CardioGen-82 Rubidium Chloride RB-82 150 mCi Injection, Solution, 1 injection — NDC 0270-0091-01 (Billing 00270-0091-01)
This is a package of 1 injection of CardioGen-82 Rubidium Chloride RB-82 150 mCi Injection, Solution from Bracco Diagnostics Inc, marketed since Dec 1989 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 085180
- GCN: 54596
- HICL (First Databank): 049158
- AHFS class code: 36:68.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 mL | 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00270-0091-01 You're viewing this Main listing | 1 INJECTION, SOLUTION in 1 PACKAGE | 1989-12-30 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| CardioGen-82 150 mCithis 00270-0091-01 | Bracco | 1 injection | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL High Level Radiation Exposure with Use of Incorrect Eluent Patients are exposed to high radiation levels when the CardioGen-82 generator is eluted with the incorrect eluent due to high strontium (Sr) 82 and Sr 85 breakthrough levels. Use only additive-free 0.9% Sodium Chloride Injection to elute the generator. If an incorrect solution is used to elute the CardioGen-82 generator: Immediately stop the patient infusion; Evaluate the patient’s radiation absorbed dose, and monitor for the effects of radiation to critical organs such as bone marrow; Permanently discontinue the use of the affected generator [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ].
Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the Rubidium Chloride Rb 82 Injection exceed specified limits. Strictly adhere to the generator eluate testing protocol, to minimize the risk of excess radiation exposure, including daily testing and additional testing at Alert Limits. Stop using the generator if it reaches any of its Expiration Limits: 17 L for the generator’s cumulative eluate volume 60 days post generator calibration date An eluate Sr 82 level of 0.01 microCi /mCi Rb 82 An eluate Sr 85 level of 0.1 microCi /mCi Rb 82 [see Dosage and Administration ( 2.5 , 2.6 , 2.7 , 2.8 ) and Warnings and Precautions ( 5.2 )] WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL See full prescribing information for complete boxed warning.
High Level Radiation Exposure with Use of Incorrect Eluent Using the incorrect eluent can cause high Strontium (Sr) 82 and Sr 85 breakthrough levels. Use only additive-free 0.9% Sodium Chloride Injection to elute CardioGen-82. If an incorrect solution is used to elute CardioGen-82: Immediately stop the patient infusion; Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow; Permanently discontinue use of the affected generator.
( 2.5 , 2.9 , 5.1 ) Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the Rubidium Chloride Rb 82 Injection exceed limits. Strictly adhere to the generator eluate testing protocol. Stop using the generator if it reaches any of its Expiration Limits.
( 2.5 , 2.6 , 2.7 , 5.2 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, is indicated for positron emission tomography (PET) of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Dosing: 10 MBq/kg to 30 MBq/kg actual body weight (0.27 mCi/kg to 0.81 mCi/kg) per rest or stress component of a procedure via intravenous infusion at 50 mL/minute or 20 mL/minute. ( 2.2 ) Do not exceed a maximum dose of 2,220 MBq (60 mCi) or a maximum volume of 100 mL per rest or stress component of a procedure. ( 2.2 ) The minimum interval between the rest and stress doses is 10 minutes to allow sufficient Rb 82 decay.
( 2.2 ) Start image acquisition 60 seconds to 90 seconds after completion of the infusion; if a longer circulation time is anticipated, wait for 120 seconds. Image acquisition is 5 minutes long. ( 2.3 ) For radiation safety, infusion system, elution instruction, eluate testing, dose delivery, and expiration limits of CardioGen-82, and radiation dosimetry see full prescribing information.
( 2.1 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 )
2.1Radiation Safety - Drug Handling CardioGen-82, when eluted with additive-free 0.9% Sodium Chloride Injection, produces Rubidium Chloride Rb 82 Injection. Handle CardioGen-82, Rubidium Chloride Rb 82 Injection, and Infusion Systems with appropriate safety measures to minimize radiation exposure. Wear waterproof gloves and effective shielding throughout the entire preparation and handling [See Warnings and Precautions ( 5.4 )].
Limit the use of radiopharmaceuticals to healthcare providers who are qualified by specific 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.
