NDC Code(s) : 24658-140-30, 24658-140-01, 24658-140-10, 24658-141-30, 24658-141-01, 24658-141-10, 24658-142-30, 24658-142-01, 24658-142-10
Packager : PuraCap Laboratories LLC dba Blu Pharmaceuticals

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:24658-140
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
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color YELLOW (Beige) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 206;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24658-140-3030 in 1 BOTTLE Type 0: Not a Combination Product03/04/2007
2NDC:24658-140-01100 in 1 BOTTLE Type 0: Not a Combination Product03/04/2007
3NDC:24658-140-101000 in 1 BOTTLE Type 0: Not a Combination Product03/04/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077534 04/03/2007 01/31/2016
CitalopramCitalopram TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-141
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
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code 207;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24658-141-3030 in 1 BOTTLE Type 0: Not a Combination Product03/04/2007
2NDC:24658-141-01100 in 1 BOTTLE Type 0: Not a Combination Product03/04/2007
3NDC:24658-141-101000 in 1 BOTTLE Type 0: Not a Combination Product03/04/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077534 04/03/2007 01/31/2016
CitalopramCitalopram TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-142
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
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code 208;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24658-142-3030 in 1 BOTTLE Type 0: Not a Combination Product03/04/2007
2NDC:24658-142-01100 in 1 BOTTLE Type 0: Not a Combination Product03/04/2007
3NDC:24658-142-101000 in 1 BOTTLE Type 0: Not a Combination Product03/04/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077534 04/03/2007 01/31/2016

PRINCIPAL DISPLAY PANEL

Citalopram Tablets USP

10 mg - 30s Count Container Label

citalopram-tablets-usp-6

PRINCIPAL DISPLAY PANEL

Citalopram Tablets USP

20 mg - 30s Count Container Label

citalopram-tablets-usp-7

PRINCIPAL DISPLAY PANEL

Citalopram Tablets USP

40 mg - 30s Count Container Label

citalopram-tablets-usp-8