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, powder, injection, powder, lyophilized, for suspension.

Drug Details

Generic Name
bivalirudin
Brand Names
Bivalirudin, bivalirudin
Application Number
ANDA206551
Sponsor
Accord Healthcare, Inc.
NDC Codes
9
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER, INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
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 )