The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Iodixanol
Iodixanol · IODIXANOL 270 mg/mL · Injection, Solution · Intravascular · Fresenius Kabi Usa, Llc
NDC 65219-0381-10 · 10 BOTTLE, PLASTIC in 1 BOX / 100 mL in 1 BOTTLE, PLASTIC · ANDA · View full market →
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
$817.00
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 1 ML
$0.435
HCPCS Q9966 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2025)
$49
263 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
- ANDA214271
- TE code
- AP
- Approval date
- May 19, 2022
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Iodixanol (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| GE Healthcare Inc. | IODIXANOL 320 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Fresenius Kabi Usa, Llc | IODIXANOL 270 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Fresenius Kabi Usa, Llc | IODIXANOL 320 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| GE Healthcare Inc. | IODIXANOL 270 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Iodixanol — NDC 65219-0381-10," retrieved September 3, 2026, https://drugdashboards.com/drug/65219038110.
Free to cite with attribution — see how the data is put together.