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Bivalirudin

NDC 63323-562 · Fresenius Kabi USA, LLC

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/1
Pharmacologic classAnti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
Marketing categoryANDA

Packages

63323-562-10 — 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

63323-562-15 — 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41)

Billed under HCPCS

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

Related Codes

Same active ingredient

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, 67457-256 — bivalirudin, 70436-025 — bivalirudin, 70511-142 — Bivalirudin, 71288-427 — BIVALIRUDIN, 72572-035 — bivalirudin, 83634-400 — bivalirudin

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