FDA.reportPublic FDA data

Finasteride

Product NDC
33261-833
11-digit product format
332610833
Labeler code
33261
Product ID
33261-833_7cc09057-0a72-4ba6-9541-b8b5501d885f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA090061
Marketing category
ANDA
Marketing start
2012-10-25
Marketing end
0000-00-00
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
2019-12-31
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
33261-833-902020-01-31C16284748780-19d75b9d0-a297-f424-e053-dadaa90a57ceThese 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 Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-833-90Finasteride90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-833-90EA - Each33261-8334d1dd216-addd-4b4c-a542-811c8bbf7e1d12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-833FINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140107_d089b70b-7961-488a-8f65-83038e169983.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNd089b70b-7961-488a-8f65-83038e1699831
310346finasteride 5 MG Oral TabletSCDd089b70b-7961-488a-8f65-83038e1699831
310346FIN5C 5 MG Oral TabletSYd089b70b-7961-488a-8f65-83038e1699831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-833-903326108339090 in 1 BOTTLE, PLASTICHistorical