Finasteride

Product NDC
68788-8433
11-digit product format
687888433
Labeler code
68788
Product ID
68788-8433_5d4b1d8d-6e91-42aa-bc00-454a8cf4d30a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204304
Marketing category
ANDA
Marketing start
2024-04-24
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
68788-8433-1Finasteride100 in 1 BOTTLETABLET, FILM COATED1002
68788-8433-3Finasteride30 in 1 BOTTLETABLET, FILM COATED302
68788-8433-6Finasteride60 in 1 BOTTLETABLET, FILM COATED602
68788-8433-9Finasteride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8433-1EA - Each68788-84334e191c50-250b-46ba-9b90-fabf884cedc712024-05-16
68788-8433-3EA - Each68788-8433dab09c12-e1a7-450a-a625-9387628cd87212024-05-16
68788-8433-6EA - Each68788-8433f800eebb-699d-44fd-baab-3d892264fb4612024-05-16
68788-8433-9EA - Each68788-84333df80798-eada-4d1d-8732-861f889f4e9912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8433FINASTERIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20250514_33295dce-1e81-4187-bce1-d9b332ea062e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN33295dce-1e81-4187-bce1-d9b332ea062e2
310346finasteride 5 MG Oral TabletSCD33295dce-1e81-4187-bce1-d9b332ea062e2
310346FIN5C 5 MG Oral TabletSY33295dce-1e81-4187-bce1-d9b332ea062e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8433-168788843301100 TABLET, FILM COATED in 1 BOTTLE (68788-8433-1) 2024-04-24NoNoHistorical
68788-8433-36878884330330 TABLET, FILM COATED in 1 BOTTLE (68788-8433-3) 2024-04-24NoNoHistorical
68788-8433-66878884330660 TABLET, FILM COATED in 1 BOTTLE (68788-8433-6) 2024-04-24NoNoHistorical
68788-8433-96878884330990 TABLET, FILM COATED in 1 BOTTLE (68788-8433-9) 2024-04-24NoNoHistorical