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
52a46269-2262-4052-a3ff-5455523f591f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2020
Manufacturers
FDA
NORTHSTAR RX LLC
DUNS: 830546433
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 Code16714-780
Application NumberANDA208699
Product Classification
M
Marketing Category
C73584
G
Generic Name
ezetimibe and simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2020
FDA Product Classification
INGREDIENTS (11)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
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
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
propyl gallateInactive
Code: 8D4SNN7V92
Classification: IACT
ezetimibe and simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-778
Application NumberANDA208699
Product Classification
M
Marketing Category
C73584
G
Generic Name
ezetimibe and simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2020
FDA Product Classification
INGREDIENTS (11)
simvastatinActive
Quantity: 10 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
ezetimibeActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
butylated hydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
propyl gallateInactive
Code: 8D4SNN7V92
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ezetimibe and simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-781
Application NumberANDA208699
Product Classification
M
Marketing Category
C73584
G
Generic Name
ezetimibe and simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2020
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
propyl gallateInactive
Code: 8D4SNN7V92
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ezetimibe and simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-779
Application NumberANDA208699
Product Classification
M
Marketing Category
C73584
G
Generic Name
ezetimibe and simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2020
FDA Product Classification
INGREDIENTS (11)
simvastatinActive
Quantity: 20 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
ezetimibeActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
butylated hydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
propyl gallateInactive
Code: 8D4SNN7V92
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT