FDA.reportPublic FDA data

Finasteride

Product NDC
50268-314
11-digit product format
502680314
Labeler code
50268
Product ID
50268-314_47e3617a-bbfd-d911-e063-6294a90ace48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA090061
Marketing category
ANDA
Marketing start
2019-01-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Finasteride
Listing expiration
2027-12-31

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
50268-314-11Finasteride1 in 1 BLISTER PACKTABLET, FILM COATED15
50268-314-15Finasteride50 in 1 BOXTABLET, FILM COATED505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-314-11EA - Each50268-31439edc48a-9a54-4ba6-bc55-e681a9cdea1d12019-04-11
50268-314-15EA - Each50268-314f35f41cb-108d-4d1c-8c61-42821e74520612019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-314FINASTERIDE TABLET, FILM COATED [AVPAK]4Current NDC, Legacy NDC, 2 package rows20220517_800fa54c-c008-ba1e-e053-2a91aa0a2b07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN800fa54c-c008-ba1e-e053-2a91aa0a2b075
310346finasteride 5 MG Oral TabletSCD800fa54c-c008-ba1e-e053-2a91aa0a2b075
310346FIN5C 5 MG Oral TabletSY800fa54c-c008-ba1e-e053-2a91aa0a2b075

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-314-11502680314111 in 1 BLISTER PACKHistorical
50268-314-155026803141550 BLISTER PACK in 1 BOX (50268-314-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-314-11) 50 blister pack2019-01-230000-00-00NoNoCurrent