FDA.reportPublic FDA data

Finasteride

Product NDC
71713-096
11-digit product format
717130096
Labeler code
71713
Product ID
71713-096_ecdd4925-db44-f8de-e053-2995a90a83ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Thirty Madison Inc
Application
ANDA091643
Marketing category
ANDA
Marketing start
2019-06-12
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
71713-096-902025-01-30C16284748780-12cef2736-59ba-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71713-096-90Finasteride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71713-096-90EA - Each71713-0964ad6e2ac-bd64-4e82-8f17-146c99bb101e12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71713-096FINASTERIDE TABLET, FILM COATED [THIRTY MADISON INC]2Legacy NDC, 1 package rows20221108_df82de18-6113-4644-a54d-b57b646956c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSNdf82de18-6113-4644-a54d-b57b646956c62
200172finasteride 1 MG Oral TabletSCDdf82de18-6113-4644-a54d-b57b646956c62
200172FIN5C 1 MG Oral TabletSYdf82de18-6113-4644-a54d-b57b646956c62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71713-096-907171300969090 TABLET, FILM COATED in 1 BOTTLE (71713-096-90) 2019-06-120000-00-00NoNoCurrent