Simcor
These highlights do not include all the information needed to use SIMCOR safely and effectively. See full prescribing information for SIMCOR. SIMCOR (simvastatin/niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 2008
Approved
Approval ID
dd749fb9-e279-4958-9534-ad75a5b6754b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2010
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.
simvastatin and niacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5907
Application NumberNDA022078
Product Classification
M
Marketing Category
C73594
G
Generic Name
simvastatin and niacin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (12)
NIACINActive
Quantity: 750 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
SIMVASTATINActive
Quantity: 20 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
simvastatin and niacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6169
Application NumberNDA022078
Product Classification
M
Marketing Category
C73594
G
Generic Name
simvastatin and niacin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (11)
SIMVASTATINActive
Quantity: 40 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
NIACINActive
Quantity: 1000 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
simvastatin and niacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5904
Application NumberNDA022078
Product Classification
M
Marketing Category
C73594
G
Generic Name
simvastatin and niacin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (12)
SIMVASTATINActive
Quantity: 20 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
NIACINActive
Quantity: 1000 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
simvastatin and niacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5886
Application NumberNDA022078
Product Classification
M
Marketing Category
C73594
G
Generic Name
simvastatin and niacin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (12)
NIACINActive
Quantity: 500 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SIMVASTATINActive
Quantity: 20 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT