FDA.reportPublic FDA data

Finasteride

Product NDC
68071-3094
11-digit product format
680713094
Labeler code
68071
Product ID
68071-3094_1d9cdc2c-3f76-5cd4-e063-6294a90a1bcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090060
Marketing category
ANDA
Marketing start
2013-07-01
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
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
FINASTERIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57GNO57U7G
Rxcui200172

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
68071-3094-32024-07-19C16284748780-1ba0f9c33-27df-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. Finasteride Tablets USP for oral use Initial U.S. Approval: 1992
68071-3094-32023-01-30C16284748780-1ba0f9c33-27df-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. Finasteride Tablets USP for oral use Initial U.S. Approval: 1992
68071-3094-32021-02-11C16284748780-1ba0f9c33-27df-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. Finasteride Tablets USP for oral use Initial U.S. Approval: 1992
68071-3094-32021-01-29C16284748780-1ba0f9c33-27df-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. Finasteride Tablets USP for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3094-3Finasteride30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3094FINASTERIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240720_8f2626ef-66d9-6a77-e053-2995a90af056.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSN8f2626ef-66d9-6a77-e053-2995a90af0563
200172finasteride 1 MG Oral TabletSCD8f2626ef-66d9-6a77-e053-2995a90af0563
200172FIN5C 1 MG Oral TabletSY8f2626ef-66d9-6a77-e053-2995a90af0563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-3094-36807130940330 TABLET, FILM COATED in 1 BOTTLE (68071-3094-3) 2019-08-020000-00-00NoNoCurrent