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Xenon, Xe-133 5 mCi/mL Gas — NDC 69945-0097-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Xenon, Xe-133 5 mCi/mL Gas — NDC 69945-097-11 (Billing 69945-0097-11)

by Curium US LLC · 1 CAN in 1 CONTAINER / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE

This is a package of Xenon, Xe-133 5 mCi/mL Gas from Curium US LLC, marketed since Mar 2016 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 69945-0097-11
🏷️ FDA NDC (as labeled) 69945-097-11 billing pads the product segment with a zero
This package
Contains2 mL in 1 bottle Pack sizes3 compare ↓
Main listing for product 69945-097 · Also comes in: 3 cans 69945-097-13 5 cans 69945-097-15
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 69945-097-11 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69945 labeler · 097 product · 11 package
Package marketed since
Mar 30, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6994509711 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69945-097-11
Product NDC 69945-097
11-digit billing NDC 69945009711
UNII X3P9A5HNYF
Application # NDA018327
SPL Set ID 5eb971be-8808-4aeb-9898-0d22d5dffe04
Established class (EPC) Inhalation Diagnostic Agent
Mechanism of action Radiopharmaceutical Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-03-30
Route RESPIRATORY (INHALATION)
Dosage form GAS
Substance XENON XE-133

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 083724
GCN 52766
HICL code 048216
Ingredient (HICL) Xenon 133 In Air
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z5
Therapeutic class — intermediate (HIC2) Radiopharmaceuticals/Radiopharmaceutical Adjuvants
HIC3 code Z5D
Therapeutic class — specific (HIC3) Radioactive Diagnostics, General
AHFS code 36:00.00.00
AHFS class Diagnostic Agents
FDB label name XENON XE-133 370 MBQ (10 MCI)
FDB brand name Xenon Xe-133
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 083724
  • GCN: 52766
  • HICL (First Databank): 048216
  • AHFS class code: 36:00.00.00
Why two NDCs? The FDA registers this code as 69945-097-11 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69945-0097-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name XENON XE-133 370 MBQ (10 MCI) Ingredient Xenon 133 In Air

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 3 cans 5 cans
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69945-0097-11 You're viewing this Main listing 1 CAN in 1 CONTAINER / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE 2016-03-30 — Active
69945-0097-13 69945-097-13 3 CAN in 1 CONTAINER / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE 2016-03-30 — Active
69945-0097-15 69945-097-15 5 CAN in 1 CONTAINER / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE 2016-03-30 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 can in 1 container / 1 bottle in 1 can / 2 ml in 1 bottle.
What NDC number is used to bill for this package of Xenon, Xe-133 5 mCi/mL Gas?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Xenon, Xe-133 5 mCi/mLthis 69945-0097-11 Curium 1 can — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Mar 2016
📍
2026
Currently FDA-listed
10 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII K21NZZ5Y0B
    A gas that makes up Earth's atmosphere. In medicines, air is sometimes intentionally included or trapped during manufacturing to create foam formulations, improve texture, or help with product stability and delivery.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCurium US LLC
Application holderCURIUM US LLC
FDA applicationNDA018327 (NDA)
Labeler code69945
First marketedMar 2016
Product typeHuman Prescription Drug
Portfolio34 products on file

More NDCs from Curium US LLC labeler code 69945

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

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 140 words ▾

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 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 67 words ▾

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 15 words ▾

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

🤰 Pregnancy 85 words ▾

Pregnancy Animal reproduction studies have not been conducted with Xenon Xe 133 Gas. It is also not known whether Xenon Xe 133 Gas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Xenon Xe 133 Gas should be given to a pregnant woman only if clearly needed.

Ideally, all examinations that use radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧬 Clinical Pharmacology 104 words ▾

CLINICAL PHARMACOLOGY Xenon Xe 133 is a readily diffusible gas which is neither utilized nor produced by the body. It passes through cell membranes, freely exchanges between blood and tissue, and tends to concentrate more in body fat than in blood, plasma, water or protein solutions. In the concentrations recommended for diagnostic studies, it is physiologically inactive.

Inhaled Xenon Xe 133 Gas will enter the alveolar wall and the pulmonary venous circulation via capillaries. Most of the Xenon Xe 133 Gas that enters the circulation from a single breath is returned to the lungs and exhaled after a single pass through the peripheral circulation.

📦 How Supplied / Storage and Handling 49 words ▾

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.

📦 Storage and Handling 85 words ▾

STORAGE Xenon Xe 133 Gas should be stored at controlled room temperature 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in Sections 35.200 and to persons who hold an equivalent license issued by an Agreement State. ©2022 Curium US LLC. Curium TM and the Curium logo are trademarks of a Curium company.

Curium US LLC Maryland Heights, MO 63043 USA A097I0 R07/2022 CURIUM™

📋 Description 179 words ▾

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 <0.6 <1.0 <0.03 <0.01 0 Calibration Date >98.1 <0.3 <1.5 <0.06 <0.01 7 >97.2 <0.08 <2.5 <0.15 <0.02 14 Expiration Date >95.7 <0.02 <4.1 <0.37 <0.02

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General Xenon Xe 133 Gas as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Also, care should be taken to minimize radiation exposure to the patients consistent with proper patient management. Exhaled Xenon Xe 133 Gas should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of radionuclides.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential or whether this drug affects fertility in males or females. Pregnancy Animal reproduction studies have not been conducted with Xenon Xe 133 Gas.

It is also not known whether Xenon Xe 133 Gas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Xenon Xe 133 Gas should be given to a pregnant woman only if clearly needed. Ideally, all examinations that use radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xenon Xe 133 Gas is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🍼 Nursing Mothers 37 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xenon Xe 133 Gas is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 28 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential or whether this drug affects fertility in males or females.

📄 Package Label / Principal Display Panel 86 words ▾

PRINCIPAL DISPLAY PANEL - 10 mCi XENON Xe 133 GAS 370 MBq (10 mCi)/vial CAUTION RADIOACTIVE MATERIAL Single Dose Container -Dispose in Accordance with Regulatory Requirements. For use with Xenotron™ I Xenon Gas Dispenser only. Rx only Curium US LLC A097V0 R03/2019 Label

PRINCIPAL DISPLAY PANEL - 20 mCi XENON Xe 133 GAS 740 MBq (20 mCi)/vial CAUTION RADIOACTIVE MATERIAL Single Dose Container -Dispose in Accordance with Regulatory Requirements. For use with Xenotron™ I Xenon Gas Dispenser only. Rx only Curium US LLC A098V0 R03/2019 Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Curium US LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 3 cans (69945-0097-13), 5 cans (69945-0097-15). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Curium US LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 69945-0096-20 · Curium 69945-0098-21 · Curium →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.