FDA.reportPublic FDA data

Finasteride

Product NDC
71610-515
11-digit product format
716100515
Labeler code
71610
Product ID
71610-515_15466f40-4ce1-71aa-e063-6294a90a3f19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
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
71610-515-30Finasteride30 in 1 BOTTLETABLET, FILM COATED302
71610-515-53Finasteride60 in 1 BOTTLETABLET, FILM COATED602
71610-515-60Finasteride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-515-30EA - Each71610-515faccacdc-4e0f-40a3-8e9f-441af847344f12024-05-16
71610-515-53EA - Each71610-5152e18909a-8875-40c2-b55e-81e3443fa8c812024-05-16
71610-515-60EA - Each71610-515195eaada-7462-4bbc-84fc-43977776587412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-515FINASTERIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 3 package rows20240410_57e73fff-2115-41ad-864b-4652f9fd4545.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71610-515-307161005153030 TABLET, FILM COATED in 1 BOTTLE (71610-515-30) 2024-04-03NoNoCurrent
71610-515-537161005155360 TABLET, FILM COATED in 1 BOTTLE (71610-515-53) 2024-04-03NoNoCurrent
71610-515-607161005156090 TABLET, FILM COATED in 1 BOTTLE (71610-515-60) 2021-01-080000-00-00NoNoCurrent