DrugDashboards

Optiray 300

Ioversol · IOVERSOL 636 mg/mL · Injection · Intra-Arterial; Intravenous · Liebel-Flarsheim Company LLC

NDC 00019-1332-00 · 20 SYRINGE, PLASTIC in 1 CARTON / 100 mL in 1 SYRINGE, PLASTIC · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, Liebel-Flarsheim Company LLC, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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
$868.00
Reported to Texas DSHS · 2025 annual filing · Liebel Flarsheim

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

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
NDA019710
TE code
Approval date
Dec 30, 1988
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedSep 13, 2019
    GUERBET LLCLabeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.

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 300 — NDC 00019-1332-00," retrieved September 3, 2026, https://drugdashboards.com/drug/00019133200.

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