FDA.reportPublic FDA data

Finasteride

Product NDC
50090-4697
11-digit product format
500904697
Labeler code
50090
Product ID
50090-4697_2bae8977-9b78-48c9-a22a-9ea0c4c5075c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4697-02023-02-07C16284748780-1f386c649-b005-0266-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
50090-4697-12023-02-07C16284748780-1f386c649-b005-0266-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
50090-4697-22023-02-07C16284748780-1f386c649-b005-0266-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
50090-4697-02023-01-30C16284748780-1f386c649-b005-0266-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
50090-4697-12023-01-30C16284748780-1f386c649-b005-0266-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
50090-4697-22023-01-30C16284748780-1f386c649-b005-0266-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
50090-4697-0Finasteride30 in 1 BOTTLETABLET, FILM COATED308
50090-4697-1Finasteride90 in 1 BOTTLETABLET, FILM COATED908
50090-4697-2Finasteride100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4697FINASTERIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 3 package rows20230811_5e69ea84-dc5a-4aac-9353-4920c6f7b3aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN5e69ea84-dc5a-4aac-9353-4920c6f7b3aa8
310346finasteride 5 MG Oral TabletSCD5e69ea84-dc5a-4aac-9353-4920c6f7b3aa8
310346FIN5C 5 MG Oral TabletSY5e69ea84-dc5a-4aac-9353-4920c6f7b3aa8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4697-05009046970030 TABLET, FILM COATED in 1 BOTTLE (50090-4697-0) 2019-11-070000-00-00NoNoCurrent
50090-4697-15009046970190 TABLET, FILM COATED in 1 BOTTLE (50090-4697-1) 2019-11-070000-00-00NoNoCurrent
50090-4697-250090469702100 TABLET, FILM COATED in 1 BOTTLE (50090-4697-2) 2019-11-070000-00-00NoNoCurrent