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
3dc79540-2f24-4920-99cd-ef6482f68eb2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-119
Application NumberNDA020639
Product Classification
M
Marketing Category
C73594
G
Generic Name
Quetiapine fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2010
FDA Product Classification
INGREDIENTS (12)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 100 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOLInactive
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 Code21695-120
Application NumberNDA020639
Product Classification
M
Marketing Category
C73594
G
Generic Name
Quetiapine fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2010
FDA Product Classification
INGREDIENTS (11)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 200 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIB
Quetiapine fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-117
Application NumberNDA020639
Product Classification
M
Marketing Category
C73594
G
Generic Name
Quetiapine fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2010
FDA Product Classification
INGREDIENTS (13)
QUETIAPINE FUMARATEActive
Quantity: 25 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Quetiapine fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-118
Application NumberNDA020639
Product Classification
M
Marketing Category
C73594
G
Generic Name
Quetiapine fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2010
FDA Product Classification
INGREDIENTS (12)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
QUETIAPINE FUMARATEActive
Quantity: 50 mg in 1 1
Code: 2S3PL1B6UJ
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT