On this page
Xenon, Xe-133
Xenon · Gas
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Inhalation Diagnostic Agent [EPC] | EPC | 2 members — no class page |
| Radiopharmaceutical Activity [MoA] | MoA | All 17 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 018327-001 | XENON XE 133 | GAS | XENON XE-133 | Prescription | — | ||
| 018327-002 | XENON XE 133 | GAS | XENON XE-133 | Prescription | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 5 | Manufacturing (CMC) | Approved | March 9, 2016 | Standard |
| Supplement | 3 | Manufacturing (CMC) | Approved | September 19, 1997 | Standard |
| Supplement | 1 | Manufacturing (CMC) | Approved | May 26, 1988 | Standard |
| Original application | 1 | Type 5 - New Formulation or New Manufacturer | Approved | March 9, 1982 | Standard |
Review documents
- 0 · Supplement · March 14, 2016
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241016). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Xenon Xe 133 Gas is administered by inhalation from a closed respirator system or spirometer. The final patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. The recommended activity range employed for inhalation by the average patient (70 kg) is: Pulmonary function including imaging: 74 to 1110 megabecquerels (2 to 30 millicuries) Cerebral blood flow: 370 to 1110 megabecquerels (10 to 30 millicuries) This may be administered as a bolus into the tubing near the patient's mouthpiece or mask after the completion of a tidal exhalation, or by rebreathing for a period of approximately 5 minutes of the Xenon Xe 133 gas in equilibrium with the air contained in the closed system at concentrations of the radionuclide that may vary from 37 to 222 megabecquerels (1.0 to 6.0 millicuries) per liter.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS None known.
Warnings
openFDA Drug LabelingWARNINGS Xenon Xe 133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leakproof to avoid loss of radioactivity into the laboratory environs not specifically protected by exhaust systems. Xenon Xe 133 Gas adheres to some plastics and rubber and should not be allowed to stand in tubing or respirator containers. Loss of radioactivity due to such adherence may render the study nondiagnostic.
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS Adverse reactions specifically attributable to Xenon Xe 133 Gas have not been reported.
Description
openFDA Drug LabelingDESCRIPTION Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition Percent of Total Radioactivity Days % Xe-133 % Xe-133m % Xe-131m % Kr-85 % I-131 -5 >98.3 98.1 97.2 95.7 <0.02 <4.1 <0.37 <0.02
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Xenon Xe 133 Gas is available in 2 milliliter vials with color-coded labels in 370 megabecquerel (10 millicurie; Catalog No. 097) and 740 megabecquerel (20 millicurie; Catalog No. 098) sizes. Both sizes are available in packages of 1, 3 and 5 vials, each with individual lead shielding.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: XENON XE-133. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 69945-097-11 | 69945-097 | Curium US LLC | 1 CAN in 1 CONTAINER (69945-097-11) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE | March 30, 2016 |
| 69945-097-13 | 69945-097 | Curium US LLC | 3 CAN in 1 CONTAINER (69945-097-13) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE | March 30, 2016 |
| 69945-097-15 | 69945-097 | Curium US LLC | 5 CAN in 1 CONTAINER (69945-097-15) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE | March 30, 2016 |
| 69945-098-21 | 69945-098 | Curium US LLC | 1 CAN in 1 CONTAINER (69945-098-21) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE | March 30, 2016 |
| 69945-098-23 | 69945-098 | Curium US LLC | 3 CAN in 1 CONTAINER (69945-098-23) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE | March 30, 2016 |
| 69945-098-25 | 69945-098 | Curium US LLC | 5 CAN in 1 CONTAINER (69945-098-25) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE | March 30, 2016 |
| 69945-097 | 69945-097 | Curium US LLC | — | March 30, 2016 |
| 69945-098 | 69945-098 | Curium US LLC | — | March 30, 2016 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.