bivalirudin

FDA Drug Profile — bivalirudin, Bivalirudin

bivalirudin is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including bivalirudin, Bivalirudin. Available dosage forms: injection, powder, lyophilized, for solution, injection, powder, lyophilized, for suspension, powder.

Drug Details

Generic Name
bivalirudin
Brand Names
bivalirudin, Bivalirudin
Application Number
NDA020873
Sponsor
Civica, Inc.
NDC Codes
9
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, POWDER
Routes
INTRAVENOUS
Active Ingredients
BIVALIRUDIN

Indications and Usage

1 INDICATIONS AND USAGE Bivalirudin for Injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Bivalirudin for Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS). ( 1 )