FDA.reportPublic FDA data

Finasteride

Product NDC
71335-1898
11-digit product format
713351898
Labeler code
71335
Product ID
71335-1898_51362916-fdb1-4a6c-8fa8-927a2cf43a98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204304
Marketing category
ANDA
Marketing start
2017-01-05
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
71335-1898-1Finasteride100 in 1 BOTTLETABLET, FILM COATED100105
71335-1898-2Finasteride30 in 1 BOTTLETABLET, FILM COATED30105
71335-1898-3Finasteride60 in 1 BOTTLETABLET, FILM COATED60105
71335-1898-4Finasteride90 in 1 BOTTLETABLET, FILM COATED90105
71335-1898-5Finasteride500 in 1 BOTTLETABLET, FILM COATED500105
71335-1898-6Finasteride180 in 1 BOTTLETABLET, FILM COATED180105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1898FINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 6 package rows20240824_a7a3af01-de3f-4cd4-ba05-a41ca0544ac2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNa7a3af01-de3f-4cd4-ba05-a41ca0544ac2105
310346finasteride 5 MG Oral TabletSCDa7a3af01-de3f-4cd4-ba05-a41ca0544ac2105
310346FIN5C 5 MG Oral TabletSYa7a3af01-de3f-4cd4-ba05-a41ca0544ac2105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1898-171335189801100 TABLET, FILM COATED in 1 BOTTLE (71335-1898-1) 2024-05-310000-00-00NoNoCurrent
71335-1898-27133518980230 TABLET, FILM COATED in 1 BOTTLE (71335-1898-2) 2021-10-150000-00-00NoNoCurrent
71335-1898-37133518980360 TABLET, FILM COATED in 1 BOTTLE (71335-1898-3) 2021-11-090000-00-00NoNoCurrent
71335-1898-47133518980490 TABLET, FILM COATED in 1 BOTTLE (71335-1898-4) 2021-06-210000-00-00NoNoCurrent
71335-1898-571335189805500 TABLET, FILM COATED in 1 BOTTLE (71335-1898-5) 2024-05-310000-00-00NoNoCurrent
71335-1898-671335189806180 TABLET, FILM COATED in 1 BOTTLE (71335-1898-6) 2024-05-310000-00-00NoNoCurrent