SEROQUEL (Page 13 of 13)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 25 mg

NDC 0310-0275-10 100 tablets

SeroQUEL®

(quetiapine) tablets

25 mg*

Rx only

Medication Guide must be

dispensed to patients.

AstraZeneca

Seroquel 25 mg 100 tablet bottle label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 50 mg

NDC 0310-0278-10 100 tablets

SeroQUEL®

(quetiapine) tablets

50 mg*

Rx only

Medication Guide must be

dispensed to patients.

AstraZeneca

Seroquel 50 mg 100 tablet bottle label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg

NDC 0310-0271-10 100 tablets

SeroQUEL®

(quetiapine) tablets

100 mg*

Rx only

Medication Guide must be

dispensed to patients.

AstraZeneca

Seroquel 100 mg 100 tablet bottle label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 200 mg

NDC 0310-0272-10 100 tablets

SeroQUEL®

(quetiapine) tablets

200 mg*

Rx only

Medication Guide must be

dispensed to patients.

AstraZeneca

Seroquel 200 mg 100 tablet bottle label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 300 mg

NDC 0310-0274-60 60 tablets

SeroQUEL®

(quetiapine) tablets

300 mg*

Rx only

Medication Guide must be

dispensed to patients.

AstraZeneca

Seroquel 300 mg 60 tablet bottle label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 400 mg

NDC 0310-0279-10 100 tablets

SeroQUEL®

(quetiapine) tablets

400 mg*

Rx only

Medication Guide must be

dispensed to patients.

AstraZeneca

Seroquel 400 mg 100 tablet bottle label
(click image for full-size original)
SEROQUEL
quetiapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0275
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
POVIDONE, UNSPECIFIED
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
WATER
Product Characteristics
Color PINK (peach) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code SEROQUEL;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-0275-10 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0310-0275-34 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0310-0275-39 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0310-0275-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020639 10/01/1997
SEROQUEL
quetiapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0278
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
POVIDONE, UNSPECIFIED
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
LACTOSE MONOHYDRATE
WATER
FERRIC OXIDE YELLOW
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 7mm
Flavor Imprint Code SEROQUEL;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-0278-10 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0310-0278-34 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0310-0278-39 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0310-0278-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020639 02/13/2006
SEROQUEL
quetiapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0271
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
POVIDONE, UNSPECIFIED
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
WATER
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code SEROQUEL;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-0271-10 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0310-0271-39 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0310-0271-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020639 10/01/1997
SEROQUEL
quetiapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0272
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
POVIDONE, UNSPECIFIED
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
WATER
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 11mm
Flavor Imprint Code SEROQUEL;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-0272-10 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0310-0272-39 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0310-0272-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020639 10/01/1997
SEROQUEL
quetiapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0274
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
POVIDONE, UNSPECIFIED
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
WATER
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (biconvex) Size 19mm
Flavor Imprint Code SEROQUEL;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-0274-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0310-0274-39 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0310-0274-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020639 11/13/2000
SEROQUEL
quetiapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0279
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
POVIDONE, UNSPECIFIED
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
WATER
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE (biconvex) Size 19mm
Flavor Imprint Code SEROQUEL;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-0279-10 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0310-0279-39 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0310-0279-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020639 02/13/2006
Labeler — AstraZeneca Pharmaceuticals LP (054743190)
Registrant — AstraZeneca PLC (230790719)

Revised: 01/2022 AstraZeneca Pharmaceuticals LP

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