FDA.reportPublic FDA data

Finasteride

Product NDC
68071-3380
11-digit product format
680713380
Labeler code
68071
Product ID
68071-3380_1ce945ae-76ae-0366-e063-6294a90ab575
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090121
Marketing category
ANDA
Marketing start
2010-05-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3380-32024-07-10C16284748780-1ba0f9c33-1ee6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets 5 mg, for oral use Initial U.S. Approval: 1992
68071-3380-32023-01-30C16284748780-1ba0f9c33-1ee6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets 5 mg, for oral use Initial U.S. Approval: 1992
68071-3380-32021-02-12C16284748780-1ba0f9c33-1ee6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets 5 mg, for oral use Initial U.S. Approval: 1992
68071-3380-32021-01-29C16284748780-1ba0f9c33-1ee6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets 5 mg, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3380-3Finasteride30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3380FINASTERIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240711_549aab5d-819a-1691-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN549aab5d-819a-1691-e054-00144ff88e884
310346finasteride 5 MG Oral TabletSCD549aab5d-819a-1691-e054-00144ff88e884
310346FIN5C 5 MG Oral TabletSY549aab5d-819a-1691-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-3380-36807133800330 TABLET, FILM COATED in 1 BOTTLE (68071-3380-3) 2017-07-180000-00-00NoNoCurrent