2.2Dosing and Administration of Rubidium Chloride Rb 82 Injection Dosing The recommended dose of Rubidium Chloride Rb 82 Injection per rest or stress component of a PET MPI procedure in adults is 10 MBq/kg to 30 MBq/kg actual body weight (0.27 mCi/kg to 0.81 mCi/kg) administered by intravenous infusion at 50 mL/minute or 20 mL/minute through a catheter inserted into a large peripheral vein. Do not exceed a maximum dose of 2,220 MBq (60 mCi) or a maximum volume of 100 mL per rest or stress component of a procedure. Administration Instructions Observe aseptic techniques in all drug handling and administration.
Use CardioGen-82 with the CardioGen-82 Model 1700 Infusion System to elute and administer Rubidium Chloride Rb 82 Injection. Use the lowest dose necessary, consistent with the goal of as low as reasonably achievable (ALARA), to obtain adequate cardiac visualization based on patient body weight and the imaging equipment and acquisition methodology used to perform the procedure. For example, 3D image acquisition may require doses at the lower end of the recommended range, compared to 2D imaging.
Administer two single doses to complete rest and stress myocardial perfusion imaging (MPI) [see Dosage and Administration ( 2.3 )] . The minimum interval between the rest and stress doses is 10 minutes to allow sufficient Rb 82 decay. Instruct patients to void as soon as a study is completed and as often as possible thereafter for at least one hour [see Warnings and Precautions ( 5.4 )] .
2.3Image Acquisition Instructions Rest Imaging Administer a single dose of Rubidium Chloride Rb 82 Injection. Start imaging 60 seconds to 90 seconds after completion of the first dose infusion and acquire images for 5 minutes. Stress Imaging Begin the study at least 10 minutes after completion of the resting dose infusion, to allow for sufficient Rb 82 decay.
Administer a pharmacologic stress agent in accordance with its prescribing information. After the administration of the pharmacologic stress agent, administer the second dose of Rubidium Chloride Rb 82 Injection at the time interval according to the prescribing information of the pharmacologic stress agent. Start imaging 60 seconds to 90 seconds after completion of the second dose infusion and acquire images for 5 minutes.
Rest and Stress Imaging If a longer circulation time is anticipated (e.g., in a patien… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Rubidium Rb 82 generator used to produce Rubidium Chloride Rb 82 Injection: strontium-82 (Sr 82), with an activity of 3,330 MBq to 5,550 MBq (90 mCi to 150 mCi) at calibration time, adsorbed on a hydrous stannic oxide column. Rubidium Rb 82 generator used to produce Rubidium Chloride Rb 82 Injection: 3,330 MBq to 5,550 MBq (90 mCi to 150 mCi) of strontium-82 (Sr 82) at calibration time, adsorbed on a hydrous stannic oxide column. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk Associated with Pharmacological Stress: Pharmacologic induction of cardiovascular stress may cause serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, broncho-constriction, and cerebrovascular events. Perform testing only in setting where cardiac resuscitation equipment and trained staff are readily available. ( 5.3 )
5.1High Level Radiation Exposure with Use of Incorrect Eluent Additives present in solutions (particularly calcium ions) used by mistake to elute CardioGen-82 expose patients to high levels of radiation by causing the release of large amounts of Sr 82 and Sr 85 into the eluate regardless of the generator’s age or prior use . When solutions containing calcium ions are used, high levels of radioactivity are present in any subsequent eluate even with the use of additive-free 0.9% Sodium Chloride Injection. Use only additive-free 0.9% Sodium Chloride Injection to elute CardioGen-82.
If an incorrect eluent is used, immediately stop the patient infusion, evaluate the patient’s radiation absorbed dose, and monitor for the effects of radiation to critical organs such as bone marrow . Permanently discontinue use of the affected CardioGen-82 generator [see Dosage and Administration ( 2.5 )] .
5.2Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol Excess radiation exposure occurs when the Sr 82 and Sr 85 levels in the Rubidium Chloride Rb 82 Injection exceed the specified generator eluate limits. Strictly adhere to the eluate testing protocol to minimize radiation exposure to the patient. Stop using the CardioGen-82 generator when the expiration limits are reached [see Dosage and Administration ( 2.6 , 2.7 , 2.8 )].
