETABLET, FILM COATED10007
14445-157-01Febuxostat100 in 1 BOTTLETABLET, FILM COATED1007
14445-157-30Febuxostat30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-157FEBUXOSTAT TABLET, FILM COATED [INDOCO REMEDIES LIMITED ]7Legacy NDC, 3 package rows20200113_39ee3ba8-af0d-4273-8c2e-552ba19084a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN39ee3ba8-af0d-4273-8c2e-552ba19084a47
834241febuxostat 80 MG Oral TabletPSN39ee3ba8-af0d-4273-8c2e-552ba19084a47
834235febuxostat 40 MG Oral TabletSCD39ee3ba8-af0d-4273-8c2e-552ba19084a47
834241febuxostat 80 MG Oral TabletSCD39ee3ba8-af0d-4273-8c2e-552ba19084a47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14445-157-00144450157001000 TABLET, FILM COATED in 1 BOTTLE (14445-157-00) 2017-02-150000-00-00NoNoCurrent
14445-157-0114445015701100 TABLET, FILM COATED in 1 BOTTLE (14445-157-01) 2017-02-150000-00-00NoNoCurrent
14445-157-301444501573030 TABLET, FILM COATED in 1 BOTTLE (14445-157-30) 2017-02-150000-00-00NoNoCurrent