Ezetimibe and Simvastatin
These highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE and SIMVASTATIN tablets, for oral useInitial U.S. Approval: 2004
Approved
Approval ID
5ea3ca31-cfee-4978-8b7a-755986f6b091
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 4, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code69238-1156
Application NumberANDA208831
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe and Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2023
FDA Product Classification
INGREDIENTS (10)
SIMVASTATINActive
Quantity: 20 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Ezetimibe and Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1155
Application NumberANDA208831
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe and Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2023
FDA Product Classification
INGREDIENTS (10)
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
SIMVASTATINActive
Quantity: 10 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
Ezetimibe and Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1158
Application NumberANDA208831
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe and Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2023
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
SIMVASTATINActive
Quantity: 80 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Ezetimibe and Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1157
Application NumberANDA208831
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe and Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2023
FDA Product Classification
INGREDIENTS (10)
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
SIMVASTATINActive
Quantity: 40 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT