Finasteride

Product NDC
76420-154
11-digit product format
764200154
Labeler code
76420
Product ID
76420-154_c8288d05-1cf2-2623-e053-2995a90a906f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, 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
76420-154-30Finasteride30 in 1 BOTTLETABLET, FILM COATED301
76420-154-90Finasteride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-154FINASTERIDE TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 2 package rows20210728_bafe8674-b7ee-47b2-94c1-842164ca6fa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNbafe8674-b7ee-47b2-94c1-842164ca6fa11
310346finasteride 5 MG Oral TabletSCDbafe8674-b7ee-47b2-94c1-842164ca6fa11
310346FIN5C 5 MG Oral TabletSYbafe8674-b7ee-47b2-94c1-842164ca6fa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-154-307642001543030 TABLET, FILM COATED in 1 BOTTLE (76420-154-30) 2021-07-280000-00-00NoNoCurrent
76420-154-907642001549090 TABLET, FILM COATED in 1 BOTTLE (76420-154-90) 2021-07-280000-00-00NoNoCurrent