NDC Code(s) : 60429-371-01, 60429-371-10, 60429-372-10, 60429-372-01, 60429-373-01, 60429-373-10, 60429-374-01, 60429-374-10, 60429-375-60, 60429-376-01
Packager : Golden State Medical Supply, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

quetiapine fumaratequetiapine fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-371(NDC:60505-3130)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FUMARIC ACID(UNII: 88XHZ13131)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color PINK (peach) Score no score
Shape ROUND (biconvex) Size 5 mm
Flavor Imprint Code APO;QUE;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-371-01100 in 1 BOTTLE Type 0: Not a Combination Product27/03/2012
2NDC:60429-371-101000 in 1 BOTTLE Type 0: Not a Combination Product27/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090960 03/27/2012 10/31/2016
quetiapine fumaratequetiapine fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-372(NDC:60505-3132)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FUMARIC ACID(UNII: 88XHZ13131)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 6 mm
Flavor Imprint Code APO;QUE;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-372-101000 in 1 BOTTLE Type 0: Not a Combination Product27/03/2012
2NDC:60429-372-01100 in 1 BOTTLE Type 0: Not a Combination Product27/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090960 03/27/2012 10/31/2016
quetiapine fumaratequetiapine fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-373(NDC:60505-3133)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FUMARIC ACID(UNII: 88XHZ13131)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 8 mm
Flavor Imprint Code APO;QUE;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-373-01100 in 1 BOTTLE Type 0: Not a Combination Product27/03/2012
2NDC:60429-373-101000 in 1 BOTTLE Type 0: Not a Combination Product27/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090960 03/27/2012 10/31/2016
quetiapine fumaratequetiapine fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-374(NDC:60505-3135)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FUMARIC ACID(UNII: 88XHZ13131)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 10 mm
Flavor Imprint Code APO;QUE;200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-374-01100 in 1 BOTTLE Type 0: Not a Combination Product27/03/2012
2NDC:60429-374-101000 in 1 BOTTLE Type 0: Not a Combination Product27/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090960 03/27/2012 10/31/2016
quetiapine fumaratequetiapine fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-375(NDC:60505-3137)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE300 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FUMARIC ACID(UNII: 88XHZ13131)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (biconvex) Size 17 mm
Flavor Imprint Code APO;QUE300
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-375-6060 in 1 BOTTLE Type 0: Not a Combination Product27/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090960 03/27/2012 05/31/2016
quetiapine fumaratequetiapine fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-376(NDC:60505-3139)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE400 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FUMARIC ACID(UNII: 88XHZ13131)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE (biconvex) Size 17 mm
Flavor Imprint Code APO;QUE400
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-376-01100 in 1 BOTTLE Type 0: Not a Combination Product27/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090960 03/27/2012 07/31/2016

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60429-371-01

Quetiapine Fumarate Tablets

25 mg

Rx only

100 Tablets

Label Graphic- 25MG 100s

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60429-372-01

Quetiapine Fumarate Tablets

50 mg

Rx only

100 Tablets

Label Graphic- 50mg 100s

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60429-373-01

Quetiapine Fumarate Tablets

100 mg

Rx only

100 Tablets

Label Graphic- 200mg 100s

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60429-374-01

Quetiapine Fumarate Tablets

200 mg

Rx only

100 Tablets

Label Graphic- 200mg 100s

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60429-375-60

Quetiapine Fumarate Tablets

300 mg

Rx only

60 Tablets

Label Graphic- 300Mg 60s

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section for complete listing): 

APOTEX CORP. NDC 60429-376-01

Quetiapine Fumarate Tablets

400 mg

Rx only

100 Tablets

Label Graphic- 400mg 100s