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Myoview Tetrofosmin .23 mg Injection, Powder, Lyophilized, For Solution, 5 vials — NDC 17156-024-05 (Billing 17156-0024-05)

by Medi-Physics Inc. dba GE Healthcare · 5 VIAL in 1 KIT / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

This is a package of 5 vials of Myoview Tetrofosmin .23 mg Injection, Powder, Lyophilized, For Solution from Medi-Physics Inc. dba GE Healthcare, marketed since Feb 1996 and currently FDA-listed. It is this product's only package size.

NDC 17156-0024-05
🏷️ FDA NDC (as labeled) 17156-024-05 billing pads the product segment with a zero
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 →

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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 17156-024-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
17156 labeler · 024 product · 05 package
Package marketed since
Mar 1, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
5 EA per package
Barcode (UPC-A, from the NDC)
3 1715602405 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 17156-024-05
Product NDC 17156-024
11-digit billing NDC 17156002405
NCPDP billing unit EA — each (per item)
UNII 3J0KPB596Q
Application # NDA020372
SPL Set ID 4a8e5ed7-57f4-4d48-93cd-5f307207a3a0
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1996-02-09
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance TETROFOSMIN

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

GPI-14 94353080756400
GPI class Myoview
GCN Seq No 062764
GCN 98538
HICL code 024544
Ingredient (HICL) Kit For Prep Tc-99M/Tetrofosmn
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A6
Therapeutic class — intermediate (HIC2) Cardiovascular Diagnostic Agents
HIC3 code A6W
Therapeutic class — specific (HIC3) Cardiovascular Diagnostics - Radioactive
AHFS code 36:18.00.00
AHFS class Cardiac Function
FDB label name MYOVIEW 10 ML VIAL KIT
FDB brand name Myoview
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 062764
  • GCN: 98538
  • GPI-14 (Medi-Span): 94353080756400
  • HICL (First Databank): 024544
  • AHFS class code: 36:18.00.00
Why two NDCs? The FDA registers this code as 17156-024-05 — 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 → 17156-0024-05. 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 MYOVIEW 10 ML VIAL KIT Ingredient Kit For Prep Tc-99M/Tetrofosmn

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 mLPer 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.
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
17156-0024-05 You're viewing this Main listing 5 VIAL in 1 KIT / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 2022-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Myoview .23 mgthis 17156-0024-05 Medi-Physics 5 vials — — 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

🏛️
1996
First FDA approval
Feb 1996
📍
2026
Currently FDA-listed
30 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 9, 1996 RLD RS ⏳ ~3.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9549999 — drug product
1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026 2028 2030
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 9549999 ↗ Drug product — Mar 10, 2030
Common questions
Is there a generic version of MYOVIEW 10 ML VIAL KIT?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for MYOVIEW 10 ML VIAL KIT. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2030 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerMedi-Physics Inc. dba GE Healthcare
Application holderMEDI-PHYSICS INC DBA GE HEALTHCARE
FDA applicationNDA020372 (NDA)
Labeler code17156
First marketedFeb 1996
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from Medi-Physics Inc. dba GE Healthcare labeler code 17156

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 148 words ▾

1 INDICATIONS AND USAGE MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin for injection. Technetium Tc99m tetrofosmin injection is a radioactive diagnostic agent indicated for the following: Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease ( 1.1 ) Assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease ( 1.2 )

1.1Myocardial Perfusion Imaging Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease.

1.2Ventricular Function Imaging MYOVIEW is indicated for assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Use appropriate radiation safety measures and aseptic technique during preparation and handling ( 2.1 , 2.3 ) The recommended dose range for MYOVIEW for rest or stress imaging is 185 to 1,221 megabecquerels (MBq) [5 to 33 millicuries (mCi)] by intravenous administration ( 2.2 ) When rest and stress injections are administered on the same day, the first dose should be 185 to 444 MBq (5 to 12 mCi) followed by the second dose of 555 to 1,221 MBq (15 to 33 mCi) given approximately 1 to 4 hours later ( 2.2 ) The recommended dose range for MYOVIEW for ventricular function assessment is 185 to 1,221 MBq (5 to 33 mCi) as an intravenous injection ( 2.2 ) See Full Prescribing Information for instructions for preparation and determination of radiochemical purity ( 2.4 , 2.5 ) Imaging may begin 15 minutes following administration of the agent ( 2.6 )

2.1Radiation Safety – Drug Handling Technetium Tc99m tetrofosmin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.2) ] . Use waterproof gloves and effective shielding, including syringe shields, when preparing and administering technetium Tc99m tetrofosmin injection.

