bivalirudin
bivalirudin · BIVALIRUDIN 250 mg/5mL · Injection, Powder, Lyophilized, For Solution · Patheon Italia S.p.A
NDC 68225-0041-00 · 27540 VIAL in 1 CONTAINER / 5 mL in 1 VIAL · DRUG FOR FURTHER PROCESSING · View full market →
Bulk ingredient — not a finished product
This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.
Medicare Part D
This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.
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.
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
- —
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- —
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 68225-0041-00," retrieved September 3, 2026, https://drugdashboards.com/drug/68225004100.
Free to cite with attribution — see how the data is put together.