NDC 87333-0127-11 — Xenon 10 mCi Gas, 1 vial

🆔 Identity & classification

FDA NDC (as labeled) 87333-127-11

Product NDC 87333-127

11-digit billing NDC 87333012711

UNII X3P9A5HNYF

Application # NDA017284

SPL Set ID 74f95143-d3b4-4e69-b200-e09bf811516b

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 2026-09-10

Route RESPIRATORY (INHALATION)

Dosage form GAS

Substance XENON XE-133

Why two NDCs? The FDA registers this code as 87333-127-11 — 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 → 87333-0127-11. 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.

🏭 Manufacturer & labeler

LabelerShine Spect USA, LLC

Application holderSHINE SPECT USA LLC

FDA applicationNDA017284 (NDA)

Labeler code87333

First marketedSep 2026

Product typeHuman Prescription Drug

Portfolio4 products on file

🔎 All NDCs from Shine Spect USA, LLC

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.

🩺 Clinical

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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 142M471B3J
Carbon dioxide is a colorless gas used in medicines as a propellant in pressurized inhalers and aerosol sprays to help deliver the active medication to where it's needed.

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.

💲 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 system	Per each	Per 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: 5 vials

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Xenon 10 mCi 11994-0127-11	Lantheus	1 vial	—	—	FDA listed	—
Xenon 10 mCithis 87333-0127-11	Shine	1 vial	—	—	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

🏛️

2026

On the market since

Sep 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔒

·

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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Xenon (this brand).

Top reported reactions

Occupational Exposure To Product4

Nasal Discomfort2

Throat Irritation2

Urticaria2

Accidental Exposure1

Alanine Aminotransferase Decreased1

Beta 2 Microglobulin Increased1

Reporter sex

Male · 44%

Female · 56%

Serious outcomes

Hospitalization1

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
87333-0127-11 You're viewing this	1 VIAL in 1 CAN (87333-127-11) / 1 GAS in 1 VIAL	2026-09-10	Active
87333-0127-15	5 VIAL in 1 CAN (87333-127-15) / 1 GAS in 1 VIAL	2026-09-10	Active

Pack size FAQ

What quantity is in NDC 87333-0127-11?

NDC 87333-0127-11 contains 1 vial — 1 vial in 1 can / 1 gas in 1 vial.

What is the difference between NDC 87333-0127-11 and NDC 87333-0127-15?

Both are Xenon 10 mCi Gas — the drug itself is identical. NDC 87333-0127-11 is the 1 vial package, while NDC 87333-0127-15 is the 5 vials package.

What NDC number is used to bill for this package of Xenon 10 mCi Gas?

Bill NDC 87333-0127-11 — the 11-digit billing format is 87333012711. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 87333-127-11, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 87333-0127-11, written without dashes as 87333012711. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 87333-0127-11, the first segment (87333) is the labeler code FDA assigned to Shine Spect USA, LLC; the middle segment (0127) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Shine Spect USA, 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 1 other package presentation of this same product, including 5 vials (87333-0127-15). 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?

Shine Spect USA, 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.

📄 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 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 33 words ▾

INDICATIONS AND USAGE: Inhalation of Xenon Xe 133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs. It may also be applied to assessment of cerebral flow.

⏱️ Dosage and Administration 178 words ▾

DOSAGE AND ADMINISTRATION: Xenon Xe 133 Gas is administered by inhalation from closed respirator systems or spirometers. The suggested activity range employed for inhalation by the average adult patient (70 kg) is: Pulmonary function including imaging: 74-1110 MBq (2-30 mCi) in 3 liters of air. Cerebral blood flow: 370-1110 MBq (10-30 mCi) in 3 liters of air.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. RADIATION DOSIMETRY The estimated absorbed radiation doses 2 to an average patient (70 kg) for pulmonary perfusion and cerebral blood flow studies from a maximum dose of 1110 MBq (30 mCi) of Xenon Xe 133 in 3 liters of air are shown in Table 4. Table 4.

Radiation Doses Effective Whole Half-Time Lungs* Brain Body *99% of activity is in lungs. 2 Method of Calculation: A Schema for Absorbed-Dose Calculation for Biologically Distributed Radionuclides, Supplement No. 1, MIRD pamphlet No.

1, J. Nucl. Med., p.7 (1968). mGy/1110 MBq (rads/30 mCi) Pulmonary Perfusion 2 min.

2.5(0.25) 0.014(0.0014) 0.027(0.0027) Cerebral Blood Flow 5 min. 6.3(0.63) 0.035(0.0035) 0.068(0.0068)

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS: None known.

⚠️ Warnings 90 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 environs not specifically protected by exhaust systems. Xenon Xe 133 adheres to some plastics and rubber and should not be allowed to stand in tubing or respirator containers. The unrecognized loss of radioactivity from the dose for administration may render the study non-diagnostic.

The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

🤒 Adverse Reactions 17 words ▾

ADVERSE REACTIONS: Adverse reactions related to the use of this agent have not been reported to date.

🤰 Pregnancy 83 words ▾

Pregnancy Animal reproductive 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, examination using radiopharmaceuticals, especially those elective in nature in a woman of childbearing capability, should be performed during the first few (approximately 10) days following the onset of menses.

🧒 Pediatric Use 13 words ▾

Pediatric Use Safety and effectiveness in the pediatric population has not been established.

🧓 Geriatric Use 85 words ▾

Geriatric Use Clinical studies of Xenon Xe 133 Gas did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🧬 Clinical Pharmacology 106 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 and freely exchanges between blood and tissue. It tends to concentrate more in body fat than in blood, plasma, water or protein solutions.

In the concentrations used for diagnostic purposes it is physiologically inactive. Inhaled Xenon Xe 133 Gas will enter the alveolar wall and enter the pulmonary venous circulation via the capillaries. Most of the Xenon Xe 133 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 164 words ▾

HOW SUPPLIED: The Xenon Xe 133 Gas is supplied as part of the Calidose™ system, consisting of 3 mL unit dose vials and the Calidose™ dispenser for shielded dispensing. Normally vials containing either 370 or 740 MBq (10 or 20 mCi)/vial, packed 1 vial or 5 vials per shield tube, are supplied. The NDC number for: 10 mCi vial is 87333-127; 20 mCi vial is 87333-128.

Store at room temperature. This radiopharmaceutical is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.100 for the uses listed in 105 CMR 120.547 or 120.552 under equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

The contents of the vial are radioactive. Adequate shielding and handling precautions must be maintained. SHINE™ SHINE SPECT USA, LLC 325 Treble Cove Rd., N.

Billerica, MA 01862 USA For Ordering Tel. Toll Free 800-657-5426 (For Massachusetts & International, Call 978-330-9548) Patent: https://www.shinefusion.com/patents Printed in U.S.A. 515083-0126 January 2026

📋 Description ~2 min read ▾

DESCRIPTION: Xenon Xe 133 Gas is supplied in a mixture of xenon gas (5%) in carbon dioxide (95%). It is contained within septum sealed glass vials and is suitable for inhalation in the diagnostic evaluation of pulmonary function and imaging, as well as assessment of cerebral blood flow. Xenon Xe 133 Gas is reactor-produced as a by-product of Uranium U235 fission.

Each vial contains the labeled amount of Xenon Xe 133 radioactivity at the time of calibration. The contents of the vial are in gaseous form, contain no preservatives, and are ready for use. Xenon Xe 133 is chemically and physiologically related to elemental Xenon, a non-radioactive monoatomic gas which is physiologically inert except for anesthetic properties at high doses.

PHYSICAL CHARACTERISTICS Xenon Xe 133 decays by beta and gamma emissions with a half-life of 5.245 days. 1 Significant radiations which are emitted by the nuclide are listed in Table 1. Table 1.

Principal Radiation Emission Data from Xenon-133 Radiation Mean Energy (KeV) Mean % per Disintegration 1 Kocher, David C., "Radioactive Decay Data Tables," DOE/TIC-11026, p. 138, 1981. Beta-2 100.6

99.3Ce-K-2 45.0

53.3Ce-L-2 75.3

8.1Ce-M-2 79.8

1.7Gamma-2 81.0

36.5K α2 X-ray 30.6

13.6K α1 X-ray 31.0

25.3K β X-ray 35.0

9.1EXTERNAL RADIATION The specific gamma ray constant for Xenon Xe 133 is 3.6 microcoulombs/Kg-MBq-hr (0.51R/hr-mCi) at 1 cm. The first half value thickness of lead is 0.0035 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in Table 2.

For example, the use of 0.20 cm of Pb will decrease the external radiation exposure by a factor of 1,000. Table 2. Radiation Attenuation by Lead Shielding cm of Pb Radiation Attenuation Factor 0.0035 0.5 0.037 10 -1 0.12 10 -2 0.20 10 -3 0.29 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.

Table 3. Xenon Xe 133 Physical Decay Chart (Half Life 5.245 days) Fraction Fraction Day Remaining Day Remaining *Calibration Day 0* 1.000 8 .349 1 .877 9 .302 2 .768 10 .268 3 .674 11 .235 4 .591 12 .206 5 .518 13 .181 6 .452 14 .157 7 .398

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

🔗 Related NDC lookups

🧪 All Xenon Xe-133 NDCsSame ingredient 🏭 All Shine labeler NDCsLabeler code 87333 📚 All Inhalation Diagnostic Agent NDCsDrug class 📖 Read the Xenon Xe-133 drug informationUses, warnings & side effects