Ezetimibe and Simvastatin
EZETIMIBE AND SIMVASTATIN TABLETS These highlights do not include all the information needed to use TABLETS safely and effectively. See full prescribing information for . EZETIMIBE AND SIMVASTATIN tablets for oral use Initial U.S. Approval: 2004
Approved
Approval ID
88cd0e7b-e8dc-6125-e053-2a95a90aaa27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Golden State Medical Supply
DUNS: 603184490
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ezetimibe and Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-190
Application NumberANDA200909
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe and Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
SIMVASTATINActive
Quantity: 10 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
Ezetimibe and Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-193
Application NumberANDA200909
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe and Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (10)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SIMVASTATINActive
Quantity: 80 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
Ezetimibe and Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-192
Application NumberANDA200909
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe and Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (10)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
SIMVASTATINActive
Quantity: 40 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
Ezetimibe and Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-191
Application NumberANDA200909
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe and Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
SIMVASTATINActive
Quantity: 20 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB