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Xenon, Xe-133

Xenon · Gas

Prescription NDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Xenon, Xe-133
Generic name
Xenon
Dosage form
Gas
Route
Respiratory (Inhalation)
Marketing category
NDA · NDA
Labeler
Curium US LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
6
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Xenon Xe-133 10 mCi/mL — View
Xenon Xe-133 5 mCi/mL — View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Gas
Route of administration
Respiratory (Inhalation)
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Application number
018327
Application type
NDA · New Drug Application
Approval date
March 9, 1982
Sponsor
CURIUM
Products on application
2
Submissions recorded
4
Products approved under application 018327.
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
Most recent submissions on application 018327.
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 Labeling

Reproduced 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.

HUMAN PRESCRIPTION DRUG · 20241016

Indications and Usage

openFDA Drug Labeling

INDICATIONS 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 Labeling

DOSAGE 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 Labeling

CONTRAINDICATIONS None known.

WARNINGS 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 Labeling

ADVERSE REACTIONS Adverse reactions specifically attributable to Xenon Xe 133 Gas have not been reported.

Description

openFDA Drug Labeling

DESCRIPTION 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 Labeling

HOW 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 FAERS
13
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.