Simvastatin
These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN TABLETS USP Initial U.S. Approval: 1991
Approved
Approval ID
13c80d46-429e-4007-8f89-eed2ed96eccf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 17, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-674
Application NumberANDA077752
Product Classification
M
Marketing Category
C73584
G
Generic Name
Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2010
FDA Product Classification
INGREDIENTS (15)
SimvastatinActive
Quantity: 40 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIM
ascorbic acidInactive
Code: PQ6CK8PD0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-671
Application NumberANDA077752
Product Classification
M
Marketing Category
C73584
G
Generic Name
Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2010
FDA Product Classification
INGREDIENTS (15)
ascorbic acidInactive
Code: PQ6CK8PD0R
Classification: IACT
SimvastatinActive
Quantity: 20 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIM
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT