FDA.reportPublic FDA data

Finasteride

Product NDC
70518-3616
11-digit product format
705183616
Labeler code
70518
Product ID
70518-3616_4f6b9cfd-9605-6f66-e063-6294a90a13a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078341
Marketing category
ANDA
Marketing start
2023-01-18
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
70518-3616-0Finasteride30 in 1 BLISTER PACKTABLET, FILM COATED3012
70518-3616-1Finasteride30 in 1 BOXTABLET, FILM COATED3012
70518-3616-2Finasteride1 in 1 POUCHTABLET, FILM COATED112
70518-3616-3Finasteride30 in 1 BLISTER PACKTABLET, FILM COATED3012
70518-3616-4Finasteride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9012
70518-3616-5Finasteride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3616FINASTERIDE TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, 6 package rows20241012_e482a50d-db15-4407-85c9-160c88e8a657.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNe482a50d-db15-4407-85c9-160c88e8a65712
310346finasteride 5 MG Oral TabletSCDe482a50d-db15-4407-85c9-160c88e8a65712
310346FIN5C 5 MG Oral TabletSYe482a50d-db15-4407-85c9-160c88e8a65712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3616-07051836160030 in 1 BLISTER PACKHistorical
70518-3616-17051836160130 POUCH in 1 BOX (70518-3616-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3616-2) 30 pouch2023-02-10NoNoCurrent
70518-3616-2705183616021 in 1 POUCHHistorical
70518-3616-37051836160330 TABLET, FILM COATED in 1 BLISTER PACK (70518-3616-3) 2023-05-10NoNoCurrent
70518-3616-47051836160490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3616-4) 2024-01-25NoNoCurrent
70518-3616-570518361605100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3616-5) 2024-08-07NoNoCurrent