Quetiapine
These highlights do not include all the information needed to use QUETIAPINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE EXTENDED-RELEASE TABLETS.QUETIAPINE extended-release tablets for oral useInitial U.S. Approval: 1997
Approved
Approval ID
07e4f3f4-42cb-4b22-bf8d-8c3279d26e97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2021
Manufacturers
FDA
ACI Healthcare USA, Inc.
DUNS: 080430318
Products 5
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 Code71093-138
Application NumberANDA209635
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2020
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 300 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
Quetiapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71093-137
Application NumberANDA209635
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2020
FDA Product Classification
INGREDIENTS (9)
QUETIAPINE FUMARATEActive
Quantity: 200 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Quetiapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71093-136
Application NumberANDA209635
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2020
FDA Product Classification
INGREDIENTS (8)
QUETIAPINE FUMARATEActive
Quantity: 150 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Quetiapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71093-139
Application NumberANDA209635
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2020
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 400 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Quetiapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71093-135
Application NumberANDA209635
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quetiapine
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2020
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 50 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT