NDC Code(s) : 68001-512-06, 68001-513-06, 68001-514-06, 68001-515-06
Packager : Bluepoint Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

QUETIAPINE FUMARATEQUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-512
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)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
Product Characteristics
Color white Score no score
Shape ROUND (biconvex) Size 8 mm
Flavor Imprint Code I1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-512-0660 in 1 BOTTLE Type 0: Not a Combination Product31/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090681 08/31/2021
QUETIAPINE FUMARATEQUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-513
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)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape ROUND (Biconvex) Size 10 mm
Flavor Imprint Code I2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-513-0660 in 1 BOTTLE Type 0: Not a Combination Product31/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090681 08/31/2021
QUETIAPINE FUMARATEQUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-514
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)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow (light yellow) Score no score
Shape ROUND (Biconvex) Size 11 mm
Flavor Imprint Code I3
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-514-0660 in 1 BOTTLE Type 0: Not a Combination Product31/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090681 08/31/2021
QUETIAPINE FUMARATEQUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-515
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
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Product Characteristics
Color white Score no score
Shape ROUND (Biconvex beveled edge) Size 13 mm
Flavor Imprint Code I4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-515-0660 in 1 BOTTLE Type 0: Not a Combination Product31/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090681 08/31/2021

LABELER - Bluepoint Laboratories(985523874)

Establishment
Name Address ID/FEI Business Operations
Intas Pharmaceuticals Limited 725927649 manufacture(68001-512, 68001-513, 68001-514, 68001-515), analysis(68001-512, 68001-513, 68001-514, 68001-515), pack(68001-512, 68001-513, 68001-514, 68001-515)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 68001-512-06

Quetiapine Extended-release Tablets USP150 mg*       

Once Daily

Rx Only

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

60 Tablets

Quetiapin Extended-Release tablets 150mg(NDC 68001-512-06)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 68001-513-06

Quetiapine Extended-release Tablets USP200 mg*     

Once Daily

Rx Only

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

60 Tablets

Quetiapine Extended-Release Tablets 200mg (NDC 68001-513-06)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 68001-514-06

Quetiapine Extended-release Tablets USP300 mg*     

Once Daily

Rx Only

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

60 Tablets

Quetiapine Extended-Release Tablets 300mg (NDC 68001-514-06)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 68001-515-06

Quetiapine Extended-release Tablets USP400 mg*     

Once Daily

Rx Only

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

60 Tablets

Quetiapine Extended-Release Tablets 400mg (NDC 68001-515-06)