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Rx only · Injection, Powder, Lyophilized, For Solution · Intravenous

Bivalirudin

Bivalirudin

8 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US8 NDCs
8 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
RxCUI (US)60819
US makers8 labelers
Packages10
DEA / ScheduleNone

Medicaid dispensing volumeSDUD · per quarter

Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.

35701051402025 Q12025 Q22025 Q32025 Q42026 Q1
122
Rx · 2026 Q1
877
Units dispensed
+16%
Rx vs. year ago
5
Quarters · since 2025 Q1

Who makes it8 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Meitheal Pharmaceuticals Inc.unknown2SUPPLYING
Fresenius Kabi USA, LLCunknown2SUPPLYING
Avenacy, LLCunknown1SUPPLYING
Accord Healthcare Inc.unknown1SUPPLYING
Eugia US LLCunknown1SUPPLYING
Mylan Institutional LLCunknown1SUPPLYING
Hainan Shuangcheng Pharmaceuticals Co., Ltd.unknown1SUPPLYING
Civica, Inc.unknown1SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Jul 3, 2023
    RECALLRecall (Class II): Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 2…

    Presence of Particulate Matter: Particulate matter identified as fiber. — Recalling firm: Accord Healthcare, Inc. — Nationwide within the United States