Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE FUMARATE 300 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM CITRATE
HYPROMELLOSE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
WATER
Product Characteristics
Color YELLOW (pale yellow) Score no score
Shape CAPSULE (biconvex, intagliated) Size 19mm
Flavor Imprint Code XR;300
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0310-0283-39 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK
1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0310-0283-39)
2 0310-0283-60 60 TABLET In 1 BOTTLE None
3 0310-0283-50 500 TABLET In 1 BOTTLE None
4 0310-0283-94 4 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022047 01/08/2010
SEROQUEL XR
quetiapine fumarate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0310-0284
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE FUMARATE 400 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM CITRATE
HYPROMELLOSE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
MAGNESIUM STEARATE
WATER
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (biconvex, intagliated) Size 19mm
Flavor Imprint Code XR;400
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0310-0284-39 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK
1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0310-0284-39)
2 0310-0284-60 60 TABLET In 1 BOTTLE None
3 0310-0284-94 4 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022047 01/08/2010
SEROQUEL XR
quetiapine fumarate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0310-0280
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE FUMARATE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM CITRATE
HYPROMELLOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
T |
