FDA.reportPublic FDA data

Finasteride

Product NDC
50090-4648
11-digit product format
500904648
Labeler code
50090
Product ID
50090-4648_addc5510-c03f-49ba-89a5-d1419a4b1203
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4648-02023-02-06C16284748780-1f386c649-fc86-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use Initial U.S. Approval: 1992
50090-4648-02023-01-30C16284748780-1f386c649-fc86-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4648-0Finasteride90 in 1 BOTTLETABLET, COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4648-0EA - Each50090-464892835803-ca37-4486-bc81-595ec55865c112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4648FINASTERIDE TABLET, COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 1 package rows20250123_49eb3a1e-d7e6-4652-aa6d-6abf21af34a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSN49eb3a1e-d7e6-4652-aa6d-6abf21af34a610
200172finasteride 1 MG Oral TabletSCD49eb3a1e-d7e6-4652-aa6d-6abf21af34a610
200172FIN5C 1 MG Oral TabletSY49eb3a1e-d7e6-4652-aa6d-6abf21af34a610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4648-05009046480090 TABLET, COATED in 1 BOTTLE (50090-4648-0) 2019-10-240000-00-00NoNoCurrent