FDA.reportPublic FDA data

Finasteride

Product NDC
68788-8275
11-digit product format
687888275
Labeler code
68788
Product ID
68788-8275_a4242cc3-63e0-4514-8594-e69887285baa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207750
Marketing category
ANDA
Marketing start
2022-10-14
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8275-3Finasteride30 in 1 BOTTLETABLET, COATED304
68788-8275-6Finasteride60 in 1 BOTTLETABLET, COATED604
68788-8275-9Finasteride90 in 1 BOTTLETABLET, COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8275-3EA - Each68788-8275d928b4a4-9b81-4684-b8a9-893ca921d19c12022-11-07
68788-8275-6EA - Each68788-82756814b956-f782-48c2-8319-b3772d53f81212022-11-07
68788-8275-9EA - Each68788-82750a5f8ce2-e1ed-4bee-870c-f25b8cc6a32812022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8275FINASTERIDE TABLET, COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240426_b84a67d6-695e-4a7c-9b60-95e9ad18a501.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSNb84a67d6-695e-4a7c-9b60-95e9ad18a5014
200172finasteride 1 MG Oral TabletSCDb84a67d6-695e-4a7c-9b60-95e9ad18a5014
200172FIN5C 1 MG Oral TabletSYb84a67d6-695e-4a7c-9b60-95e9ad18a5014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8275-36878882750330 TABLET, COATED in 1 BOTTLE (68788-8275-3) 2022-10-140000-00-00NoNoCurrent
68788-8275-66878882750660 TABLET, COATED in 1 BOTTLE (68788-8275-6) 2022-10-140000-00-00NoNoCurrent
68788-8275-96878882750990 TABLET, COATED in 1 BOTTLE (68788-8275-9) 2022-10-140000-00-00NoNoCurrent