Finasteride

Product NDC
68788-8377
11-digit product format
687888377
Labeler code
68788
Product ID
68788-8377_eeb61a34-d202-4426-8035-60d0971daf5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA090061
Marketing category
ANDA
Marketing start
2023-02-28
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
68788-8377-1Finasteride100 in 1 BOTTLETABLET, FILM COATED1005
68788-8377-3Finasteride30 in 1 BOTTLETABLET, FILM COATED305
68788-8377-6Finasteride60 in 1 BOTTLETABLET, FILM COATED605
68788-8377-9Finasteride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8377-1EA - Each68788-83774141ca26-a71a-4233-bd2f-7b5cbd461c9a12023-06-06
68788-8377-3EA - Each68788-837726aeeb56-97c5-41b2-9277-cf970b94f77e12023-06-06
68788-8377-6EA - Each68788-83777dadd522-947f-4ac5-8973-2b9641d4b32d12023-06-06
68788-8377-9EA - Each68788-83777cf8fe5d-3e8d-4191-be88-425bdd98c1fc12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8377FINASTERIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, 4 package rows20250514_9ae38bf5-17d7-4af1-922f-b3edb1e65392.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN9ae38bf5-17d7-4af1-922f-b3edb1e653925
310346finasteride 5 MG Oral TabletSCD9ae38bf5-17d7-4af1-922f-b3edb1e653925
310346FIN5C 5 MG Oral TabletSY9ae38bf5-17d7-4af1-922f-b3edb1e653925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8377-168788837701100 TABLET, FILM COATED in 1 BOTTLE (68788-8377-1) 2023-02-28NoNoHistorical
68788-8377-36878883770330 TABLET, FILM COATED in 1 BOTTLE (68788-8377-3) 2023-02-28NoNoHistorical
68788-8377-66878883770660 TABLET, FILM COATED in 1 BOTTLE (68788-8377-6) 2023-02-28NoNoHistorical
68788-8377-96878883770990 TABLET, FILM COATED in 1 BOTTLE (68788-8377-9) 2023-02-28NoNoHistorical