FDA.reportPublic FDA data

Finasteride

Product NDC
50090-6940
11-digit product format
500906940
Labeler code
50090
Product ID
50090-6940_43288fb7-d4bd-46ae-8569-c12efbd47987
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078341
Marketing category
ANDA
Marketing start
2007-10-30
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
50090-6940-0Finasteride30 in 1 BOTTLETABLET, FILM COATED304
50090-6940-1Finasteride90 in 1 BOTTLETABLET, FILM COATED904
50090-6940-2Finasteride100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6940-0EA - Each50090-6940c45c1d13-b77f-4859-aef5-634c880b8eb112024-02-14
50090-6940-1EA - Each50090-694011770d2f-c685-4ed7-8240-63c8bade314712024-02-14
50090-6940-2EA - Each50090-69408e5605a1-74e4-49d4-84bf-090611c0b4a912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6940FINASTERIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Current NDC, 3 package rows20240102_7806f5d3-504a-4b6e-b566-22181f076d3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN7806f5d3-504a-4b6e-b566-22181f076d3f4
310346finasteride 5 MG Oral TabletSCD7806f5d3-504a-4b6e-b566-22181f076d3f4
310346FIN5C 5 MG Oral TabletSY7806f5d3-504a-4b6e-b566-22181f076d3f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6940-05009069400030 TABLET, FILM COATED in 1 BOTTLE (50090-6940-0) 2023-12-15NoNoCurrent
50090-6940-15009069400190 TABLET, FILM COATED in 1 BOTTLE (50090-6940-1) 2023-12-15NoNoCurrent
50090-6940-250090694002100 TABLET, FILM COATED in 1 BOTTLE (50090-6940-2) 2023-12-15NoNoCurrent