Finasteride

Product NDC
68071-3785
11-digit product format
680713785
Labeler code
68071
Product ID
68071-3785_40bd923b-50f8-c9dd-e063-6294a90a71f3
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3785-2Finasteride120 in 1 BOTTLETABLET, FILM COATED1203
68071-3785-6Finasteride60 in 1 BOTTLETABLET, FILM COATED603
68071-3785-8Finasteride180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3785FINASTERIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 3 package rows20250125_2c688ec5-1b0f-2269-e063-6394a90a7220.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN2c688ec5-1b0f-2269-e063-6394a90a72203
310346finasteride 5 MG Oral TabletSCD2c688ec5-1b0f-2269-e063-6394a90a72203
310346FIN5C 5 MG Oral TabletSY2c688ec5-1b0f-2269-e063-6394a90a72203

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3785-268071378502120 TABLET, FILM COATED in 1 BOTTLE (68071-3785-2) 2025-01-23NoNoCurrent
68071-3785-66807137850660 TABLET, FILM COATED in 1 BOTTLE (68071-3785-6) 2025-10-09NoNoCurrent
68071-3785-868071378508180 TABLET, FILM COATED in 1 BOTTLE (68071-3785-8) 2025-01-23NoNoCurrent