SEROQUEL
These highlights do not include all the information needed to use SEROQUEL safely and effectively. See full prescribing information for SEROQUEL. SEROQUEL (quetiapine fumarate) Tablets Initial U.S. Approval: 1997
Approved
Approval ID
235f367b-544a-4523-a7bf-a9e2b3aa6fa0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 4
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 Code54868-4961
Application NumberNDA020639
Product Classification
M
Marketing Category
C73594
G
Generic Name
Quetiapine fumarate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2012
FDA Product Classification
INGREDIENTS (13)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 25 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Quetiapine fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5484
Application NumberNDA020639
Product Classification
M
Marketing Category
C73594
G
Generic Name
Quetiapine fumarate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2012
FDA Product Classification
INGREDIENTS (11)
QUETIAPINE FUMARATEActive
Quantity: 300 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Quetiapine fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4257
Application NumberNDA020639
Product Classification
M
Marketing Category
C73594
G
Generic Name
Quetiapine fumarate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2012
FDA Product Classification
INGREDIENTS (12)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 100 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
Quetiapine fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5581
Application NumberNDA020639
Product Classification
M
Marketing Category
C73594
G
Generic Name
Quetiapine fumarate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2012
FDA Product Classification
INGREDIENTS (12)
QUETIAPINE FUMARATEActive
Quantity: 50 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT