Quetiapine Fumarate
These highlights do not include all the information needed to use QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS.QUETIAPINE FUMARATE extended-release tablets, for oral useInitial U.S. Approval: 1997
Approved
Approval ID
b56d057a-f5d9-4919-a0f2-b96a76ff83b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2019
Manufacturers
FDA
SpecGx LLC
DUNS: 080679498
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Quetiapine Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-1181
Application NumberANDA202939
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2014
FDA Product Classification
INGREDIENTS (10)
QUETIAPINE FUMARATEActive
Quantity: 150 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Quetiapine Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-1184
Application NumberANDA202939
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2014
FDA Product Classification
INGREDIENTS (10)
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 400 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Quetiapine Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-1183
Application NumberANDA202939
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2014
FDA Product Classification
INGREDIENTS (12)
QUETIAPINE FUMARATEActive
Quantity: 300 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Quetiapine Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-1182
Application NumberANDA202939
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2014
FDA Product Classification
INGREDIENTS (12)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 200 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Quetiapine Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-1180
Application NumberANDA202939
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2014
FDA Product Classification
INGREDIENTS (13)
QUETIAPINE FUMARATEActive
Quantity: 50 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT