The short version
11 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Bivalirudin
Bivalirudin · BIVALIRUDIN 250 mg/1 · Injection, Powder, Lyophilized, For Solution · Intravenous · Hainan Shuangcheng Pharmaceuticals Co., Ltd.
NDC 52958-0034-01 · 10 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- analysis · api manufacture · label · manufacture · pack · sterilize
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA210031
- TE code
- AP
- Approval date
- Oct 23, 2019
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Bivalirudin (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Avenacy, LLC | BIVALIRUDIN 250 mg/1 | Sep 3, 2026 | Sep 3, 2026 |
| Accord Healthcare, Inc. | BIVALIRUDIN 250 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Avenacy, Inc. | BIVALIRUDIN 250 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Civica, Inc. | BIVALIRUDIN 250 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Eugia US LLC | BIVALIRUDIN 250 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Hainan Shuangcheng Pharmaceuticals Co., Ltd. | BIVALIRUDIN 250 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Institutional LLC | BIVALIRUDIN 250 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Patheon Italia S.p.A | BIVALIRUDIN 250 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Sandoz Inc | BIVALIRUDIN 250 mg/1 | Jul 29, 2026 | Sep 2, 2026 |
| Meitheal Pharmaceuticals Inc. | BIVALIRUDIN 250 mg/5mL | Jul 15, 2026 | Aug 31, 2026 |
| Fresenius Kabi USA, LLC | BIVALIRUDIN 250 mg/1 | Jul 15, 2026 | Aug 28, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Bivalirudin — NDC 52958-0034-01," retrieved September 3, 2026, https://drugdashboards.com/drug/52958003401.
Free to cite with attribution — see how the data is put together.