2.2Recommended Dosage The recommended dose range for MYOVIEW is 185 to 1,221 megabecquerels (MBq) (5 to 33 millicuries (mCi) by intravenous administration for rest and stress imaging. When rest and stress intravenous injections are administered on the same day, the first dose should be 185 to 444 MBq (5 to 12 mCi) and followed by the second dose of 555 to 1,221 MBq (15 to 33 mCi) given approximately 1 to 4 hours later. The recommended dose range for MYOVIEW is 185 to 1,221 MBq (5 to 33 millicuries (mCi) by intravenous administration as an intravenous injection for ventricular function assessment.

2.3Administration Instructions Use aseptic technique for all drug preparation and handling. Measure the dose in a suitable radioactivity calibration system immediately prior to intravenous administration. Visually inspect the drug for particulate matter and discoloration prior to administration.

Do not use or administer the drug if there is evidence of particulate matter or discoloration. Instruct patients to remain hydrated and void frequently following administration to decrease radiation exposure [see Warnings and Precautions (5.2) ].

2.4Instructions for Preparation The following steps as detailed are critical and should be followed to ensure adequate preparation of the product. The technetium Tc99m labeling reaction involved in the preparation of MYOVIEW Injection depends on maintaining tin in the divalent (reduced) state. Any oxidant present in the sodium pertechnetate Tc99m used may adversely affect the quality of the preparation.

Sodium pertechnetate Tc99m containing oxidants should not be used for the preparation of the labeled product. Elute the technetium generator with sodium chloride injection, USP. Insert a venting needle (standard 18 to 26 gauge needle, not provided) through the rubber septum of the shielded vial containing the lyophilized powder.

Inject no more than

8.8GBq (240 mCi) of technetium Tc99m generator eluate into the shielded vial. Use sodium chloride injection, USP as a diluent. Inject 4 to 8 mL to achieve a radioactive concentration no greater than

1.1GBq/mL (30 mCi/mL) in the vial. Before removing the syringe from the vial, withdraw 2 mL of gas from above the solution. Remove the venting needle.

Mix gently for 10 seconds to ensure complete dissolution of the powder. Incubate at room temperature for 15 minutes. Assay the total activity using a suitably calibrated instrument; complete the user radiation label and attach it to the vial.

Measure the pH of the prepared injection and verify it is between 7.5 to 9.0. Store the radiolabeled MYOVIEW vial at 2° to 25°C (36° to 77°F) and use radiolabeled injection within 12 hours of preparation.

2.5Determination of Radioche… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 98 words ▾

3 DOSAGE FORMS AND STRENGTHS Kit for the preparation of technetium Tc99m tetrofosmin injection: 10 mL multiple-dose, clear, glass vial with a white sterile, non-pyrogenic, lyophilized powder of 0.23 mg tetrofosmin, 0.03 mg stannous chloride dihydrate, 0.32 disodium sulphosalicylate, 1 mg sodium D-gluconate and 1.8 mg sodium hydrogen carbonate. Following radiolabeling with the Tc99m eluate, MYOVIEW is a clear solution not exceeding 1,110 MBq/mL (30 mCi/mL) of Tc99m. Kit for preparation injection: lyophilized powder containing 0.23 mg tetrofosmin in a multiple-dose vial after radiolabeling with Tc99m eluate, clear solution not exceeding 1,110 MBq/mL (30 mCi/mL).

( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Risk with exercise or pharmacologic stress: Continuous cardiac monitoring should be performed in studying patients with known or suspected coronary artery disease ( 5.1 ) When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent's prescribing information ( 5.1 ) Appropriate safety measures should be used to minimize radiation exposure to clinical personnel and to the patient consistent with proper patient management ( 2.1 , 5.2 )

5.1Risks Associated with Exercise or Pharmacologic Stress Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular reactions such as headache, paraesthesias, convulsions, somnolence and cerebrovascular accident, including hemorrhage. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent's prescribing information.

