FDA.reportPublic FDA data

Finasteride

Product NDC
68071-4167
11-digit product format
680714167
Labeler code
68071
Product ID
68071-4167_c365f95f-b977-b751-e053-2995a90af597
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
2022-12-31
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
68071-4167-32023-01-30C16284748780-1ba0f9c33-2da5-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
68071-4167-32021-02-15C16284748780-1ba0f9c33-2da5-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
68071-4167-32021-01-29C16284748780-1ba0f9c33-2da5-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
68071-4167-3Finasteride30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4167FINASTERIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC, 1 package rows20210529_5f26924c-8b02-0baa-e053-2991aa0acce0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSN5f26924c-8b02-0baa-e053-2991aa0acce04
200172finasteride 1 MG Oral TabletSCD5f26924c-8b02-0baa-e053-2991aa0acce04
200172FIN5C 1 MG Oral TabletSY5f26924c-8b02-0baa-e053-2991aa0acce04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4167-36807141670330 TABLET, FILM COATED in 1 BOTTLE (68071-4167-3) 2017-11-290000-00-00NoNoCurrent