Quick answers
- What is Xenon xe 129 hyperpolarized (helium / nitrogen / xenon xe-129) used for?
- The FDA-approved label (Xenoview, Polarean, Inc., May 30, 2025) says: “XENOVIEW ®, prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Xenon xe 129 hyperpolarized (helium / nitrogen / xenon xe-129) have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Xenon xe 129 hyperpolarized (helium / nitrogen / xenon xe-129)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Xenon xe 129 hyperpolarized (helium / nitrogen / xenon xe-129) been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Xenon xe 129 hyperpolarized (helium / nitrogen / xenon xe-129)?
- 1 company lists prescription products of Xenon xe 129 hyperpolarized (helium / nitrogen / xenon xe-129) in the FDA NDC Directory, including Polarean, Inc..
What Xenon xe 129 hyperpolarized (helium / nitrogen / xenon xe-129) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
XENOVIEW ®, prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. …
— FDA label: Xenoview, Polarean, Inc., effective May 30, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Gas |
|---|---|
| Route | Respiratory (inhalation) |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Xenoview |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Polarean, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA214375 XENOVIEW | Polarean | December 23, 2022 | 1, latest May 30, 2025 2025: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 70e33fe3-c722-439b-b3db-c2a22f229c8a |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA214375 |
| Active ingredients (FDA) | HELIUM / NITROGEN / XENON XE-129 |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xenoview, Polarean, Inc., effective May 30, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →