simvastatin
Simvastatin Tablets USP. These highlights do not include all the information needed to use SIMVASTATIN . See full prescribing information for SIMVASTATIN. Initial U.S. Approval 2007
Approved
Approval ID
7e3fc83f-e322-44a1-b0c3-30e6292b92d9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2017
Manufacturers
FDA
DOH CENTRAL PHARMACY
DUNS: 829348114
Products 3
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 Code53808-0791
Application NumberANDA078103
Product Classification
M
Marketing Category
C73584
G
Generic Name
SIMVASTATIN
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2017
FDA Product Classification
INGREDIENTS (15)
SIMVASTATINActive
Quantity: 20 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SIMVASTATIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0794
Application NumberANDA078103
Product Classification
M
Marketing Category
C73584
G
Generic Name
SIMVASTATIN
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2017
FDA Product Classification
INGREDIENTS (14)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SIMVASTATINActive
Quantity: 40 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SIMVASTATIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0790
Application NumberANDA078103
Product Classification
M
Marketing Category
C73584
G
Generic Name
SIMVASTATIN
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2017
FDA Product Classification
INGREDIENTS (14)
SIMVASTATINActive
Quantity: 10 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT