ITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
WATER
Product Characteristics
Color PINK (peach) Score no score
Shape CAPSULE (biconvex) Size 16mm
Flavor Imprint Code XR;50
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0310-0280-60 60 TABLET In 1 BOTTLE None
2 0310-0280-50 500 TABLET In 1 BOTTLE None
3 0310-0280-39 100 TABLET In 1 BOX, UNIT-DOSE 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) 0310-0281
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE FUMARATE 150 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM CITRATE
HYPROMELLOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
WATER
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (biconvex) Size 17mm
Flavor Imprint Code XR;150
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0310-0281-39 100 CAPSULE In 1 DOSE PACK None
2 0310-0281-50 500 CAPSULE In 1 BOTTLE None
3 0310-0281-60 60 CAPSULE In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022047 01/08/2010
Labeler - AstraZeneca Pharmaceuticals LP (054743190)
Registrant - AstraZeneca PLC (230790719)
Establishment
Name Address ID/FEI Operations
AstraZeneca Pharmaceuticals LP 054743190 MANUFACTURE, RELABEL, REPACK
Establishment
Name Address ID/FEI Operations
AstraZeneca UK Limited 232784079 MANUFACTURE
Establishment
Name Address ID/FEI Operations
AstraZeneca UK Ltd. Avlon Works 211222774 API MANUFACTURE
Revised: 12/2009 AstraZeneca Pharmaceuticals LP
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