FDA.reportPublic FDA data

Finasteride

Product NDC
70518-3600
11-digit product format
705183600
Labeler code
70518
Product ID
70518-3600_4f5cb9eb-b2a4-db0d-e063-6294a90af371
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204304
Marketing category
ANDA
Marketing start
2022-12-28
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
70518-3600-0Finasteride1 in 1 POUCHTABLET, FILM COATED19
70518-3600-1Finasteride30 in 1 BOXTABLET, FILM COATED309
70518-3600-2Finasteride30 in 1 BLISTER PACKTABLET, FILM COATED309
70518-3600-3Finasteride30 in 1 BLISTER PACKTABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3600FINASTERIDE TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, 4 package rows20241012_aa3fcd1a-02a1-49db-b40e-75e623d730e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNaa3fcd1a-02a1-49db-b40e-75e623d730e19
310346finasteride 5 MG Oral TabletSCDaa3fcd1a-02a1-49db-b40e-75e623d730e19
310346FIN5C 5 MG Oral TabletSYaa3fcd1a-02a1-49db-b40e-75e623d730e19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3600-0705183600001 in 1 POUCHHistorical
70518-3600-17051836000130 POUCH in 1 BOX (70518-3600-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3600-0) 30 pouch2022-12-28NoNoCurrent
70518-3600-27051836000230 in 1 BLISTER PACKHistorical
70518-3600-37051836000330 in 1 BLISTER PACKHistorical