DrugDashboards

Optiray 350

Ioversol · IOVERSOL 741 mg/mL · Injection · Intra-Arterial; Intravenous · Liebel-Flarsheim Company LLC

NDC 00019-1333-65 · 6 BOTTLE, GLASS in 1 CARTON / 500 mL in 1 BOTTLE, GLASS · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. A Class I recall hit this product in the past year (Liebel-Flarsheim Company LLC). One of its named manufacturing plants, Liebel-Flarsheim Company LLC, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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%)$0.1550per billing unit (1 ML)HCPCS Q9967 · Jul 1, 2026
  • Federal contracts pay (FSS)$472.59per package of 500MLGuerbet L.L.C. · 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
$990.00
Reported to Texas DSHS · 2025 annual filing · Liebel Flarsheim

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

Medicare Part B (ASP)

Payment limit per 1 ML
$0.155
HCPCS Q9967 · Jul 1, 2026 quarter · typically ASP + 6%

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Where it's made

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
NDA020923
TE code
—
Approval date
May 28, 1998
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class I · OngoingJul 31, 2026
    Liebel-Flarsheim Company LLC — Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Manufacturers of Ioversol (Injection)

LabelerStrengthFirst seenLast seen
Liebel-Flarsheim Company LLCIOVERSOL 678 mg/mLJul 15, 2026Sep 3, 2026
Liebel-Flarsheim Company LLCIOVERSOL 741 mg/mLJul 15, 2026Sep 3, 2026
Liebel-Flarsheim Company LLCIOVERSOL 636 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Optiray 350 — NDC 00019-1333-65," retrieved September 3, 2026, https://drugdashboards.com/drug/00019133365.

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