clopidogrel
clopidogrel is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including Plavix, clopidogrel, Clopidogrel. Available dosage forms: tablet, film coated, tablet.
Drug Details
- Generic Name
- clopidogrel
- Brand Names
- Plavix, clopidogrel, Clopidogrel
- Application Number
- NDA020839
- Sponsor
- Sanofi-Aventis U.S. LLC
- NDC Codes
- 5
- Dosage Forms
- TABLET, FILM COATED, TABLET
- Routes
- ORAL
- Active Ingredients
- CLOPIDOGREL BISULFATE
Indications and Usage
1 INDICATIONS AND USAGE Clopidogrel tablets are a P2Y 12 platelet inhibitor indicated for: Acute coronary syndrome - For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. ( 1.1 ) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. ( 1.2) 1.1 Acute Coronary Syndrome (ACS) Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin. Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin. 1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke.