NDC Code(s) : 0179-0059-70
Packager : KAISER FOUNDATION HOSPITALS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Isosorbide DinitrateIsosorbide Dinitrate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0179-0059(NDC:64980-144)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOSORBIDE DINITRATE(UNII: IA7306519N)
(ISOSORBIDE DINITRATE - UNII:IA7306519N) 		ISOSORBIDE DINITRATE40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND (round) Size 11 mm
Flavor Imprint Code cor;183
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0179-0059-7030 in 1 BOX, UNIT-DOSE Type 0: Not a Combination Product25/03/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040723 03/25/2010 09/30/2011

PRINCIPAL DISPLAY PANEL

Container Label for 40mg, 100 Count