NDC Code(s) : 50436-6375-0
Packager : Unit Dose Services

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EscitalopramEscitalopram Oxalate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-6375(NDC:60505-2781)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE(UNII: 5U85DBW7LO)
(ESCITALOPRAM - UNII:4O4S742ANY) 		ESCITALOPRAM10 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (700000 MW)(UNII: U3JF91U133)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code APO;ESC;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50436-6375-0 30 in 1 BOTTLE Type 0: Not a Combination Product09/11/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078777 09/11/2012

PRINCIPAL DISPLAY PANEL

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