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 · Sandoz Inc
NDC 00781-3158-95 · 10 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE · NDA AUTHORIZED GENERIC · View full market →
One drug, every price
The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.
ⓘ How this was built
Data sources
- CMS NADAC (pharmacy acquisition, weekly)
- CMS Part B ASP quarterly payment limits
- CMS Maximum Fair Prices (IRA negotiated, NDC-level)
- Medicare Part D Spending by Drug (data.cms.gov, name-matched)
- VA FSS / Big4 federal contract prices (va.gov, twice monthly)
- ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
- California SB-17 WAC filings (list price, per package)
Method
Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
- Medicare Part B pays (ASP+6%)$0.1660per billing unit (1 MG)HCPCS J0583 · Jul 1, 2026
- Federal contracts pay (FSS)$9.74per unitSandoz, Inc. · Jan 1, 2026
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
$750.00
Reported to Texas DSHS · 2026 annual filing · Sandoz
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)
$12,131
93 prescriptions paid by Medicaid nationally · all Medicaid spend →
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
- NDA020873
- TE code
- AP
- Approval date
- Dec 15, 2000
- Patents / exclusivity
- 4 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 7582727*PED | Jan 27, 2029 |
| patent | 7598343*PED | Jan 27, 2029 |
| patent | 7582727 | Jul 27, 2028 |
| patent | 7598343 | Jul 27, 2028 |
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 00781-3158-95," retrieved September 3, 2026, https://drugdashboards.com/drug/00781315895.
Free to cite with attribution — see how the data is put together.