FDA.reportPublic FDA data

Finasteride

Product NDC
70518-3182
11-digit product format
705183182
Labeler code
70518
Product ID
70518-3182_4f565ec4-d6ed-7223-e063-6294a90a8c2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090061
Marketing category
ANDA
Marketing start
2021-08-05
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3182-02023-03-20C16284748780-1f386c649-fccd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992
70518-3182-02023-01-30C16284748780-1f386c649-fccd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3182-0Finasteride30 in 1 BOXTABLET, FILM COATED308
70518-3182-1Finasteride1 in 1 POUCHTABLET, FILM COATED18
70518-3182-2Finasteride30 in 1 BOXTABLET, FILM COATED308
70518-3182-3Finasteride1 in 1 POUCHTABLET, FILM COATED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3182FINASTERIDE TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 4 package rows20241013_c2875bc7-e811-4860-9131-da06cecc2137.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNc2875bc7-e811-4860-9131-da06cecc21378
310346finasteride 5 MG Oral TabletSCDc2875bc7-e811-4860-9131-da06cecc21378
310346FIN5C 5 MG Oral TabletSYc2875bc7-e811-4860-9131-da06cecc21378

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3182-07051831820030 POUCH in 1 BOX (70518-3182-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3182-1) 30 pouch2021-08-050000-00-00NoNoCurrent
70518-3182-1705183182011 in 1 POUCHHistorical
70518-3182-27051831820230 in 1 BOXHistorical
70518-3182-3705183182031 in 1 POUCHHistorical