NDC Code(s) : 68645-448-70, 68645-447-70
Packager : Legacy Pharmaceutical Packaging, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EscitalopramEscitalopram TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-448(NDC:31722-250)
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2208 (3 MPA.S)(UNII: 9H4L916OBU)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code 250;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68645-448-7030 in 1 BLISTER PACK Type 0: Not a Combination Product11/09/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078604 09/11/2012 05/31/2018
EscitalopramEscitalopram TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-447(NDC:31722-251)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE(UNII: 5U85DBW7LO)
(ESCITALOPRAM - UNII:4O4S742ANY) 		ESCITALOPRAM20 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2208 (3 MPA.S)(UNII: 9H4L916OBU)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code 251;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68645-447-7030 in 1 BLISTER PACK Type 0: Not a Combination Product11/09/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078604 09/11/2012 06/30/2018

PRINCIPAL DISPLAY PANEL

 Escitalopram Tablets, USP 10mg

PRINCIPAL DISPLAY PANEL

 Escitalopram Tablets, USP 20mg