5.2Radiation Risks Technetium Tc99m contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation radiolabeling procedures to protect patients and health care workers from unintentional radiation exposure.

Encourage adequate hydration; instruct patients to void when the examination is completed and as often thereafter as possible [see Dosage and Administration (2.1) and (2.3) ] .

5.3Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, throat tightness, coughing, tachycardia, chest pain, hypotension, abdominal pain, and cutaneous reactions (rash, urticaria, pruritus, erythema, and swelling or angioedema) have been observed after the administration of MYOVIEW. Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence < 1%) after MYOVIEW injection: Cardiovascular: angina, hypertension, torsades de pointes. Gastrointestinal: vomiting, abdominal discomfort. Hypersensitivity: cutaneous allergy, hypotension, dyspnea.

Special Senses: metallic taste, burning of the mouth, smell alteration. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of MYOVIEW cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions were evaluated in clinical studies (using an exercise/rest protocol) of 764 adults (511 men and 253 women) with a mean age of 58.7 years (range 29 to 94 years). The subjects received a mean dose of 285 MBq (7.7 mCi) on the first injection and 829 MBq (22.4 mCi) on the second injection of MYOVIEW.

After MYOVIEW injection, angina occurred in 4 subjects, ventricular tachycardia in 1 subject, and respiratory arrest in 1 subject. The following reactions were noted in less than 1% of subjects: Cardiovascular: angina, hypertension, torsades de pointes. Gastrointestinal: vomiting, abdominal discomfort.

Hypersensitivity: cutaneous allergy, hypotension, dyspnea. Special Senses: metallic taste, burning of the mouth, smell alteration. In four studies, 438 adults (232 men and 205 women: gender was not recorded for one subject) with a mean age of 65 years (range 27 to 97 years) received a single pharmacologic stress agent.

The subjects received a mean dose of 7 to 8 mCi on the rest/first injection and 22 to 34 mCi on the stress/second injection. Among the 438 subjects, 319 subjects (73%) experienced an adverse reaction. Reactions occurring in ≥1% of the subjects included angina (39%), flushing (36%), dyspnea (28%), headache (14%), abdominal pain (11%), dizziness (7%), palpitations (2%), nausea (2%), hypotension (1%) and pain (1%).

Events occurring in <1% include cough, arrhythmia, bronchospasm, ECG abnormalities, hypertension, vomiting and asthenia.

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of MYOVIEW. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions reported included: rash, urticaria, abnormal vision, hypersensitivity reactions, and fever.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Advise the pregnant woman of the potential risk to the fetus based on the radiation dose from technetium Tc99m and the gestational timing of exposure ( 8.1 ) Lactation - A lactating woman should pump and discard breastmilk for 60 hours after technetium Tc99m tetrofosmin administration ( 8.2 )

8.1Pregnancy Risk Summary There are no data with technetium Tc99m tetrofosmin use in pregnant women to inform any drug associated risks. Animal reproduction studies with technetium Tc99m tetrofosmin have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

If considering technetium Tc99m tetrofosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary Technetium Tc99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose). There are no data available regarding the effects of technetium Tc99m tetrofosmin on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for MYOVIEW and any potential adverse effects on the breastfed child from MYOVIEW or from the underlying maternal condition.

Clinical Considerations To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 60 hours (10 half-lives) after technetium Tc99m tetrofosmin administration.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Of 2,300 subjects in clinical studies of MYOVIEW, 1,053 (46%) were 65 or older and 270 (12%) were 75 or older. No overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🤰 Pregnancy 134 words ▾

8.1Pregnancy Risk Summary There are no data with technetium Tc99m tetrofosmin use in pregnant women to inform any drug associated risks. Animal reproduction studies with technetium Tc99m tetrofosmin have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

If considering technetium Tc99m tetrofosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 64 words ▾

8.5Geriatric Use Of 2,300 subjects in clinical studies of MYOVIEW, 1,053 (46%) were 65 or older and 270 (12%) were 75 or older. No overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology 171 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Technetium (99mTc) tetrofosmin is a lipophilic, cationic complex which diffuses passively through the cell membrane and is locally retained actively due to the presence of intact mitochondria reflecting the presence of viable cells. After intravenous injection, it is distributed within the myocardium according to myocardial perfusion and viability.

