FDA.reportPublic FDA data

Finasteride

Product NDC
65977-5025
11-digit product format
659775025
Labeler code
65977
Product ID
65977-5025_61788ac8-2837-4419-942d-cb47143c95f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET
Route
ORAL
Labeler
Hetero Drugs Limited
Application
ANDA090061
Marketing category
ANDA
Marketing start
2010-06-07
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
65977-5025-02019-11-13C16284748780-197449f38-c7b5-f6ea-e053-dbdaa90aa703HIGHLIGHTS OF PRESCRIBING INFORMATION These 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 RX only
65977-5025-12019-11-13C16284748780-197449f38-c7b5-f6ea-e053-dbdaa90aa703HIGHLIGHTS OF PRESCRIBING INFORMATION These 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 RX only
65977-5025-22019-11-13C16284748780-197449f38-c7b5-f6ea-e053-dbdaa90aa703HIGHLIGHTS OF PRESCRIBING INFORMATION These 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 RX only
65977-5025-32019-11-13C16284748780-197449f38-c7b5-f6ea-e053-dbdaa90aa703HIGHLIGHTS OF PRESCRIBING INFORMATION These 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 RX only
65977-5025-42019-11-13C16284748780-197449f38-c7b5-f6ea-e053-dbdaa90aa703HIGHLIGHTS OF PRESCRIBING INFORMATION These 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 RX only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65977-5025-0Finasteride48 in 1 CONTAINERTABLET487
65977-5025-0Finasteride30 in 1 BOTTLETABLET307
65977-5025-1Finasteride48 in 1 CONTAINERTABLET487
65977-5025-1Finasteride100 in 1 BOTTLETABLET1007
65977-5025-2Finasteride48 in 1 CONTAINERTABLET487
65977-5025-2Finasteride1000 in 1 BOTTLETABLET10007
65977-5025-3Finasteride90 in 1 BOTTLETABLET907
65977-5025-3Finasteride48 in 1 CONTAINERTABLET487
65977-5025-4Finasteride48 in 1 CONTAINERTABLET487
65977-5025-4Finasteride500 in 1 BOTTLETABLET5007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET [HETERO DRUGS LIMITED]7
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET [HETERO DRUGS LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET [HETERO DRUGS LIMITED]7
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET [HETERO DRUGS LIMITED]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET [HETERO DRUGS LIMITED]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET [HETERO DRUGS LIMITED]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFINASTERIDE TABLET [HETERO DRUGS LIMITED]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET [HETERO DRUGS LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET [HETERO DRUGS LIMITED]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET [HETERO DRUGS LIMITED]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET [HETERO DRUGS LIMITED]7
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET [HETERO DRUGS LIMITED]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET [HETERO DRUGS LIMITED]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65977-5025FINASTERIDE TABLET [HETERO DRUGS LIMITED]7Legacy NDC, 10 package rows20120320_0c3b40ab-0dd9-4e1c-a8bc-bf2b36066314.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN0c3b40ab-0dd9-4e1c-a8bc-bf2b360663147
310346finasteride 5 MG Oral TabletSCD0c3b40ab-0dd9-4e1c-a8bc-bf2b360663147
310346FIN5C 5 MG Oral TabletSY0c3b40ab-0dd9-4e1c-a8bc-bf2b360663147

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65977-5025-06597750250048 in 1 CONTAINERHistorical
65977-5025-16597750250148 in 1 CONTAINERHistorical
65977-5025-26597750250248 in 1 CONTAINERHistorical
65977-5025-36597750250390 in 1 BOTTLEHistorical
65977-5025-46597750250448 in 1 CONTAINERHistorical