QUETIAPINE FUMARATE (Page 13 of 13)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quetiapine Tablets, USP 25 mg

25
(click image for full-size original)

Quetiapine Tablets, USP 50 mg

50
(click image for full-size original)

Quetiapine Tablets, USP 100 mg

100
(click image for full-size original)

Quetiapine Tablets, USP 200 mg

200
(click image for full-size original)

Quetiapine Tablets, USP 300 mg

300
(click image for full-size original)

Quetiapine Tablets, USP 400 mg

400
(click image for full-size original)
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-148
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
CELLULOSE, MICROCRYSTALLINE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color red (Brownish Red) Score no score
Shape ROUND (Round) Size 5mm
Flavor Imprint Code 48
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-148-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-148-42 6000 TABLET in 1 BOTTLE None
3 NDC:13668-148-10 1000 TABLET in 1 BOTTLE None
4 NDC:13668-148-01 100 TABLET in 1 BOTTLE None
5 NDC:13668-148-05 500 TABLET in 1 BOTTLE None
6 NDC:13668-148-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200363 03/27/2012
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-149
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white (White to off White) Score no score
Shape ROUND (Round) Size 7mm
Flavor Imprint Code 49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-149-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-149-01 100 TABLET in 1 BOTTLE None
3 NDC:13668-149-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-149-10 1000 TABLET in 1 BOTTLE None
5 NDC:13668-149-58 4500 TABLET in 1 BOTTLE None
6 NDC:13668-149-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200363 03/27/2012
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-150
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white (White to off White) Score no score
Shape ROUND (Round) Size 9mm
Flavor Imprint Code 1150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-150-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-150-05 500 TABLET in 1 BOTTLE None
3 NDC:13668-150-01 100 TABLET in 1 BOTTLE None
4 NDC:13668-150-74 100 TABLET in 1 CARTON None
5 NDC:13668-150-20 2000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200363 03/27/2012
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-151
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND (Round) Size 11mm
Flavor Imprint Code 1151
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-151-74 100 TABLET in 1 CARTON None
2 NDC:13668-151-15 1500 TABLET in 1 BOTTLE None
3 NDC:13668-151-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-151-01 100 TABLET in 1 BOTTLE None
5 NDC:13668-151-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200363 03/27/2012
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-152
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off white) Score no score
Shape CAPSULE (Capsule) Size 19mm
Flavor Imprint Code 1152
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-152-74 100 TABLET in 1 CARTON None
2 NDC:13668-152-31 2500 TABLET in 1 BOTTLE None
3 NDC:13668-152-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-152-01 100 TABLET in 1 BOTTLE None
5 NDC:13668-152-60 60 TABLET in 1 BOTTLE None
6 NDC:13668-152-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200363 03/27/2012
QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-153
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND (Round) Size 14mm
Flavor Imprint Code 1153
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-153-74 100 TABLET in 1 CARTON None
2 NDC:13668-153-20 2000 TABLET in 1 BOTTLE None
3 NDC:13668-153-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-153-01 100 TABLET in 1 BOTTLE None
5 NDC:13668-153-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200363 03/27/2012
Labeler — TORRENT PHARMACEUTICALS LIMITED (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
TORRENT PHARMACEUTICALS LIMITED 916488547 manufacture (13668-148), manufacture (13668-149), manufacture (13668-150), manufacture (13668-151), manufacture (13668-152), manufacture (13668-153)

Revised: 04/2021 TORRENT PHARMACEUTICALS LIMITED

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