12.2Pharmacodynamics The relationship between Tc99m tetrofosmin plasma concentrations and successful imaging has not been explored in clinical trials.

12.3Pharmacokinetics Uptake in the myocardium is dependent on coronary flow and reaches a maximum of 1.2% of the injected dose (i.d.) at 5 minutes and 1% of the i.d. at 2 hours, respectively. Background activities in the blood, liver and lung were less than 5% of the administered activity in whole blood at 10 minutes post-injection, less than 4.5% i.d., after 60 minutes, and less than 2% i.d. after 30 minutes. Elimination Approximately 66% of the injected activity is excreted within 48 hours post-injection, with approximately 40% excreted in the urine and 26% in the feces.

🧬 Mechanism of Action 52 words ▾

12.1Mechanism of Action Technetium (99mTc) tetrofosmin is a lipophilic, cationic complex which diffuses passively through the cell membrane and is locally retained actively due to the presence of intact mitochondria reflecting the presence of viable cells. After intravenous injection, it is distributed within the myocardium according to myocardial perfusion and viability.

📦 How Supplied / Storage and Handling 208 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How supplied Five (5) multiple-dose kits, each containing a 10 mL glass vial with a sterile, non-pyrogenic, lyophilized powder containing 0.23 mg tetrofosmin, 0.03 mg stannous chloride dihydrate, 0.32 mg disodium sulphosalicylate, 1 mg sodium D-gluconate, 1.8 mg sodium hydrogen carbonate. NDC 17156-024-05 The radionuclide is not part of the kit. Before radiolabeling with Tc99m, the contents of the kit are not radioactive.

16.2Storage and Handling Store the kit at 2° to 8°C (36° to 46°F), protected from light. Store the radiolabeled vial at 2° to 25°C (36° to 77°F), using appropriate radiation shielding. Use within 12 hours of preparation.

This reagent kit is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State; store and dispose of technetium Tc99m tetrofosmin in accordance with these regulations.

16.1How supplied Five (5) multiple-dose kits, each containing a 10 mL glass vial with a sterile, non-pyrogenic, lyophilized powder containing 0.23 mg tetrofosmin, 0.03 mg stannous chloride dihydrate, 0.32 mg disodium sulphosalicylate, 1 mg sodium D-gluconate, 1.8 mg sodium hydrogen carbonate. NDC 17156-024-05 The radionuclide is not part of the kit. Before radiolabeling with Tc99m, the contents of the kit are not radioactive.

📦 Storage and Handling 75 words ▾

16.2Storage and Handling Store the kit at 2° to 8°C (36° to 46°F), protected from light. Store the radiolabeled vial at 2° to 25°C (36° to 77°F), using appropriate radiation shielding. Use within 12 hours of preparation.

This reagent kit is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State; store and dispose of technetium Tc99m tetrofosmin in accordance with these regulations.

📋 Description ~2 min read ▾

11 DESCRIPTION

11.1Chemical Characteristics MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin injection for intravenous use. Technetium Tc99m tetrofosmin is a radioactive diagnostic agent. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, lyophilized powder of 0.23 mg tetrofosmin [6,9-bis(2-ethoxyethyl)-3,12-dioxa-6,9-diphosphatetradecane], 0.03 mg stannous chloride dihydrate, (minimum stannous tin 0.015 mg; total stannous and stannic tin 0.0522 mg) 0.32 mg disodium sulphosalicylate, 1 mg sodium D-gluconate, and 1.8 mg sodium hydrogen carbonate.

The lyophilized powder is sealed under a nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. The chemical formula of tetrofosmin is C 18 H 40 O 4 P 2 with the following structural formula: C 18 H 40 O 4 P 2 When sterile, pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial, a Tc99m complex of tetrofosmin is formed.

