Simvastatin
These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets, USP Initial U.S. Approval: 1991
Approved
Approval ID
84e3af60-8814-49f6-918e-a4e1c702aa05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2010
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
Products 1
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 Code66116-408
Application NumberANDA077691
Product Classification
M
Marketing Category
C73584
G
Generic Name
Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2010
FDA Product Classification
INGREDIENTS (14)
SIMVASTATINActive
Quantity: 40 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT