FDA.reportPublic FDA data

Finasteride

Product NDC
76282-412
11-digit product format
762820412
Labeler code
76282
Product ID
76282-412_6e0d44f6-d0c0-4db5-b0ea-8f52dd2e5613
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA090061
Marketing category
ANDA
Marketing start
2015-05-22
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
76282-412-05Finasteride500 in 1 BOTTLETABLET, FILM COATED5006
76282-412-10Finasteride1000 in 1 BOTTLETABLET, FILM COATED10006
76282-412-30Finasteride30 in 1 BOTTLETABLET, FILM COATED306
76282-412-90Finasteride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-412-05EA - Each76282-412a32c976e-d916-4a2c-bd20-8a386ac31a7512013-11-04
76282-412-30EA - Each76282-412d261e7f3-76ca-433e-87be-efb19022fb5112013-11-04
76282-412-90EA - Each76282-41262d5a9de-3f55-4419-8f6e-2ede91543e6612013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-412FINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 4 package rows20201104_1c1bf77c-f99a-44e4-b71e-ce766afa99b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN1c1bf77c-f99a-44e4-b71e-ce766afa99b66
310346finasteride 5 MG Oral TabletSCD1c1bf77c-f99a-44e4-b71e-ce766afa99b66
310346FIN5C 5 MG Oral TabletSY1c1bf77c-f99a-44e4-b71e-ce766afa99b66
310346finasteride 5 MG Oral TabletPSN57e73fff-2115-41ad-864b-4652f9fd45452
310346finasteride 5 MG Oral TabletSCD57e73fff-2115-41ad-864b-4652f9fd45452
310346FIN5C 5 MG Oral TabletSY57e73fff-2115-41ad-864b-4652f9fd45452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-412-0576282041205500 TABLET, FILM COATED in 1 BOTTLE (76282-412-05) 2015-05-220000-00-00NoNoCurrent
76282-412-10762820412101000 TABLET, FILM COATED in 1 BOTTLE (76282-412-10) 2015-05-220000-00-00NoNoCurrent
76282-412-307628204123030 TABLET, FILM COATED in 1 BOTTLE (76282-412-30) 2015-05-220000-00-00NoNoCurrent
76282-412-907628204129090 TABLET, FILM COATED in 1 BOTTLE (76282-412-90) 2015-05-220000-00-00NoNoCurrent