FDA.reportPublic FDA data

Finasteride

Product NDC
71610-520
11-digit product format
716100520
Labeler code
71610
Product ID
71610-520_ab63782b-6982-4cd8-a80f-e8f3da372177
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
71610-520-30Finasteride30 in 1 BOTTLETABLET, FILM COATED302
71610-520-60Finasteride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-520-30EA - Each71610-520078cb8d5-c7a9-4cba-9b24-3708b2153acd12022-04-06
71610-520-60EA - Each71610-520847e6bce-bdc4-4288-99f7-28a62e67eaa112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-520FINASTERIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20220304_845cad9c-c50d-4c98-8df8-893d1241836a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN845cad9c-c50d-4c98-8df8-893d1241836a2
310346finasteride 5 MG Oral TabletSCD845cad9c-c50d-4c98-8df8-893d1241836a2
310346FIN5C 5 MG Oral TabletSY845cad9c-c50d-4c98-8df8-893d1241836a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-520-307161005203030 TABLET, FILM COATED in 1 BOTTLE (71610-520-30) 2022-02-220000-00-00NoNoCurrent
71610-520-607161005206090 TABLET, FILM COATED in 1 BOTTLE (71610-520-60) 2021-01-270000-00-00NoNoCurrent