FDA.reportPublic FDA data

Finasteride

Product NDC
50436-0927
11-digit product format
504360927
Labeler code
50436
Product ID
50436-0927_72302b6e-7b6a-4ac9-9998-b03eadf39a7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA203687
Marketing category
ANDA
Marketing start
2014-09-20
Marketing end
0000-00-00
Substance
FINASTERIDE
Active strength
1 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
d00474ae-23eb-a8eb-bf56-520e590cc6dbProduct name220170406
0f90664c-9d0e-f046-dc6a-73563cd8347eProduct name220170405

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0927-12021-01-29C16284748780-1ba0f9c33-4233-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use finasteride tablets safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE tablets USP, 1 mg for oral use Initial U.S. Approval: 1992
50436-0927-32021-01-29C16284748780-1ba0f9c33-4233-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use finasteride tablets safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE tablets USP, 1 mg for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0927-1Finasteride30 in 1 BOTTLETABLET, FILM COATED302
50436-0927-3Finasteride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0927FINASTERIDE TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20181207_f477dc5b-1c53-4866-bcba-8e26b2873a2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSNf477dc5b-1c53-4866-bcba-8e26b2873a2b2
200172finasteride 1 MG Oral TabletSCDf477dc5b-1c53-4866-bcba-8e26b2873a2b2
200172FIN5C 1 MG Oral TabletSYf477dc5b-1c53-4866-bcba-8e26b2873a2b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0927-15043609270130 in 1 BOTTLEHistorical
50436-0927-35043609270390 in 1 BOTTLEHistorical