NDC Code(s) : 65162-052-03, 65162-052-10, 65162-052-50, 65162-052-11, 65162-053-03, 65162-053-10, 65162-053-50, 65162-053-11, 65162-054-03, 65162-054-10, 65162-054-50, 65162-054-11
Packager : Amneal Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CitalopramCitalopram TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-052
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE(UNII: I1E9D14F36)
(CITALOPRAM - UNII:0DHU5B8D6V) 		CITALOPRAM10 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K12(UNII: 333AG72FWJ)
STARCH, CORN(UNII: O8232NY3SJ)
GLYCERIN(UNII: PDC6A3C0OX)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color orange Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code IP;52
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65162-052-0330 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
2NDC:65162-052-10100 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
3NDC:65162-052-50500 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
4NDC:65162-052-111000 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077289 04/06/2010
CitalopramCitalopram TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-053
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE(UNII: I1E9D14F36)
(CITALOPRAM - UNII:0DHU5B8D6V) 		CITALOPRAM20 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K12(UNII: 333AG72FWJ)
STARCH, CORN(UNII: O8232NY3SJ)
GLYCERIN(UNII: PDC6A3C0OX)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color pink Score 2 pieces
Shape OVAL Size 12 mm
Flavor Imprint Code IP;53
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65162-053-0330 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
2NDC:65162-053-10100 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
3NDC:65162-053-50500 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
4NDC:65162-053-111000 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077289 04/06/2010
CitalopramCitalopram TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-054
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE(UNII: I1E9D14F36)
(CITALOPRAM - UNII:0DHU5B8D6V) 		CITALOPRAM40 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K12(UNII: 333AG72FWJ)
STARCH, CORN(UNII: O8232NY3SJ)
GLYCERIN(UNII: PDC6A3C0OX)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 12 mm
Flavor Imprint Code IP;54
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65162-054-0330 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
2NDC:65162-054-10100 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
3NDC:65162-054-50500 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
4NDC:65162-054-111000 in 1 BOTTLE Type 0: Not a Combination Product04/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077289 04/06/2010

LABELER - Amneal Pharmaceuticals LLC(123797875)

PRINCIPAL DISPLAY PANEL

NDC 65162-052-50

Citalopram Tablets USP,  10 mg

Rx only

500 Tablets
Amneal Pharmaceuticals LLC

1

NDC 65162-053-50

Citalopram Tablets USP,  20 mg

Rx only

500 Tablets
Amneal Pharmaceuticals LLC

1
NDC 65162-054-50

Citalopram Tablets USP,  40 mg

Rx only

500 Tablets
Amneal Pharmaceuticals LLC

1