simvastatin tablet film coated
1 INDICATIONS AND USAGE Simvastatin tablets USP are 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 USP are an HMG-CoA reductase inhibitor 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.
Lupin Pharmaceuticals, Inc.
OVAL BROWN LL C03
LL C03 OVAL BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING
SIMVASTATIN Tablets USP, 5 mg are tan colored, round, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C01' on the other side. They are supplied as follows: NDC 68180-482-06 Bottles of 30 * NDC 68180-482-09 Bottles of 90 * NDC 68180-482-03 Bottles of 1000 *
SIMVASTATIN Tablets USP, 10 mg are peach colored, oval shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C02' on the other side. They are supplied as follows: NDC 68180-478-01 Bottles of 30 NDC 68180-478-02 Bottles of 90 NDC 68180-478-03 Bottles of 1000
SIMVASTATIN Tablets USP, 20 mg are tan colored, oval shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C03' on the other side. They are supplied as follows: NDC 68180-479-01 Bottles of 30 NDC 68180-479-02 Bottles of 90 NDC 68180-479-03 Bottles of 1000
SIMVASTATIN Tablets USP, 40 mg are brick red colored, round shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C04' on the other side. They are supplied as follows: NDC 68180-464-06 Bottles of 30 NDC 68180-464-09 Bottles of 90 NDC 68180-464-03 Bottles of 1000
SIMVASTATIN Tablets USP, 80 mg are brick red colored, capsule shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C05' on the other side. They are supplied as follows: NDC 68180-465-06 Bottles of 30 NDC 68180-465-09 Bottles of 90 NDC 68180-465-03 Bottles of 1000 *The 5 mg strength of
SIMVASTATIN Tablets USP is no longer being marketed. Storage Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preserve in tight container as defined in USP.
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