Finasteride

Product NDC
55154-8083
11-digit product format
551548083
Labeler code
55154
Product ID
55154-8083_34aa24ef-7025-4347-97e6-c2eec30dfad8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090061
Marketing category
ANDA
Marketing start
2015-06-13
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
55154-8083-0Finasteride10 in 1 BAGTABLET, FILM COATED108
55154-8083-0Finasteride1 in 1 BLISTER PACKTABLET, FILM COATED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8083FINASTERIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]5Current NDC, Legacy NDC, 2 package rows20240228_3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd048
310346finasteride 5 MG Oral TabletSCD3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd048
310346FIN5C 5 MG Oral TabletSY3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd048

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8083-05515480830010 BLISTER PACK in 1 BAG (55154-8083-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2015-06-130000-00-00NoNoCurrent