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NDC 42291-0081-50 Ezetimibe and Simvastatin 10; 80 mg/1; mg/1 Details
Ezetimibe and Simvastatin 10; 80 mg/1; mg/1
Ezetimibe and Simvastatin is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is EZETIMIBE; SIMVASTATIN.
MedlinePlus Drug Summary
Ezetimibe is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of cholesterol (a fat-like substance) and other fatty substances in the blood. It may be used alone or in combination with an HMG-CoA reductase inhibitor (statin). Ezetimibe is in a class of medications called cholesterol-lowering medications. It works by preventing the absorption of cholesterol in the intestine. Buildup of cholesterol and fats along the walls of the blood vessels (a process known as atherosclerosis) decreases blood flow, which decreases the oxygen supply to the heart, brain, and other parts of the body. Lowering blood levels of cholesterol and fats may help reduce this buildup and may decrease your chances of developing heart conditions such as angina (chest pain), strokes, and heart attacks. Results of a clinical study that compared people who took ezetimibe and simvastatin with people who took simvastatin alone found that although the group of people taking ezetimibe and simvastatin had lower amounts of cholesterol in the blood, there was no difference between the two groups in the amount of cholesterol and fat buildup on the insides of the blood vessels in the neck. It is not currently understood why the additional lowering of cholesterol levels in the blood did not lead to a greater decrease in cholesterol and fat buildup along the walls of the blood vessels in people taking ezetimibe and simvastatin. Further studies are underway to compare treatment with ezetimibe and simvastatin to treatment with simvastatin alone to see if there is a difference in the risk of developing heart disease. Talk to your doctor if you have questions about the risks and benefits of treating increased amounts of cholesterol in your blood with ezetimibe and other medications. In addition to taking a cholesterol-lowering medication, making certain changes in your daily habits can also lower your blood cholesterol levels. You should eat a diet that is low in saturated fat and cholesterol (see SPECIAL DIETARY); exercise 30 minutes on most, if not all, days; and lose weight if you are overweight.
Related Packages: 42291-0081-50Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ezetimibe
Simvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Simvastatin is also used to decrease the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol (''bad cholesterol'') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol (''good cholesterol'') in the blood. Simvastatin may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Simvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with simvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.
Related Packages: 42291-0081-50Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simvastatin
Product Information
NDC | 42291-0081 |
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Product ID | 42291-081_0e8b3503-236f-af12-e063-6294a90af0c0 |
Associated GPIs | |
GCN Sequence Number | 057864 |
GCN Sequence Number Description | ezetimibe/simvastatin TABLET 10 MG-80MG ORAL |
HIC3 | M4M |
HIC3 Description | ANTIHYPERLIP.HMG COA REDUCT INHIB-CHOLEST.AB.INHIB |
GCN | 23126 |
HICL Sequence Number | 026505 |
HICL Sequence Number Description | EZETIMIBE/SIMVASTATIN |
Brand/Generic | Generic |
Proprietary Name | Ezetimibe and Simvastatin |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Ezetimibe and Simvastatin |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 10; 80 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | EZETIMIBE; SIMVASTATIN |
Labeler Name | AvKARE |
Pharmaceutical Class | Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA208831 |
Listing Certified Through | 2025-12-31 |
Package
NDC 42291-0081-50 (42291008150)
NDC Package Code | 42291-081-50 |
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Billing NDC | 42291008150 |
Package | 500 TABLET in 1 BOTTLE (42291-081-50) |
Marketing Start Date | 2022-10-04 |
NDC Exclude Flag | N |
Pricing Information | N/A |