NDC Code(s) : 50228-380-30, 50228-380-60, 50228-380-10, 50228-381-30, 50228-381-60, 50228-381-10, 50228-382-30, 50228-382-60, 50228-382-10, 50228-383-30, 50228-383-60, 50228-383-05, 50228-384-30, 50228-384-60, 50228-384-05
Packager : ScieGen Pharmaceuticals, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Quetiapine Quetiapine TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-380
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color pink (Peach) Score no score
Shape CAPSULE (biconvex) Size 16 mm
Flavor Imprint Code 380
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-380-3030 in 1 BOTTLE Type 0: Not a Combination Product16/11/2018
2NDC:50228-380-6060 in 1 BOTTLE Type 0: Not a Combination Product16/11/2018
3NDC:50228-380-101000 in 1 BOTTLE Type 0: Not a Combination Product16/11/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209635 11/29/2017
Quetiapine Quetiapine TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-381
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE150 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape CAPSULE (biconvex) Size 17 mm
Flavor Imprint Code 381
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-381-3030 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
2NDC:50228-381-6060 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
3NDC:50228-381-101000 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209635 11/29/2017
Quetiapine Quetiapine TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-382
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape CAPSULE (biconvex) Size 17 mm
Flavor Imprint Code 382
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-382-3030 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
2NDC:50228-382-6060 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
3NDC:50228-382-101000 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209635 11/29/2017
Quetiapine Quetiapine TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-383
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow (pale yellow) Score no score
Shape CAPSULE (biconvex) Size 19 mm
Flavor Imprint Code 383
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-383-3030 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
2NDC:50228-383-6060 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
3NDC:50228-383-05500 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209635 11/29/2017
Quetiapine Quetiapine TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-384
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape CAPSULE (biconvex) Size 19 mm
Flavor Imprint Code 384
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-384-3030 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
2NDC:50228-384-6060 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
3NDC:50228-384-05500 in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209635 11/29/2017

LABELER - ScieGen Pharmaceuticals, Inc(079391286)

Establishment
Name Address ID/FEI Business Operations
ScieGen Pharmaceuticals, Inc 079391286 manufacture(50228-380, 50228-381, 50228-382, 50228-383, 50228-384), analysis(50228-380, 50228-381, 50228-382, 50228-383, 50228-384)

PRINCIPAL DISPLAY PANEL

NDC 50228-380-60

Quetiapine
Extended-Release
Tablets, USP

50 mg Once Daily

Dispense the accompanying
Medication Guide to each patient.

60 Tablets           Rx Only

ScieGen Pharmaceuticals, Inc.

Quetiapine Fumarate 50 mg 30 Count Bottle Label

NDC 50228-381-60

Quetiapine
Extended-Release
Tablets, USP

150 mg Once Daily

Dispense the accompanying
Medication Guide to each patient.

60 Tablets           Rx Only

ScieGen Pharmaceuticals, Inc.

Quetiapine Fumarate 50 mg 30 Count Bottle Label

NDC 50228-382-60

Quetiapine
Extended-Release
Tablets, USP

200 mg Once Daily

Dispense the accompanying
Medication Guide to each patient.

60 Tablets           Rx Only

ScieGen Pharmaceuticals, Inc.

Quetiapine Fumarate 50 mg 30 Count Bottle Label

NDC 50228-383-60

Quetiapine
Extended-Release
Tablets, USP

300 mg Once Daily

Dispense the accompanying
Medication Guide to each patient.

60 Tablets           Rx Only

ScieGen Pharmaceuticals, Inc.

Quetiapine Fumarate 50 mg 30 Count Bottle Label

NDC 50228-384-60

Quetiapine
Extended-Release
Tablets, USP

400 mg Once Daily

Dispense the accompanying
Medication Guide to each patient.

60 Tablets           Rx Only

ScieGen Pharmaceuticals, Inc.

Quetiapine Fumarate 50 mg 30 Count Bottle Label