Finasteride

Product NDC
67046-1058
11-digit product format
670461058
Labeler code
67046
Product ID
67046-1058_5087f63a-fe7b-3d8d-e063-6394a90ac8ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA078341
Marketing category
ANDA
Marketing start
2026-04-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Finasteride
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1058-3Finasteride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN5087f6f2-92c0-3feb-e063-6394a90ab17d1
310346finasteride 5 MG Oral TabletSCD5087f6f2-92c0-3feb-e063-6394a90ab17d1
310346FIN5C 5 MG Oral TabletSY5087f6f2-92c0-3feb-e063-6394a90ab17d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1058-36704610580330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1058-3) 2026-04-28NoNoCurrent