BIVALIRUDIN

NDC 71288-427 · Meitheal Pharmaceuticals Inc.

FDA carries 2 listing records for this NDC; the most recent is shown.

Generic nameBIVALIRUDIN

Dosage formINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

RouteINTRAVENOUS

Active ingredient(s)BIVALIRUDIN

Strength250 mg/5mL

Pharmacologic classAnti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]

Marketing categoryANDA

Packages

71288-427-11 — 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-10)

71288-427-92 — 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-92) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-91)

J0583 — Injection, bivalirudin, 1 mg Medicare Part B payment limit (ASP + 6%): $0.17

FDA lists these products with the same active ingredient.

0781-3158 — bivalirudin, 16729-275 — bivalirudin, 42023-622 — Bivalirudin, 52958-034 — Bivalirudin, 55111-652 — Bivalirudin, 55150-210 — BIVALIRUDIN, 63323-562 — Bivalirudin, 67457-256 — bivalirudin, 70436-025 — bivalirudin, 70511-142 — Bivalirudin, 72572-035 — bivalirudin, 83634-400 — bivalirudin

From the FDA National Drug Code Directory, retrieved 2026-08-24. Product listings are submitted by labelers; FDA does not verify them.