5.3Risks Associated with Pharmacologic Stress Pharmacologic induction of cardiovascular stress may be associated with serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Perform pharmacologic stress testing in accordance with the pharmacologic stress agent’s prescribing information and only in the setting where cardiac resuscitation equipment and trained staff are readily available.
5.4Cumulative Radiation Exposure: Long-Term Risk of Cancer Rubidium chloride Rb 82 contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Use the lowest dose of Rubidium Chloride Rb 82 Injection necessary for imaging and ensure safe handling to protect the patient and health care providers .
Encourage patients to void as soon as a study is completed and as often as possible thereafter for a least one hour [see Dosage and Administration ( 2.1 , 2.2 )] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: High Level Radiation Exposure with Use of Incorrect Eluent [see Warnings and Precautions ( 5.1 )] Excess Radiation Exposure with Failure to Follow Eluate Testing Protocol [see Warnings and Precautions ( 5.2 )] The following serious adverse reactions have been identified during post-approval use of CardioGen-82. 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.
Radiation Exposure High level radiation exposure to the bone marrow from using an incorrect eluent. Excess radiation exposure due to insufficient eluate testing. To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-8151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Do not resume breastfeeding until at least one hour after administration of Rubidium Chloride Rb 82 Injection. ( 8.2 )
8.1Pregnancy Risk Summary There are no data available on the use of rubidium chloride Rb 82 in pregnant women. Animal reproductive studies have not been conducted with rubidium chloride Rb 82. However, all radiopharmaceuticals, including Rubidium Chloride Rb 82 Injection generated by CardioGen-82, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
If considering Rubidium Chloride Rb 82 Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from rubidium-82 (Rb 82) and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 There is no information regarding the presence of rubidium chloride Rb 82 in human milk, the effects on the breastfed infant or the effects on milk production. Due to the short half-life of Rb 82 (75 seconds), exposure of a breastfed infant through breast milk can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Rubidium Chloride Rb 82 Injection, any potential adverse effects on the breastfed child from Rb 82 or from the underlying maternal condition.
Clinical Considerations Exposure to Rb 82 through breast milk can be minimized if breastfeeding is discontinued when Rubidium Chloride Rb 82 Injection is administered. Do not resume breastfeeding until at least one hour after administration of Rubidium Chloride Rb 82 Injection.
8.4Pediatric Use The safety and effectiveness of CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, in pediatric patients have not been established.
8.5Geriatric Use In elderly patients with a clinically important decrease in cardiac function, lengthen the delay between infusion and image acquisition [see Dosage and Administration ( 2.3 )]. Observe for the possibility of fluid overload.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no data available on the use of rubidium chloride Rb 82 in pregnant women. Animal reproductive studies have not been conducted with rubidium chloride Rb 82. However, all radiopharmaceuticals, including Rubidium Chloride Rb 82 Injection generated by CardioGen-82, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
If considering Rubidium Chloride Rb 82 Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from rubidium-82 (Rb 82) and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 ▾
8.4Pediatric Use The safety and effectiveness of CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In elderly patients with a clinically important decrease in cardiac function, lengthen the delay between infusion and image acquisition [see Dosage and Administration ( 2.3 )]. Observe for the possibility of fluid overload.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Rb 82 is analogous to potassium ion (K + ) in its biochemical behavior and is extracted by the myocardium in proportion to the blood flow. Rb + participates in the sodium-potassium (Na + /K + ) ion exchange pumps that are present in cell membranes. The intracellular uptake of Rb 82 requires maintenance of ionic gradient across cell membranes.
Rb 82 radioactivity is increased in viable myocardium reflecting intracellular retention, while the tracer is cleared from necrotic or infarcted tissue.
12.2Pharmacodynamics In human studies, myocardial activity was noted within the first minute after peripheral intravenous injection of rubidium chloride Rb 82. When areas of infarction or ischemia are present in the myocardium, they are visualized within 2 minutes to 7 minutes after injection as photon-deficient, or “cold”, areas on the myocardial scan. In patients with reduced cardiac function, transit of the injected dose from the peripheral infusion site to the myocardium may be delayed [see Dosage and Administration ( 2.3 )].
Blood flow brings Rb 82 to all areas of the body during the first pass of circulation. Accordingly, visible uptake is also observed in other highly vascularized organs, such as the kidneys, liver, spleen, and lungs.
