NDC Code(s) : 55154-6660-0, 55154-6661-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Citalopram Hydrobromidecitalopram hydrobromide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-6660(NDC:60505-2519)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
citalopram hydrobromide(UNII: I1E9D14F36)
(citalopram - UNII:0DHU5B8D6V) 		citalopram hydrobromide20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
lactose monohydrate(UNII: EWQ57Q8I5X)
magnesium stearate(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
polyethylene glycol(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color pink Score 2 pieces
Shape OVAL Size 8 mm
Flavor Imprint Code APO;CI;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-6660-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077046 11/24/2004
Citalopram Hydrobromidecitalopram hydrobromide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-6661(NDC:60505-2520)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
citalopram hydrobromide(UNII: I1E9D14F36)
(citalopram - UNII:0DHU5B8D6V) 		citalopram hydrobromide40 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
lactose monohydrate(UNII: EWQ57Q8I5X)
magnesium stearate(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
polyethylene glycol(UNII: 3WJQ0SDW1A)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 11 mm
Flavor Imprint Code APO;CI;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-6661-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077046 11/24/2004

PRINCIPAL DISPLAY PANEL

Citalopram HBr

20 mg*

10 Tablets

Bag label

PRINCIPAL DISPLAY PANEL

Citalopram HBr

40 mg*

10 Tablets

Bag Label