Citalopram, Page 6

Citalopram hydrobromide is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram tablets are indicated for the treatment of depression.

Principal Display Panel — 40 mg Blister

Citalopram

Tablets USP

40 mg

BlisterBlister

Principal Display Panel — 40 mg Carton

0093-4742-05 (TEVA)

Citalopram

Tablets USP

40 mg

QTY 30

Citalopram 40 mg carton
(click image for full-size original)

Principal Display Panel — 10 mg Bag

Citalopram Tablets USP

10 mg*

10 Tablets

Bag Label
(click image for full-size original)

Principal Display Panel — 20 mg Bag

Citalopram Tablets USP

20 mg*

10 Tablets

Bag Label
(click image for full-size original)

Principal Display Panel — 40 mg Bag

Citalopram Tablets USP

40 mg*

10 Tablets

Bag Label
(click image for full-size original)
CITALOPRAM
citalopram tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-8266(NDC:0093-4740)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE (CITALOPRAM) CITALOPRAM 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POVIDONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (light beige) Score no score
Shape OVAL (capsule-shaped) Size 11mm
Flavor Imprint Code 4740;93
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-8266-9 6 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 5 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (55154-8266-9)
2 NDC:55154-8266-0 10 BLISTER PACK (BLISTER PACK) in 1 BAG contains a BLISTER PACK
2 1 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the BAG (55154-8266-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077048 01/19/2011
CITALOPRAM
citalopram tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-8267(NDC:0093-4741)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE (CITALOPRAM) CITALOPRAM 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POVIDONE
FD&C RED NO. 40
ALUMINUM OXIDE
FD&C YELLOW NO. 6
Product Characteristics
Color PINK (light pink) Score 2 pieces
Shape OVAL (capsule-shaped) Size 11mm
Flavor Imprint Code 4741;9;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-8267-9 6 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 5 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (55154-8267-9)
2 NDC:55154-8267-0 10 BLISTER PACK (BLISTER PACK) in 1 BAG contains a BLISTER PACK
2 1 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the BAG (55154-8267-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077048 01/19/2011
CITALOPRAM
citalopram tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-8269(NDC:0093-4742)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE (CITALOPRAM) CITALOPRAM 40 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POVIDONE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL (capsule-shaped) Size 11mm
Flavor Imprint Code 4742;9;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-8269-9 6 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 5 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (55154-8269-9)
2 NDC:55154-8269-0 10 BLISTER PACK (BLISTER PACK) in 1 BAG contains a BLISTER PACK
2 1 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the BAG (55154-8269-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077048 01/19/2011
Labeler — Cardinal Health (188557102)
Establishment
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK

Revised: 06/2011 Cardinal Health

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