Simvastatin 10 MG Oral Tablet
1 INDICATIONS AND USAGE Simvastatin tablets 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 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.
aurobindo pharma limited
ROUND PINK A 01
A 01 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING
SIMVASTATIN Tablets USP, 5 mg are yellow colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘15’ on the other side. They are supplied as follows: Bottles of 30 NDC 65862-050-30 (Child Resistant Closure) Bottles of 45 NDC 65862-050-45 (Child Resistant Closure) Bottles of 90 NDC 65862-050-90 (Child Resistant Closure) Bottles of 100 NDC 65862-050-01 (Child Resistant Closure) Bottles of 100 NDC 65862-050-00 (Non-Child Resistant Closure) Bottles of 1,000 NDC 65862-050-99 (Non-Child Resistant Closure) Bottles of 2,500 NDC 65862-050-26 (Non-Child Resistant Closure)
SIMVASTATIN Tablets USP, 10 mg are light pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘01’ on the other side. They are supplied as follows: Bottles of 30 NDC 65862-051-30 (Child Resistant Closure) Bottles of 45 NDC 65862-051-45 (Child Resistant Closure) Bottles of 90 NDC 65862-051-90 (Child Resistant Closure) Bottles of 100 NDC 65862-051-01 (Child Resistant Closure) Bottles of 100 NDC 65862-051-00 (Non-Child Resistant Closure) Bottles of 1,000 NDC 65862-051-99 (Non-Child Resistant Closure) Bottles of 2,500 NDC 65862-051-26 (Non-Child Resistant Closure)
SIMVASTATIN Tablets USP, 20 mg are light pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘02’ on the other side. They are supplied as follows: Bottles of 30 NDC 65862-052-30 (Child Resistant Closure) Bottles of 45 NDC 65862-052-45 (Child Resistant Closure) Bottles of 90 NDC 65862-052-90 (Child Resistant Closure) Bottles of 100 NDC 65862-052-01 (Child Resistant Closure) Bottles of 100 NDC 65862-052-00 (Non-Child Resistant Closure) Bottles of 1,000 NDC 65862-052-99 (Non-Child Resistant Closure) Bottles of 2,500 NDC 65862-052-26 (Non-Child Resistant Closure)
SIMVASTATIN Tablets USP, 40 mg are pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘03’ on the other side. They are supplied as follows: Bottles of 30 NDC 65862-053-30 (Child Resistant Closure) Bottles of 45 NDC 65862-053-45 (Child Resistant Closure) Bottles of 90 NDC 65862-053-90 (Child Resistant Closure) Bottles of 100 NDC 65862-053-01 (Child Resistant Closure) Bottles of 100 NDC 65862-053-00 (Non-Child Resistant Closure) Bottles of 1,000 NDC 65862-053-99 (Non-Child Resistant Closure) Bottles of 2,000 NDC 65862-053-22 (Non-Child Resistant Closure)
SIMVASTATIN Tablets USP, 80 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘04’ on the other side. They are supplied as follows: Bottles of 30 NDC 65862-054-30 (Child Resistant Closure) Bottles of 45 NDC 65862-054-45 (Child Resistant Closure) Bottles of 90 NDC 65862-054-90 (Child Resistant Closure) Bottles of 100 NDC 65862-054-00 (Non-Child Resistant Closure) Bottles of 1,000 NDC 65862-054-99 (Non-Child Resistant Closure) Bottles of 3,000 NDC 65862-054-39 (Non-Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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