The short version
Just 3 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.
gadoterate meglumine
gadoterate meglumine · GADOTERATE MEGLUMINE 376.9 mg/mL · Injection · Intravenous · Slate Run Pharmaceuticals, LLC
NDC 70436-0123-34 · 10 VIAL in 1 CARTON / 15 mL in 1 VIAL · 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
$70.83
Reported to Texas DSHS · 2025 annual filing · Slate Run Pharmaceuticals, LLC.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 0.1 ML
$0.090
HCPCS A9575 · Jul 1, 2026 quarter · typically ASP + 6%
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- api manufacture
- manufacture
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
- ANDA218073
- TE code
- AP
- Approval date
- Jun 17, 2024
- Patents / exclusivity
- None on file
Shortage history
- Planned discontinuation — Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-080-05)May 21, 2026
- Planned discontinuation — Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-082-10)May 21, 2026
- Planned discontinuation — Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-084-15)May 21, 2026
- Planned discontinuation — Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-086-20)May 21, 2026
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of gadoterate meglumine (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Fresenius Kabi USA, LLC | GADOTERATE MEGLUMINE 376.9 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Guerbet LLC | GADOTERATE MEGLUMINE 376.9 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Slate Run Pharmaceuticals, LLC | GADOTERATE MEGLUMINE 376.9 mg/mL | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "gadoterate meglumine — NDC 70436-0123-34," retrieved September 3, 2026, https://drugdashboards.com/drug/70436012334.
Free to cite with attribution — see how the data is put together.