FDA.reportPublic FDA data

Finasteride

Product NDC
68071-3234
11-digit product format
680713234
Labeler code
68071
Product ID
68071-3234_2d53fd2d-b54d-3fb5-e063-6294a90ab6bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-3234-92025-02-04C16284748780-19d75b9d0-94fc-f424-e053-dadaa90a57ceThese 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
68071-3234-92025-01-30C16284748780-19d75b9d0-94fc-f424-e053-dadaa90a57ceThese 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
68071-3234-92020-05-08C16284748780-19d75b9d0-94fc-f424-e053-dadaa90a57ceThese 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
68071-3234-92020-01-31C16284748780-19d75b9d0-94fc-f424-e053-dadaa90a57ceThese 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
68071-3234-9Finasteride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3234FINASTERIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 1 package rows20250206_6360d8cc-72df-c571-e053-2991aa0a72c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN6360d8cc-72df-c571-e053-2991aa0a72c56
310346finasteride 5 MG Oral TabletSCD6360d8cc-72df-c571-e053-2991aa0a72c56
310346FIN5C 5 MG Oral TabletSY6360d8cc-72df-c571-e053-2991aa0a72c56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-3234-96807132340990 TABLET, FILM COATED in 1 BOTTLE (68071-3234-9) 2018-01-220000-00-00NoNoCurrent