The radiolabeled product is a clear solution and the pH is in the range of 7.5 to 9.0. Chemical Structure

11.2Physical Characteristics Technetium Tc99m decays by isomeric transition with a physical half-life of 6 hours. Photons that are useful for imaging studies are listed in Table 2. Table 2 Principal radiation emission data - technetium Tc99m Radiation Mean % disintegration Mean energy (keV) Gamma 2 88.5 140.5

11.3External Radiation The air-kerma-rate (exposure-rate) constant for technetium Tc99m is 5.23 m 2 ∙pGy∙(MBq) −1 ∙s −1 [0.795 cm 2 ∙R∙(mCi) −1 ∙h −1 ]. A range of values for the relative radiation attenuation by various thicknesses of Pb shielding is shown in Table 3. For example, the use of 3 mm thick Pb will decrease the external radiation exposure by a factor of approximately 1,000.

Table 3 Radiation attenuation by lead shielding Shield thickness (Pb) mm Factor of attenuation 0.25 0.5 1 10 -1 2 10 -2 3 10 -3 4 10 -4 5 10 -5 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 4. Table 4 Physical decay chart - Tc99m half-life 6 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time (time of preparation) 1.000 7 0.446 1 0.891 8 0.397 2 0.794 9 0.354 3 0.707 10 0.315 4 0.630 11 0.281 5 0.562 12 0.250 6 0.500 24 0.063

💬 Information for Patients 46 words ▾

17 PATIENT COUNSELING INFORMATION Instruct patients to remain hydrated and void frequently following administration to decrease radiation exposure. Advise a lactating woman to pump and discard breast milk for 60 hours (10 half-lives) after technetium Tc99m tetrofosmin administration to decrease radiation exposure to the breastfed infant.

🧬 Pharmacokinetics 97 words ▾

12.3Pharmacokinetics Uptake in the myocardium is dependent on coronary flow and reaches a maximum of 1.2% of the injected dose (i.d.) at 5 minutes and 1% of the i.d. at 2 hours, respectively. Background activities in the blood, liver and lung were less than 5% of the administered activity in whole blood at 10 minutes post-injection, less than 4.5% i.d., after 60 minutes, and less than 2% i.d. after 30 minutes. Elimination Approximately 66% of the injected activity is excreted within 48 hours post-injection, with approximately 40% excreted in the urine and 26% in the feces.

🧬 Pharmacodynamics 19 words ▾

12.2Pharmacodynamics The relationship between Tc99m tetrofosmin plasma concentrations and successful imaging has not been explored in clinical trials.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Exercise/Resting Myocardial Perfusion Imaging Studies A total of 252 subjects with ischemic heart disease or atypical chest pain were studied in two open-label, multi-center, clinical studies (study a and study b). Of these 252 subjects there were 212 (84%) males and 40 (16%) females with a mean age of 60.5 years (range 33.7 to 82.4 years). All subjects had exercise and rest planar imaging with MYOVIEW and thallium-201; 191 (76%) subjects also had single photon emission computed tomography (SPECT) imaging.

At peak exercise, maximum heart rate achieved and peak systolic blood pressure were comparable after MYOVIEW and thallium-201 exercise studies. The MYOVIEW and thallium-201 images were separated by a mean of 5.1 days (1 to 14 days before or 2 to 14 days after MYOVIEW). For MYOVIEW imaging, each subject received 185 to 296 MBq (5 to 8 mCi) Tc99m tetrofosmin at peak exercise and 555 to 888 MBq (15 to 24 mCi) Tc99m tetrofosmin at rest approximately 4 hours later.

For thallium-201 imaging, subjects received thallium-201 55.5 to 74 MBq (1.5 to 2 mCi) at peak exercise. The images were evaluated for the quality of the image (excellent, good or poor) and the diagnosis (with scores of 0 = normal, 1 = ischemia, 2 = infarct, 3 = mixed infarct and ischemia). The primary outcome variable was the percentage of correct diagnoses in comparison to the final clinical diagnosis.