12.3Pharmacokinetics With a physical half-life of 75 seconds, Rb 82 is converted by radioactive decay into stable Kr 82 gas, which is passively expired by the lungs.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Rb 82 is analogous to potassium ion (K + ) in its biochemical behavior and is extracted by the myocardium in proportion to the blood flow. Rb + participates in the sodium-potassium (Na + /K + ) ion exchange pumps that are present in cell membranes. The intracellular uptake of Rb 82 requires maintenance of ionic gradient across cell membranes.
Rb 82 radioactivity is increased in viable myocardium reflecting intracellular retention, while the tracer is cleared from necrotic or infarcted tissue.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied CardioGen-82 (rubidium Rb 82 generator), used to produce Rubidium Chloride Rb 82 Injection, is supplied in a lead shield surrounded by a labeled plastic container with an activity at calibration time of 3,330 MBq to 5,550 MBq (90 mCi to 150 mCi) of Sr 82 adsorbed on a hydrous stannic oxide column (NDC 0270-0091-01). The container label provides complete assay data for each generator. Storage and Handling Store the generator at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
Receipt, transfer, possession, storage, disposal or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission (NRC), Agreement States or Licensing States as appropriate. Do not dispose of the generator in regular refuse systems.
For questions about the disposal of the CardioGen-82 generator, contact Bracco Diagnostics Inc. at 1-800-447-6883, option 3.
📋 Description ▾
11 DESCRIPTION
11.1Generator Characteristics CardioGen-82 (rubidium Rb 82 generator) contains accelerator-produced Sr 82 adsorbed on stannic oxide in a lead-shielded column and provides a means to produce sterile nonpyrogenic Rubidium Chloride Rb 82 Injection, a radioactive diagnostic agent, for intravenous use. The chemical form of Rb 82 is 82 RbCl. The amount (mCi) of Rb 82 obtained in each elution will depend on the potency of the generator.
When eluted at a rate of 50 mL/minute, each generator eluate at the end of elution should not contain more than 0.02 microCi of Sr 82 and not more than 0.2 microCi of Sr 85 per mCi of Rubidium Chloride Rb 82 Injection, and not more than 1 mcg of tin per mL of eluate.
11.2Nuclear Physical Characteristics Rb 82 decays by positron emission and associated gamma emission with a physical half-life of 75 seconds. Table 3 shows the annihilation photons released following positron emission which are useful for detection and imaging studies. The decay modes of Rb 82 are: 95.5% by positron emission, resulting in the production of annihilation radiation, i.e., two 511 keV gamma rays; and 4.5% by electron capture, resulting in the emission of “prompt” gamma rays of predominantly 776.5 keV.
Both decay modes lead directly to the formation of stable krypton 82 (Kr 82). Table 3. Principal Radiation Emission Data for Rb 82 Radiation Mean Percent Per Disintegration Mean Energy (keV) Annihilation photons (2) 191.01 511 (each) Gamma rays 13-15 776.5 The specific gamma ray constant for Rb 82 is
6.1R/hour-mCi at 1 cm. The first half-value layer is 0.7 cm of lead (Pb). Table 4 shows a range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead.
For example, the use of a 7.0 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. Table 4. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Attenuation Factor 0.7 0.5 2.3 10 -1 4.7 10 -2 7.0 10 -3 9.3 10 -4 Sr 82 (half-life of 25 days) decays to Rb 82.
To correct for physical decay of Sr 82, Table 5 shows the fractions that remain at selected intervals after the time of calibration. Table 5. Physical Decay Chart: Sr 82 half-life 25 days Days Fraction Remaining Days Fraction Remaining Days Fraction Remaining 0 Calibration time 1 21 0.559 41 0.321 1 0.973 22 0.543 42 0.312 2 0.946 23 0.529 43 0.304 3 0.920 24 0.514 44 0.295 4 0.895 25 0.500 45 0.287 5 0.871 26 0.486 46 0.279 6 0.847 27 0.473 47 0.272 7 0.824 28 0.460 48 0.264 8 0.801 29 0.448 49 0.257 9 0.779 30 0.435 50 0.250 10 0.758 31 0.423 51 0.243 11 0.737 32 0.412 52 0.237 12 0.717 33 0.401 53 0.230 13 0.697 34 0.390 54 0.224 14 0.678 35 0.379 55 0.218 15 0.660 36 0.369 56 0.212 16 0.642 37 0.359 57 0.206 17 0.624 38 0.349 58 0.200 18 0.607 39 0.339 59 0.195 19 0.591 40 0.330 60 0.189 20 0.574 To correct for physical decay of Rb 82, Table 6 shows the fraction of Rb 82 remaining in all 15 second intervals up to 300 seconds after time of calibration.
