Finasteride

Product NDC
65862-927
11-digit product format
658620927
Labeler code
65862
Product ID
65862-927_92ac09b3-d036-4c90-81e6-c13310f0a673
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203687
Marketing category
ANDA
Marketing start
2014-09-20
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
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
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
65862-927-30Finasteride30 in 1 BOTTLETABLET, FILM COATED3013
65862-927-90Finasteride90 in 1 BOTTLETABLET, FILM COATED9013
65862-927-99Finasteride1000 in 1 BOTTLETABLET, FILM COATED100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-927-30EA - Each65862-927e59380f4-7849-4149-a118-2d3aa7ad413912014-11-05
65862-927-90EA - Each65862-9275174ee75-e742-453b-95b0-0f8f938a385012014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-927FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 3 package rows20240426_7d140366-2388-488e-bd86-67e6edf44345.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSN7d140366-2388-488e-bd86-67e6edf4434513
200172finasteride 1 MG Oral TabletSCD7d140366-2388-488e-bd86-67e6edf4434513
200172FIN5C 1 MG Oral TabletSY7d140366-2388-488e-bd86-67e6edf4434513
200172finasteride 1 MG Oral TabletPSN74b90430-8ce1-470c-939c-685ca9dfd74f11
200172finasteride 1 MG Oral TabletSCD74b90430-8ce1-470c-939c-685ca9dfd74f11
200172FIN5C 1 MG Oral TabletSY74b90430-8ce1-470c-939c-685ca9dfd74f11
200172finasteride 1 MG Oral TabletPSN8488cd17-365c-701c-e053-2991aa0af5f93
200172finasteride 1 MG Oral TabletSCD8488cd17-365c-701c-e053-2991aa0af5f93
200172FIN5C 1 MG Oral TabletSY8488cd17-365c-701c-e053-2991aa0af5f93
200172finasteride 1 MG Oral TabletPSNf477dc5b-1c53-4866-bcba-8e26b2873a2b2
200172finasteride 1 MG Oral TabletSCDf477dc5b-1c53-4866-bcba-8e26b2873a2b2
200172FIN5C 1 MG Oral TabletSYf477dc5b-1c53-4866-bcba-8e26b2873a2b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-927-306586209273030 TABLET, FILM COATED in 1 BOTTLE (65862-927-30) 2014-09-200000-00-00NoNoCurrent
65862-927-906586209279090 TABLET, FILM COATED in 1 BOTTLE (65862-927-90) 2014-09-200000-00-00NoNoCurrent
65862-927-99658620927991000 TABLET, FILM COATED in 1 BOTTLE (65862-927-99) 2014-09-200000-00-00NoNoCurrent