All planar images were blindly read; SPECT images were evaluated by the unblinded investigator. The results for each blinded reader are noted in Table 5. Table 5 Overall Diagnostic Outcome Thallium 201 MYOVIEW Reader 1 Reader 2 Reader 1 Reader 2 Diagnosis Study % (95% CI) % (95% CI) % (95% CI) % (95% CI) Ischemia a 77.7 (68.8, 85.0) 75.0 (65.9, 82.7) 66.3 (56.7, 75.1) 63.6 (53.9, 72.6) b 75.6 (66.9, 83.0) 68.9 (59.8, 77.1) 66.4 (57.2, 74.8) 66.4 (57.2, 74.8) Infarct a 75.9 (66.9, 83.5) 75.0 (65.9, 82.7) 74.5 (65.4, 82.4) 75.5 (66.3, 83.2) b 70.6 (61.5, 78.6) 69.7 (60.7, 77.8) 73.1 (64.2, 80.8) 68.1 (58.9, 76.3)

14.2Pharmacological Stress Myocardial Perfusion Imaging Studies MYOVIEW imaging after pharmacologic stress was evaluated in two studies in subjects with known or suspected coronary artery disease (CAD). Three blinded reads were obtained for 57 subjects (45 male [79%], 12 female [21%]; mean age 60.1 years) all of whom had angiography. Subject level analyses were based on the finding of SPECT myocardial perfusion abnormalities in patients with angiographically confirmed disease.

Subject level sensitivities for MYOVIEW ranged from 68 to 83% and subject level specificities ranged from 45 to 82% across readers and studies.

14.3Ventricular Function Stress Myocardial Perfusion Imaging Studies Two open-label, multicenter, identically designed, blinded image read studies were conducted to assess left ventricular function using MYOVIEW ECG gated SPECT (GSPECT) myocardial perfusion imaging. A total of 329 subjects (216 male [65.7%], 113 female [34.3%]); mean age of 60.4 years) with known or suspected heart disease or requiring ventricular function assessments were dosed with MYOVIEW. Of these, 297 were considered evaluable.

MYOVIEW was administered at rest and at peak stress using either a one-day or a 2-day dosing protocol. For both studies, all subjects' stress GSPECT exams were compared to the reference exam of radionuclide ventriculography with Tc99m labeled RBCs (multiple gated acquisition [MUGA]), performed 1 to 5 days after the second MYOVIEW injection. All subjects' GSPECT exams were assessed by 3 independent blinded readers per study.

The MUGA exams were evaluated by an independent consensus panel composed of 3 blinded readers. Subject level assessments were based upon discrimination between normal and abnormal values for LVEF (LVEF ≥50% was considered normal) and normal and abnormal wall motion as judged visually. Sensitivity and specificity of LVEF determinations ranged from 81% to 88% and 76% to 85% respectively across studies and rea… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 50 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been conducted to evaluate carcinogenic potential or effects on fertility. Tetrofosmin sulphosalicylate was not mutagenic in vitro in the Ames test, mouse lymphoma, or human lymphocyte tests, nor was it clastogenic in vivo in the mouse micronucleus test.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 47 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been conducted to evaluate carcinogenic potential or effects on fertility. Tetrofosmin sulphosalicylate was not mutagenic in vitro in the Ames test, mouse lymphoma, or human lymphocyte tests, nor was it clastogenic in vivo in the mouse micronucleus test.

📄 Package Label / Principal Display Panel 37 words ▾

PRINCIPAL DISPLAY PANEL - 5 Vial Kit Label MYOVIEW™ (Kit for the Preparation of Technetium Tc99m Tetrofosmin Injection) 10 mL 5 x 10 mL multiple-dose vials 0.23 mg/vial tetrofosmin PRINCIPAL DISPLAY PANEL - 5 Vial Kit Label

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

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 Tetrofosmin — the ingredient across all brands.

Top reported reactions

Radioisotope Scan Abnormal274
Product Quality Issue29
Dizziness21
Headache21
Nausea20
Hypersensitivity16
Scan Myocardial Perfusion Abnormal16

Age at onset

Adult8
Elderly2

Reporter sex

692 reports
Male · 50%
Female · 49%
Unknown · 2%

Serious outcomes

Hospitalization55
Life-threatening19
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 98 28
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.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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 Medi-Physics Inc. dba GE Healthcare. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medi-Physics Inc. dba GE Healthcare 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.
← 17156-0022-05 · Medi-Physics 17156-0025-05 · Medi-Physics, →
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.