FDA.reportPublic FDA data

Finasteride

Product NDC
71335-1530
11-digit product format
713351530
Labeler code
71335
Product ID
71335-1530_7b1f267c-70e7-4d31-8389-c4a59ccd727b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078341
Marketing category
ANDA
Marketing start
2007-10-30
Substance
FINASTERIDE
Active strength
5 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase 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
Finasteride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FINASTERIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57GNO57U7G
Rxcui310346

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
71335-1530-12024-05-20C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-22024-05-20C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-32024-05-20C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-42024-05-20C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-52024-05-20C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-62024-05-20C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-12024-01-30C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-22024-01-30C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-32024-01-30C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-42024-01-30C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-52024-01-30C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-62024-01-30C16284748780-11030e365-3455-111a-e063-dadaa90a10e2These 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
71335-1530-1Finasteride100 in 1 BOTTLETABLET, FILM COATED1003
71335-1530-2Finasteride30 in 1 BOTTLETABLET, FILM COATED303
71335-1530-3Finasteride60 in 1 BOTTLETABLET, FILM COATED603
71335-1530-4Finasteride90 in 1 BOTTLETABLET, FILM COATED903
71335-1530-5Finasteride500 in 1 BOTTLETABLET, FILM COATED5003
71335-1530-6Finasteride180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1530FINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 6 package rows20240522_61e6cbb8-ddd2-4e07-b182-6348f216858b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN61e6cbb8-ddd2-4e07-b182-6348f216858b3
310346finasteride 5 MG Oral TabletSCD61e6cbb8-ddd2-4e07-b182-6348f216858b3
310346FIN5C 5 MG Oral TabletSY61e6cbb8-ddd2-4e07-b182-6348f216858b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1530-171335153001100 TABLET, FILM COATED in 1 BOTTLE (71335-1530-1) 2021-12-280000-00-00NoNoCurrent
71335-1530-27133515300230 TABLET, FILM COATED in 1 BOTTLE (71335-1530-2) 2020-03-060000-00-00NoNoCurrent
71335-1530-37133515300360 TABLET, FILM COATED in 1 BOTTLE (71335-1530-3) 2021-12-280000-00-00NoNoCurrent
71335-1530-47133515300490 TABLET, FILM COATED in 1 BOTTLE (71335-1530-4) 2020-03-200000-00-00NoNoCurrent
71335-1530-571335153005500 TABLET, FILM COATED in 1 BOTTLE (71335-1530-5) 2021-12-280000-00-00NoNoCurrent
71335-1530-671335153006180 TABLET, FILM COATED in 1 BOTTLE (71335-1530-6) 2021-12-280000-00-00NoNoCurrent