Quetiapine Fumarate (Page 13 of 13)

Quetiapine Fumarate

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Quetiapine Fumarate

Label Image
(click image for full-size original)

Quetiapine Fumarate

Label Image
(click image for full-size original)
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-665(NDC:0781-5344)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
HYPROMELLOSE, UNSPECIFIED
Product Characteristics
Color YELLOW (Biconvex) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code SZ;231
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-665-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-665-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078679 04/05/2013
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-677(NDC:0781-5346)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
PROPYLENE GLYCOL
Product Characteristics
Color WHITE (Biconvex) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code SZ;232
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-677-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-677-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078679 04/05/2013
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-690(NDC:0781-5347)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
PROPYLENE GLYCOL
Product Characteristics
Color WHITE (Biconvex) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code SZ;233
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-690-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-690-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078679 04/05/2013
Labeler — McKesson Corporation (140529962)
Establishment
Name Address ID/FEI Operations
McKesson Corporation 140529962 REPACK (63739-665), REPACK (63739-677), REPACK (63739-690)

Revised: 03/2018 McKesson Corporation

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