FDA.reportPublic FDA data

Finasteride

Product NDC
63629-1585
11-digit product format
636291585
Labeler code
63629
Product ID
63629-1585_07ca7b87-0393-4f2d-bddc-143751084103
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
63629-1585-1Finasteride100 in 1 BOTTLETABLET, FILM COATED10010
63629-1585-2Finasteride30 in 1 BOTTLETABLET, FILM COATED3010
63629-1585-3Finasteride60 in 1 BOTTLETABLET, FILM COATED6010
63629-1585-4Finasteride90 in 1 BOTTLETABLET, FILM COATED9010
63629-1585-5Finasteride500 in 1 BOTTLETABLET, FILM COATED50010
63629-1585-6Finasteride180 in 1 BOTTLETABLET, FILM COATED18010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1585-1EA - Each63629-1585297c2994-290c-4a7f-9d9e-98d76f0d4c0312012-07-24
63629-1585-2EA - Each63629-1585e8037b78-6533-49c7-bd20-0a0d17c09ed812012-07-24
63629-1585-3EA - Each63629-15850fd5431a-f201-48e9-958c-8deacdd01a3312012-07-24
63629-1585-4EA - Each63629-15857c33f17a-5288-4454-878a-c8c84a2b493412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNc9a3cb34-9a8e-4538-ab90-32e08d8acc3a10
310346finasteride 5 MG Oral TabletSCDc9a3cb34-9a8e-4538-ab90-32e08d8acc3a10
310346FIN5C 5 MG Oral TabletSYc9a3cb34-9a8e-4538-ab90-32e08d8acc3a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-1585-163629158501100 TABLET, FILM COATED in 1 BOTTLE (63629-1585-1) 2026-05-08NoNoHistorical
63629-1585-26362915850230 TABLET, FILM COATED in 1 BOTTLE (63629-1585-2) 2026-05-08NoNoHistorical
63629-1585-36362915850360 TABLET, FILM COATED in 1 BOTTLE (63629-1585-3) 2026-05-08NoNoHistorical
63629-1585-46362915850490 TABLET, FILM COATED in 1 BOTTLE (63629-1585-4) 2026-05-08NoNoHistorical
63629-1585-563629158505500 TABLET, FILM COATED in 1 BOTTLE (63629-1585-5) 2026-05-08NoNoHistorical
63629-1585-663629158506180 TABLET, FILM COATED in 1 BOTTLE (63629-1585-6) 2026-05-08NoNoHistorical