Rosuvastatin
Rosuvastatin is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including Rosuvastatin, Crestor. Available dosage forms: tablet, film coated, tablet, coated, tablet, powder.
Drug Details
- Generic Name
- Rosuvastatin
- Brand Names
- Rosuvastatin, Crestor
- Application Number
- ANDA206381
- Sponsor
- ScieGen Pharmaceuticals, Inc.
- NDC Codes
- 50
- Dosage Forms
- TABLET, FILM COATED, TABLET, COATED, TABLET, POWDER
- Routes
- ORAL
- Active Ingredients
- ROSUVASTATIN, ROSUVASTATIN CALCIUM
Indications and Usage
1 INDICATIONS AND USAGE Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Rosuvastatin tablets are an HMG Co‑A reductase inhibitor (statin) indicated: (1) To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with primary hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.