FDA.reportPublic FDA data

Finasteride

Product NDC
71335-1634
11-digit product format
713351634
Labeler code
71335
Product ID
71335-1634_763e08a3-1c25-4229-93c8-3cac476a66a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1634-1Finasteride100 in 1 BOTTLETABLET, FILM COATED1003
71335-1634-2Finasteride30 in 1 BOTTLETABLET, FILM COATED303
71335-1634-3Finasteride60 in 1 BOTTLETABLET, FILM COATED603
71335-1634-4Finasteride90 in 1 BOTTLETABLET, FILM COATED903
71335-1634-5Finasteride500 in 1 BOTTLETABLET, FILM COATED5003
71335-1634-6Finasteride180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1634FINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 6 package rows20200919_88511bd5-624e-49d6-b80e-1f1d47314fb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN88511bd5-624e-49d6-b80e-1f1d47314fb63
310346finasteride 5 MG Oral TabletSCD88511bd5-624e-49d6-b80e-1f1d47314fb63
310346FIN5C 5 MG Oral TabletSY88511bd5-624e-49d6-b80e-1f1d47314fb63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1634-171335163401100 TABLET, FILM COATED in 1 BOTTLE (71335-1634-1) 2020-06-100000-00-00NoNoCurrent
71335-1634-27133516340230 TABLET, FILM COATED in 1 BOTTLE (71335-1634-2) 2020-06-100000-00-00NoNoCurrent
71335-1634-37133516340360 TABLET, FILM COATED in 1 BOTTLE (71335-1634-3) 2020-06-100000-00-00NoNoCurrent
71335-1634-47133516340490 TABLET, FILM COATED in 1 BOTTLE (71335-1634-4) 2020-06-100000-00-00NoNoCurrent
71335-1634-571335163405500 TABLET, FILM COATED in 1 BOTTLE (71335-1634-5) 2020-06-100000-00-00NoNoCurrent
71335-1634-671335163406180 TABLET, FILM COATED in 1 BOTTLE (71335-1634-6) 2020-06-100000-00-00NoNoCurrent