rosuvastatin calcium 10 mg
1 INDICATIONS AND USAGE Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Rosuvastatin tablets are an HMG Co‑A reductase inhibitor indicated for: adult patients with hypertriglyceridemia as an adjunct to diet (1.3) adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4) adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total‑C, and ApoB (1.5) Limitations of use (1.8) : Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias. 1.3 Hypertriglyceridemia Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with homozygous familial hypercholesterolemia Rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. 1.8 Limitations of Use Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.
biocon pharma inc
ROUND PINK 10 B
10 B ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets USP are supplied as: Manufacturer:Recipharm Pharmaservices Private Limited Manufacturer: Biocon Pharma Limited NDC 70377-006-11: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-006-11: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-006-12: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-006-12: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-006-13: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 500 tablets NDC 70377-006-15: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 1000 tablets NDC 70377-007-11: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-007-11: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-007-12: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-007-12: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-007-13: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 500 tablets NDC 70377-007-15: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 1000 tablets NDC 70377-008-11: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-008-11: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-008-12: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-008-12: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-008-13: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 500 tablets NDC 70377-008-15: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 1000 tablets NDC 70377-009-11: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-009-11: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-009-12: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-009-12: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-009-13: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 500 tablets NDC 70377-009-15: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Protect from moisture.
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