FDA.reportPublic FDA data

Finasteride

Product NDC
50436-0089
11-digit product format
504360089
Labeler code
50436
Product ID
50436-0089_dd9bfbf7-9932-4b36-9607-1f7a2bce6505
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA091643
Marketing category
ANDA
Marketing start
2013-11-08
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
50436-0089-12021-01-29C16284748780-1ba0f9c33-2539-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. FINASTERIDE tablets, for oral use Initial U.S. Approval: 1992
50436-0089-32021-01-29C16284748780-1ba0f9c33-2539-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. FINASTERIDE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0089-1Finasteride30 in 1 BOTTLETABLET, FILM COATED302
50436-0089-3Finasteride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0089FINASTERIDE TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20190222_23376932-2728-4d0b-b8ee-d32966c1eade.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSN23376932-2728-4d0b-b8ee-d32966c1eade2
200172finasteride 1 MG Oral TabletSCD23376932-2728-4d0b-b8ee-d32966c1eade2
200172FIN5C 1 MG Oral TabletSY23376932-2728-4d0b-b8ee-d32966c1eade2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0089-15043600890130 in 1 BOTTLEHistorical
50436-0089-35043600890390 in 1 BOTTLEHistorical