FDA.reportPublic FDA data

Finasteride

Product NDC
71205-790
11-digit product format
712050790
Labeler code
71205
Product ID
71205-790_196f7d23-ed90-46c2-ae34-615e6ec1650b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207750
Marketing category
ANDA
Marketing start
2017-01-06
Substance
FINASTERIDE
Active strength
1 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
FINASTERIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57GNO57U7G
Rxcui200172

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
71205-790-30Finasteride30 in 1 BOTTLETABLET, COATED301
71205-790-60Finasteride60 in 1 BOTTLETABLET, COATED601
71205-790-90Finasteride90 in 1 BOTTLETABLET, COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-790FINASTERIDE TABLET, COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230420_196f7d23-ed90-46c2-ae34-615e6ec1650b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSN196f7d23-ed90-46c2-ae34-615e6ec1650b1
200172finasteride 1 MG Oral TabletSCD196f7d23-ed90-46c2-ae34-615e6ec1650b1
200172FIN5C 1 MG Oral TabletSY196f7d23-ed90-46c2-ae34-615e6ec1650b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-790-307120507903030 TABLET, COATED in 1 BOTTLE (71205-790-30) 2023-04-17NoNoCurrent
71205-790-607120507906060 TABLET, COATED in 1 BOTTLE (71205-790-60) 2023-04-17NoNoCurrent
71205-790-907120507909090 TABLET, COATED in 1 BOTTLE (71205-790-90) 2023-04-17NoNoCurrent