NDC Code(s) : 43547-280-10, 43547-280-11, 43547-281-10, 43547-281-11, 43547-282-10, 43547-282-11
Packager : SOLCO HEALTHCARE US, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EscitalopramEscitalopram TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-280
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE(UNII: 5U85DBW7LO)
(ESCITALOPRAM - UNII:4O4S742ANY) 		ESCITALOPRAM5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (biconvex) Size 6 mm
Flavor Imprint Code P;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-280-10100 in 1 BOTTLE Type 0: Not a Combination Product02/01/2016
2NDC:43547-280-111000 in 1 BOTTLE Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078032 02/01/2016
EscitalopramEscitalopram TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-281
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code P;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-281-10100 in 1 BOTTLE Type 0: Not a Combination Product02/01/2016
2NDC:43547-281-111000 in 1 BOTTLE Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078032 02/01/2016
EscitalopramEscitalopram TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-282
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND (biconvex) Size 9 mm
Flavor Imprint Code P;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-282-10100 in 1 BOTTLE Type 0: Not a Combination Product02/01/2016
2NDC:43547-282-111000 in 1 BOTTLE Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078032 02/01/2016

LABELER - SOLCO HEALTHCARE US, LLC(828343017)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - 5mg

NDC 43547-280-10

Escitalopram
Tablets, USP

5 mg

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

Rx only

100 Tablets

5

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - 10mg

NDC 43547-281-10

Escitalopram
Tablets, USP

10 mg

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

Rx only

100 Tablets

10

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - 20mg

NDC 43547-282-10

Escitalopram
Tablets, USP

20 mg

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

Rx only

100 Tablets

20