rivaroxaban
rivaroxaban is listed in the FDA National Drug Code directory with 22 NDC codes, marketed under brand names including Xarelto, rivaroxaban, XARELTO. Available dosage forms: tablet, film coated, powder, tablet, granule, for suspension.
Drug Details
- Generic Name
- rivaroxaban
- Brand Names
- Xarelto, rivaroxaban, XARELTO
- Application Number
- NDA022406
- Sponsor
- Aphena Pharma Solutions - Tennessee, LLC
- NDC Codes
- 22
- Dosage Forms
- TABLET, FILM COATED, POWDER, TABLET, GRANULE, FOR SUSPENSION
- Routes
- ORAL
- Active Ingredients
- RIVAROXABAN
Indications and Usage
1 INDICATIONS AND USAGE Rivaroxaban tablets are a factor Xa inhibitor indicated: • to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) • to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 ) 1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease. 1.8 Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.