Finasteride

Product NDC
69097-112
11-digit product format
690970112
Labeler code
69097
Product ID
69097-112_1f0cca72-092c-456d-b7b2-c94ef16e0ccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077335
Marketing category
ANDA
Marketing start
2014-11-20
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-112-02EA - Each69097-11217c3bbe9-8e05-4895-9341-6627d56d530712015-07-20
69097-112-05EA - Each69097-112e36cab46-65c6-4c19-a638-4cee6ec69a4912015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET [CIPLA USA INC.]1
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET [CIPLA USA INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FINASTERIDE TABLET [CIPLA USA INC.]1
DOCUSATE SODIUM/SODIUM BENZOATEINACTIVE INGREDIENT656HXR6YXNFINASTERIDE TABLET [CIPLA USA INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET [CIPLA USA INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFINASTERIDE TABLET [CIPLA USA INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FINASTERIDE TABLET [CIPLA USA INC.]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WFINASTERIDE TABLET [CIPLA USA INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET [CIPLA USA INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET [CIPLA USA INC.]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEFINASTERIDE TABLET [CIPLA USA INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET [CIPLA USA INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET [CIPLA USA INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET [CIPLA USA INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-112FINASTERIDE TABLET [CIPLA USA INC.]3Legacy NDC20181212_81b424d3-8418-4497-9395-59eae6755230.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-112-026909701120230 TABLET in 1 BOTTLE (69097-112-02) 30 tablet2014-11-200000-00-00NoNoCurrent
69097-112-056909701120590 TABLET in 1 BOTTLE (69097-112-05) 90 tablet2014-11-200000-00-00NoNoCurrent