Quetiapine
These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
f9d265a9-7491-48e1-a39e-0aaa67294cff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2022
Manufacturers
FDA
Northstar RxLLC
DUNS: 830546433
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Quetiapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-455
Application NumberANDA202152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2022
FDA Product Classification
INGREDIENTS (10)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 200 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
Quetiapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-453
Application NumberANDA202152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2022
FDA Product Classification
INGREDIENTS (10)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 50 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
Quetiapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-456
Application NumberANDA202152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2022
FDA Product Classification
INGREDIENTS (10)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 300 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Quetiapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-454
Application NumberANDA202152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2022
FDA Product Classification
INGREDIENTS (11)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 100 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Quetiapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-457
Application NumberANDA202152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2022
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 400 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Quetiapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-452
Application NumberANDA202152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2022
FDA Product Classification
INGREDIENTS (12)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 25 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT