DrugDashboards

Cleviprex

clevipidine · CLEVIDIPINE .5 mg/mL · Emulsion · Intravenous · Chiesi USA, Inc.

NDC 10122-0610-10 · 10 CARTON in 1 CARTON / 1 VIAL, SINGLE-USE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-USE · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. A Class II recall hit this product in the past year (Chiesi USA, Inc.).

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

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%)$2.84per billing unit (1 MG)HCPCS J0759 · Jul 1, 2026
  • Federal contracts pay (FSS)$536.69per package of 10X50MLChiesi USA, 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
$907.76
Reported to Texas DSHS · 2026 annual filing · Chiesi USA

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 1 MG
$2.837
HCPCS J0759 · Jul 1, 2026 quarter · typically ASP + 6%

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
NDA022156
TE code
Approval date
Aug 1, 2008
Patents / exclusivity
9 patents, 0 exclusivities
TypeNumber / codeExpires
patent8658676Oct 10, 2031
patent11103490Oct 10, 2031
patent10010537Oct 10, 2031
patent10010537Oct 10, 2031
patent8658676Oct 10, 2031
patent10010537Oct 10, 2031
patent11103490Oct 10, 2031
patent8658676Oct 10, 2031
patent11103490Oct 10, 2031

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJul 6, 2026
    Chiesi USA, Inc.Lack of Assurance of Sterility

Manufacturers of clevipidine (Emulsion)

LabelerStrengthFirst seenLast seen
Chiesi USA, Inc.CLEVIDIPINE .5 mg/mLJul 15, 2026Sep 3, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Cleviprex — NDC 10122-0610-10," retrieved September 3, 2026, https://drugdashboards.com/drug/10122061010.

Free to cite with attribution — see how the data is put together.