Finasteride

Product NDC
72189-542
11-digit product format
721890542
Labeler code
72189
Product ID
72189-542_4615ec4d-f6e1-70c0-e063-6394a90a154f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA204304
Marketing category
ANDA
Marketing start
2024-03-11
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
72189-542-30Finasteride30 in 1 BOTTLETABLET, FILM COATED302
72189-542-90Finasteride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-542-30EA - Each72189-542eeab1b89-84bf-4fe6-a4d4-4a87f7ed1d7612026-01-08
72189-542-90EA - Each72189-54255a2c5e8-e9d0-46c0-a75d-f3702856fee412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-542FINASTERIDE TABLET, FILM COATED [DIRECT_RX]1Current NDC, 2 package rows20240316_13673a09-8a50-5cd0-e063-6294a90a3d5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN13673a09-8a50-5cd0-e063-6294a90a3d5b2
310346finasteride 5 MG Oral TabletSCD13673a09-8a50-5cd0-e063-6294a90a3d5b2
310346FIN5C 5 MG Oral TabletSY13673a09-8a50-5cd0-e063-6294a90a3d5b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-542-307218905423030 TABLET, FILM COATED in 1 BOTTLE (72189-542-30) 2024-03-11NoNoHistorical
72189-542-907218905429090 TABLET, FILM COATED in 1 BOTTLE (72189-542-90) 2024-03-11NoNoHistorical