NDC Code(s) : 68001-598-06, 68001-599-06, 68001-600-06, 68001-601-06, 68001-602-06
Packager : BluePoint Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

QuetiapineQuetiapine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-598
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)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color pink (peach) Score no score
Shape CAPSULE (biconvex, intagliated) Size 12 mm
Flavor Imprint Code 74;U
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-598-0660 in 1 BOTTLE Type 0: Not a Combination Product11/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215478 11/01/2023
QuetiapineQuetiapine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-599
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)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
Product Characteristics
Color white Score no score
Shape CAPSULE (biconvex, intagliated) Size 15 mm
Flavor Imprint Code 72;U
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-599-0660 in 1 BOTTLE Type 0: Not a Combination Product11/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215478 11/01/2023
QuetiapineQuetiapine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-600
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)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape CAPSULE (biconvex, intagliated) Size 17 mm
Flavor Imprint Code 73;U
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-600-0660 in 1 BOTTLE Type 0: Not a Combination Product11/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215478 11/01/2023
QuetiapineQuetiapine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-601
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)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow (pale yellow) Score no score
Shape CAPSULE (biconvex, intagliated) Size 19 mm
Flavor Imprint Code 75;U
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-601-0660 in 1 BOTTLE Type 0: Not a Combination Product11/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215478 11/01/2023
QuetiapineQuetiapine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-602
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)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
Product Characteristics
Color white Score no score
Shape CAPSULE (biconvex, intagliated) Size 19 mm
Flavor Imprint Code 77;U
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-602-0660 in 1 BOTTLE Type 0: Not a Combination Product11/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215478 11/01/2023

LABELER - BluePoint Laboratories(985523874)

REGISTRANT - Unichem Laboratories Limited, India(650055882)

Establishment
Name Address ID/FEI Business Operations
Unichem Laboratories Limited 915389741 analysis(68001-598, 68001-599, 68001-600, 68001-601, 68001-602), manufacture(68001-598, 68001-599, 68001-600, 68001-601, 68001-602), pack(68001-598, 68001-599, 68001-600, 68001-601, 68001-602), label(68001-598, 68001-599, 68001-600, 68001-601, 68001-602)

PRINCIPAL DISPLAY PANEL

Quetiapine ER tab 50mgQuetiapine ER tab 50mgQuetiapine ER tab 50mgQuetiapine ER tab 50mgQuetiapine ER tab 50mg