Quetiapine Fumarate (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 25 mg

Quetiapine Fumarate Tablets 25 mg (30 Tablets in 1 Bottle)
Each coated tablet contains quetiapine fumarate equivalent to 25 mg of quetiapine46708-134-30

25 mg 30's bottle pack
(click image for full-size original)

25 mg 30’s bottle pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 50 mg

Quetiapine Fumarate Tablets 50 mg (30 Tablets in 1 Bottle)
Each coated tablet contains quetiapine fumarate equivalent to 50 mg of quetiapine 46708-135-30

50 mg 30's bottle pack
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 100 mg

Quetiapine Fumarate Tablets 100 mg (30 Tablets in 1 Bottle)
Each coated tablet contains quetiapine fumarate equivalent to 100 mg of quetiapine 46708-136-30

100 mg 30's bottle pack
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 200 mg

Quetiapine Fumarate Tablets 200 mg (30 Tablets in 1 Bottle)
Each coated tablet contains quetiapine fumarate equivalent to 200 mg of quetiapine 46708-137-30

200 mg 30's bottle pack
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 300 mg

Quetiapine Fumarate Tablets 300 mg (30 Tablets in 1 Bottle)
Each coated tablet contains quetiapine fumarate equivalent to 300 mg of quetiapine 46708-138-30

300 mg 30's bottle pack
(click image for full-size original)

300 mg 30’s bottle pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 400 mg

Quetiapine Fumarate Tablets 400 mg (30 Tablets in 1 Bottle)
Each coated tablet contains quetiapine fumarate equivalent to 400 mg of quetiapine 46708-139-30

400 mg 30's bottle pack
(click image for full-size original)
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-134
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Round, biconvex) Size 5mm
Flavor Imprint Code 224;L
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-134-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-134-31 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-134-91 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-134-10 100 TABLET, FILM COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203390 02/21/2017
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-135
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Round, biconvex) Size 7mm
Flavor Imprint Code 225;L
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-135-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-135-31 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-135-91 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-135-10 100 TABLET, FILM COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203390 02/21/2017
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-136
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Round, biconvex) Size 9mm
Flavor Imprint Code 226;L
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-136-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-136-31 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-136-91 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-136-10 100 TABLET, FILM COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203390 02/21/2017
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-137
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Round, biconvex) Size 11mm
Flavor Imprint Code L227
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-137-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-137-31 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-137-91 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-137-10 100 TABLET, FILM COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203390 02/21/2017
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-138
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE (Capsule shaped, biconvex) Size 18mm
Flavor Imprint Code L228
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-138-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-138-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-138-91 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-138-10 100 TABLET, FILM COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203390 02/21/2017
QUETIAPINE FUMARATE quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-139
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE (Capsule shaped, biconvex) Size 19mm
Flavor Imprint Code L229
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-139-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-139-31 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-139-71 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-139-10 100 TABLET, FILM COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203390 02/21/2017
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-134), MANUFACTURE (46708-135), MANUFACTURE (46708-136), MANUFACTURE (46708-137), MANUFACTURE (46708-138), MANUFACTURE (46708-139)

Revised: 09/2019 Alembic Pharmaceuticals Limited

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