Quetiapine Fumarate (Page 14 of 14)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP, 25 mg

NDC: 0054-0220-25

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP, 25 mg

NDC: 0054-0220-20

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP, 50 mg

NDC: 0054-0229-25

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP, 50 mg

NDC: 0054-0229-20

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP, 100 mg

NDC: 0054-0221-25

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP, 100 mg

NDC: 0054-0221-20

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP, 200 mg

NDC: 0054-0222-25

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP, 300 mg

NDC: 0054-0223-21

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP, 300 mg

NDC: 0054-0223-20

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP, 400 mg

NDC: 0054-0230-25

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QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0220
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE 25 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE, UNSPECIFIED FORM
WATER
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 54;137
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0220-31 1000 TABLET in 1 BOTTLE None
2 NDC:0054-0220-25 100 TABLET in 1 BOTTLE None
3 NDC:0054-0220-20 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0054-0220-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090120 03/27/2012
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0229
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
WATER
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 4mm
Flavor Imprint Code 54;377
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0229-31 1000 TABLET in 1 BOTTLE None
2 NDC:0054-0229-25 100 TABLET in 1 BOTTLE None
3 NDC:0054-0229-20 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0054-0229-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090749 03/27/2012
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0221
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
WATER
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 54;373
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0221-25 100 TABLET in 1 BOTTLE None
2 NDC:0054-0221-20 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0054-0221-20)
3 NDC:0054-0221-31 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090749 03/27/2012
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0222
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
WATER
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 54;527
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0222-25 100 TABLET in 1 BOTTLE None
2 NDC:0054-0222-20 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0054-0222-20)
3 NDC:0054-0222-29 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090749 03/27/2012
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0223
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
WATER
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 7mm
Flavor Imprint Code 54;531
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0223-21 60 TABLET in 1 BOTTLE None
2 NDC:0054-0223-20 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0054-0223-20)
3 NDC:0054-0223-29 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090749 03/27/2012
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0230
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE 400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
WATER
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 8mm
Flavor Imprint Code 54;735
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0230-25 100 TABLET in 1 BOTTLE None
2 NDC:0054-0230-20 10 BLISTER PACK in 1 BLISTER PACK contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the BLISTER PACK (0054-0230-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090749 03/27/2012
Labeler — West-Ward Pharmaceuticals Corp (080189610)
Establishment
Name Address ID/FEI Operations
West-Ward Columbus Inc. 058839929 MANUFACTURE (0054-0220), MANUFACTURE (0054-0229), MANUFACTURE (0054-0221), MANUFACTURE (0054-0222), MANUFACTURE (0054-0223), MANUFACTURE (0054-0230)

Revised: 09/2020 West-Ward Pharmaceuticals Corp

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