FDA.reportPublic FDA data

Finasteride

Product NDC
70518-2287
11-digit product format
705182287
Labeler code
70518
Product ID
70518-2287_4e7db6c8-4f77-0460-e063-6394a90ab759
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207750
Marketing category
ANDA
Marketing start
2019-08-27
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
70518-2287-0Finasteride90 in 1 BOTTLE, PLASTICTABLET, COATED9012
70518-2287-1Finasteride30 in 1 BOTTLE, PLASTICTABLET, COATED3012
70518-2287-2Finasteride30 in 1 BLISTER PACKTABLET, COATED3012
70518-2287-3Finasteride12 in 1 BOTTLE, PLASTICTABLET, COATED1212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2287FINASTERIDE TABLET, COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 4 package rows20240911_90cc0d22-fa5c-4fe4-b0bf-554b715a05ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSN90cc0d22-fa5c-4fe4-b0bf-554b715a05ac12
200172finasteride 1 MG Oral TabletSCD90cc0d22-fa5c-4fe4-b0bf-554b715a05ac12
200172FIN5C 1 MG Oral TabletSY90cc0d22-fa5c-4fe4-b0bf-554b715a05ac12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2287-07051822870090 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-2287-0) 2019-08-270000-00-00NoNoCurrent
70518-2287-17051822870130 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-2287-1) 2022-02-140000-00-00NoNoCurrent
70518-2287-27051822870230 in 1 BLISTER PACKHistorical
70518-2287-37051822870312 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-2287-3) 2026-04-02NoNoHistorical