The short version
Only one company currently supplies this market — there is no backup if it stumbles.
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Xenoview
xenon Xe 129 hyperpolarized · XENON XE-129, HYPERPOLARIZED 75 mL/L · Gas · Respiratory (Inhalation) · Polarean, Inc.
NDC 80534-1000-01 · 50 BAG in 1 CARTON / 1 L in 1 BAG · 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.
Regulatory
- Application
- NDA214375
- TE code
- —
- Approval date
- Dec 23, 2022
- Patents / exclusivity
- 2 patents, 1 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NCE | Dec 23, 2027 |
| patent | 11052161 | Dec 29, 2035 |
| patent | 10583205 | Feb 20, 2035 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of xenon Xe 129 hyperpolarized (Gas)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Polarean, Inc. | XENON XE-129, HYPERPOLARIZED 75 mL/300mL | Jul 15, 2026 | Sep 2, 2026 |
| Polarean, Inc. | XENON XE-129, HYPERPOLARIZED 75 mL/750mL | Jul 15, 2026 | Sep 2, 2026 |
| Polarean, Inc. | XENON XE-129, HYPERPOLARIZED 75 mL/L | Jul 15, 2026 | Sep 2, 2026 |
| Polarean, Inc. | XENON XE-129 63.5 L/1; NITROGEN 635 L/1; HELIUM 5651.5 L/1 | Aug 26, 2026 | Sep 2, 2026 |
| Polarean, Inc. | XENON XE-129, HYPERPOLARIZED 75 mL/500mL | Jul 15, 2026 | Sep 2, 2026 |
| Polarean, Inc. | XENON XE-129 5651.5 L/1; NITROGEN 635 L/1; HELIUM 63.5 L/1 | Jul 22, 2026 | Aug 19, 2026 |
| Polarean, Inc. | HELIUM 5651.5 L/1; NITROGEN 635 L/1; XENON XE-129 63.5 L/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Xenoview — NDC 80534-1000-01," retrieved September 3, 2026, https://drugdashboards.com/drug/80534100001.
Free to cite with attribution — see how the data is put together.