Rx only · Injection, Powder, Lyophilized, For Solution · Intravenous
Bivalirudin
Bivalirudin
8 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US8 NDCs
8 active makers
8 active makers
UKComing
soon
soon
CAComing
soon
soon
AUComing
soon
soon
EUComing
soon
soon
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.
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.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Meitheal Pharmaceuticals Inc. | unknown | 2 | SUPPLYING |
| Fresenius Kabi USA, LLC | unknown | 2 | SUPPLYING |
| Avenacy, LLC | unknown | 1 | SUPPLYING |
| Accord Healthcare Inc. | unknown | 1 | SUPPLYING |
| Eugia US LLC | unknown | 1 | SUPPLYING |
| Mylan Institutional LLC | unknown | 1 | SUPPLYING |
| Hainan Shuangcheng Pharmaceuticals Co., Ltd. | unknown | 1 | SUPPLYING |
| Civica, Inc. | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jul 3, 2023RECALLRecall (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
Pill