FINASTERIDE

Product NDC
47335-715
11-digit product format
473350715
Labeler code
47335
Product ID
47335-715_4e0042bf-4c11-4c49-98c1-27c714e17149
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FINASTERIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090507
Marketing category
ANDA
Marketing start
2022-11-25
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-715-13EA - Each47335-71509558343-45c5-46b3-9315-a50b870471ee12012-07-24
47335-715-81EA - Each47335-7152809b031-466c-4180-b814-faf7b2373f9d12012-07-24
47335-715-83EA - Each47335-715ac9a8d9f-4fa0-4be5-9e26-73d6e793e4b612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-715FINASTERIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Legacy NDC20221125_f149569c-05d1-4dba-b35a-4ed6a633f776.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-715-0847335071508100 TABLET, FILM COATED in 1 BOTTLE (47335-715-08) 2022-11-250000-00-00NoNoCurrent
47335-715-1347335071513500 TABLET, FILM COATED in 1 BOTTLE (47335-715-13) 2022-11-250000-00-00NoNoCurrent
47335-715-18473350715181000 TABLET, FILM COATED in 1 BOTTLE (47335-715-18) 2022-11-250000-00-00NoNoCurrent
47335-715-814733507158190 TABLET, FILM COATED in 1 BOTTLE (47335-715-81) 2022-11-250000-00-00NoNoCurrent
47335-715-834733507158330 TABLET, FILM COATED in 1 BOTTLE (47335-715-83) 2022-11-250000-00-00NoNoCurrent
47335-715-8847335071588100 TABLET, FILM COATED in 1 BOTTLE (47335-715-88) 2022-11-250000-00-00NoNoCurrent