Prescription Drug Information: Quetiapine Fumarate (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

quetiapinefumaratetablets25mg-100’s count

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quetiapinefumaratetablets50mg-100’s count

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quetiapinefumaratetablets200mg-100’s count

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quetiapinefumaratetablets300mg-60’s count

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quetiapinefumaratetablets 400mg-100’s count

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QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-764
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color pink (peach) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 44;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-764-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:31722-764-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:31722-764-32 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-764-31)
3 NDC:31722-764-31 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-764-32)
4 NDC:31722-764-34 150 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-764-33)
4 NDC:31722-764-33 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-764-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204316 06/16/2022
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-765
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND (biconvex) Size 7mm
Flavor Imprint Code 47;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-765-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:31722-765-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:31722-765-32 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-765-31)
3 NDC:31722-765-31 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-765-32)
4 NDC:31722-765-34 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-765-33)
4 NDC:31722-765-33 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-765-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204316 06/16/2022
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-766
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code 55;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-766-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:31722-766-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:31722-766-32 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-766-31)
3 NDC:31722-766-31 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-766-32)
4 NDC:31722-766-34 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-766-33)
4 NDC:31722-766-33 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-766-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204316 06/16/2022
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-767
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND (biconvex) Size 11mm
Flavor Imprint Code 56;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-767-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:31722-767-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:31722-767-32 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-767-31)
3 NDC:31722-767-31 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-767-32)
4 NDC:31722-767-34 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-767-33)
4 NDC:31722-767-33 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-767-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204316 06/16/2022
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-768
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE (biconvex) Size 19mm
Flavor Imprint Code 45;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-768-01 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:31722-768-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:31722-768-32 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-768-31)
3 NDC:31722-768-31 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-768-32)
4 NDC:31722-768-34 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-768-33)
4 NDC:31722-768-33 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-768-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204316 06/16/2022
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-769
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape CAPSULE (biconvex) Size 19mm
Flavor Imprint Code 57;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-769-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:31722-769-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:31722-769-32 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-769-31)
3 NDC:31722-769-31 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-769-32)
4 NDC:31722-769-34 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (31722-769-33)
4 NDC:31722-769-33 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-769-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204316 06/16/2022
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit V 650452530 manufacture (31722-764), manufacture (31722-765), manufacture (31722-766), manufacture (31722-767), manufacture (31722-768), manufacture (31722-769)
Establishment
Name Address ID/FEI Operations
Evaric Pharmaceuticals Inc 080470330 analysis (31722-764), analysis (31722-765), analysis (31722-766), analysis (31722-767), analysis (31722-768), analysis (31722-769), manufacture (31722-764), manufacture (31722-765), manufacture (31722-766), manufacture (31722-767), manufacture (31722-768), manufacture (31722-769)

Revised: 02/2024 Camber Pharmaceuticals, Inc.

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