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.
Ambelvist
Gadoquatrane · GADOQUATRANE 257.9 mg/mL · Injection · Intravenous · Bayer HealthCare Pharmaceuticals Inc.
NDC 50419-0327-11 · 10 BOTTLE in 1 CARTON / 65 mL in 1 BOTTLE · NDA · 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.
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
- NDA219627
- TE code
- —
- Approval date
- Jun 12, 2026
- Patents / exclusivity
- 36 patents, 6 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NCE | Jun 12, 2031 |
| exclusivity | NCE | Jun 12, 2031 |
| exclusivity | NCE | Jun 12, 2031 |
| exclusivity | NCE | Jun 12, 2031 |
| exclusivity | NCE | Jun 12, 2031 |
| exclusivity | NCE | Jun 12, 2031 |
| patent | 11944690 | May 19, 2040 |
| patent | 11944690 | May 19, 2040 |
| patent | 11944690 | May 19, 2040 |
| patent | 11944690 | May 19, 2040 |
| patent | 11944690 | May 19, 2040 |
| patent | 11944690 | May 19, 2040 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Gadoquatrane (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Bayer AG | GADOQUATRANE 257.9 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Bayer HealthCare Pharmaceuticals Inc. | GADOQUATRANE 257.9 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, "Ambelvist — NDC 50419-0327-11," retrieved September 3, 2026, https://drugdashboards.com/drug/50419032711.
Free to cite with attribution — see how the data is put together.