FDA.reportPublic FDA data

Finasteride

Product NDC
50090-1936
11-digit product format
500901936
Labeler code
50090
Product ID
50090-1936_d4ce99cc-f100-45f4-93d1-d0fbf3c5b9b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090061
Marketing category
ANDA
Marketing start
2015-06-13
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
50090-1936-0Finasteride30 in 1 BOTTLETABLET, FILM COATED3016
50090-1936-1Finasteride90 in 1 BOTTLETABLET, FILM COATED9016
50090-1936-2Finasteride100 in 1 BOTTLETABLET, FILM COATED10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1936-0EA - Each50090-19363212b14c-8409-4c7a-81f3-cfd7f0026c2e12023-07-06
50090-1936-1EA - Each50090-1936519feb61-4cf6-4dcd-9488-f6e7b360be4912021-09-07
50090-1936-2EA - Each50090-193696fcee70-0ce5-4c64-a1b8-dce3c157e3a612023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1936FINASTERIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 3 package rows20240827_2d726486-f9ef-49d1-b1ae-6b1c8650fa73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN2d726486-f9ef-49d1-b1ae-6b1c8650fa7316
310346finasteride 5 MG Oral TabletSCD2d726486-f9ef-49d1-b1ae-6b1c8650fa7316
310346FIN5C 5 MG Oral TabletSY2d726486-f9ef-49d1-b1ae-6b1c8650fa7316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1936-05009019360030 TABLET, FILM COATED in 1 BOTTLE (50090-1936-0) 2015-07-200000-00-00NoNoCurrent
50090-1936-15009019360190 TABLET, FILM COATED in 1 BOTTLE (50090-1936-1) 2015-07-200000-00-00NoNoCurrent
50090-1936-250090193602100 TABLET, FILM COATED in 1 BOTTLE (50090-1936-2) 2022-02-250000-00-00NoNoCurrent