Simvastatin 10 MG Oral Tablet
1 INDICATIONS AND USAGE Simvastatin is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Simvastatin tablets are an HMG-CoA reductase inhibitor indicated: ( 1 ) To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.
Zydus Pharmaceuticals (USA) Inc.
OVAL PINK ZA20
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Zydus Pharmaceuticals (USA) Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
SIMVASTATIN Tablets USP, 5 mg are white, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA19" on one side and plain on other side and are supplied as follows. NDC 68382-065-06 in bottle of 30 tablets with child-resistant closure NDC 68382-065-14 in bottle of 60 tablets with child-resistant closure NDC 68382-065-16 in bottle of 90 tablets with child-resistant closure NDC 68382-065-05 in bottle of 500 tablets NDC 68382-065-10 in bottle of 1,000 tablets
SIMVASTATIN Tablets USP, 10 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA20" on one side and plain on other side and are supplied as follows. NDC 68382-066-06 in bottle of 30 tablets with child-resistant closure NDC 68382-066-14 in bottle of 60 tablets with child-resistant closure NDC 68382-066-16 in bottle of 90 tablets with child-resistant closure NDC 68382-066-05 in bottle of 500 tablets NDC 68382-066-10 in bottle of 1,000 tablets NDC 68382-066-24 in bottle of 10,000 tablets
SIMVASTATIN Tablets USP, 20 mg are peach, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA21" on one side and plain on other side and are supplied as follows. NDC 68382-067-06 in bottle of 30 tablets with child-resistant closure NDC 68382-067-14 in bottle of 60 tablets with child-resistant closure NDC 68382-067-16 in bottle of 90 tablets with child-resistant closure NDC 68382-067-05 in bottle of 500 tablets NDC 68382-067-10 in bottle of 1,000 tablets NDC 68382-067-24 in bottle of 10,000 tablets
SIMVASTATIN Tablets USP, 40 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA22" on one side and plain on other side and are supplied as follows. NDC 68382-068-06 in bottle of 30 tablets with child-resistant closure NDC 68382-068-14 in bottle of 60 tablets with child-resistant closure NDC 68382-068-16 in bottle of 90 tablets with child-resistant closure NDC 68382-068-05 in bottle of 500 tablets NDC 68382-068-10 in bottle of 1,000 tablets NDC 68382-068-40 in bottle of 5,000 tablets
SIMVASTATIN Tablets USP, 80 mg are white to off-white, capsule shaped, biconvex, film-coated tablets debossed with "ZA23" on one side and plain on other side and are supplied as follows. NDC 68382-069-06 in bottle of 30 tablets with child-resistant closure NDC 68382-069-14 in bottle of 60 tablets with child-resistant closure NDC 68382-069-16 in bottle of 90 tablets with child-resistant closure NDC 68382-069-05 in bottle of 500 tablets NDC 68382-069-10 in bottle of 1,000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.
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