FDA.reportPublic FDA data

Finasteride

Product NDC
17856-0090
11-digit product format
178560090
Labeler code
17856
Product ID
17856-0090_385463d5-f3d9-96c0-e063-6294a90ac25e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA090121
Marketing category
ANDA
Marketing start
2010-05-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Finasteride
Listing expiration
2026-12-31

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
17856-0090-12025-04-02C16284748780-1f386c64a-238f-0266-e053-dadaa90a7c1aFinasteride Tablets USP, 5 mg These highlights do not include all the information needed to use finasteride safely and effectively. See full prescribing information for finasteride. Finasteride Tablets USP, 5 mg, for oral use Initial U.S. Approval: 1992
17856-0090-12023-01-30C16284748780-1f386c64a-238f-0266-e053-dadaa90a7c1aFinasteride Tablets USP, 5 mg These highlights do not include all the information needed to use finasteride safely and effectively. See full prescribing information for finasteride. Finasteride Tablets USP, 5 mg, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0090-1Finasteride1 in 1 POUCHTABLET, FILM COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0090FINASTERIDE TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORPS]5Current NDC, Legacy NDC, 1 package rows20250406_29e59387-120c-4367-9f87-75cb53b6460d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN29e59387-120c-4367-9f87-75cb53b6460d6
310346finasteride 5 MG Oral TabletSCD29e59387-120c-4367-9f87-75cb53b6460d6
310346FIN5C 5 MG Oral TabletSY29e59387-120c-4367-9f87-75cb53b6460d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0090-1178560090011 TABLET, FILM COATED in 1 POUCH (17856-0090-1) 2021-01-110000-00-00NoNoCurrent