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/5mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Accord Healthcare, Inc.
NDC 16729-0275-67 · 10 VIAL, SINGLE-USE in 1 CARTON / 5 mL 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.
Estimated fill cost
WAC per package, as filed
$715.85
Reported to Texas DSHS · 2026 annual filing · Accord Healthcare, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 1 MG
$0.166
HCPCS J0583 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2024)
$732
11 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- analysis · manufacture
- analysis · manufacture
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
- ANDA206551
- TE code
- AP
- Approval date
- Nov 22, 2017
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · TerminatedJul 3, 2023Accord Healthcare, Inc. — Presence of Particulate Matter: Particulate matter identified as fiber.
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 16729-0275-67," retrieved September 3, 2026, https://drugdashboards.com/drug/16729027567.
Free to cite with attribution — see how the data is put together.