Table 6. Physical Decay Chart: Rb 82 half-life 75 seconds Seconds Fraction Remaining Seconds Fraction Remaining 0 Elution time 1 165 0.218 15 0.871 180 0.19 30 0.758 195 0.165 45 0.66 210 0.144 60 0.574 225 0.125 75 0.5 240 0.109 90 0.435 255 0.095 105 0.379 270 0.083 120 0.33 285 0.072 135 0.287 300 0.063 150 0.25
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Post-Study Voiding Instruct patients to void after completion of each image acquisition session and as often as possible for one hour after completion of the PET scan [see Warnings and Precautions ( 5.4 )] . Pregnancy Advise a pregnant woman of the potential risk to a fetus [see Use in Specific Populations ( 8.1 )] . Lactation Advise lactating women that exposure to Rb 82 through breast milk can be minimized if breastfeeding is discontinued when Rubidium Chloride Rb 82 Injection is administered.
Advise lactating women not to resume breastfeeding for at least one hour after administration of Rubidium Chloride Rb 82 Injection [see Use in Specific Populations ( 8.2 )] . Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08540 Manufactured By GE Healthcare, Medi-Physics, Inc.
Arlington Heights, IL 60004 CardioGen-82 ® Rubidium 82 Generators, Infusion Systems, and Accessories contain proprietary technology covered by one or more patents listed at www.braccoimaging.com/us-en/patents .
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics With a physical half-life of 75 seconds, Rb 82 is converted by radioactive decay into stable Kr 82 gas, which is passively expired by the lungs.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics In human studies, myocardial activity was noted within the first minute after peripheral intravenous injection of rubidium chloride Rb 82. When areas of infarction or ischemia are present in the myocardium, they are visualized within 2 minutes to 7 minutes after injection as photon-deficient, or “cold”, areas on the myocardial scan. In patients with reduced cardiac function, transit of the injected dose from the peripheral infusion site to the myocardium may be delayed [see Dosage and Administration ( 2.3 )].
Blood flow brings Rb 82 to all areas of the body during the first pass of circulation. Accordingly, visible uptake is also observed in other highly vascularized organs, such as the kidneys, liver, spleen, and lungs.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES In a descriptive, prospective, blinded image interpretation study of adult patients with known or suspected coronary artery disease, myocardial perfusion deficits in stress and rest PET images obtained with ammonia N 13 (n = 111) or rubidium chloride Rb 82 (n = 82) were compared to changes in stenosis flow reserve (SFR) as determined by coronary angiography. PET perfusion defects at rest and stress for seven cardiac regions (anterior, apical, anteroseptal, posterolateral, anterolateral, posterolateral, and inferior walls) were graded on a scale of 0 (normal) to 5 (severe).
Values for stenosis flow reserve, defined as flow at maximum coronary vasodilatation relative to rest flow, ranged from 0 (total occlusion) to 5 (normal). With increasing impairment of flow reserve, the subjective PET defect severity increased. A PET defect score of 2 or higher was positively correlated with flow reserve impairment (SFR<3).
A systematic review of published literature was conducted using pre-defined inclusion/exclusion criteria which resulted in identification of 10 studies evaluating the use of Rb 82 PET myocardial perfusion imaging (MPI) for the identification of coronary artery disease as defined by catheter-based angiography. In these studies, the patient was the unit of analysis and 50% stenosis was the threshold for clinically significant coronary artery disease (CAD). Of these 10 studies, 9 studies were included in a meta-analysis for sensitivity (excluding one study with 100% sensitivity) and 7 studies were included in a meta-analysis of specificity (excluding 3 studies with 100% specificity).
A random effects model yielded overall estimates of sensitivity and specificity of 92% (95% CI: 89% to 95%) and 81% (95% CI: 76% to 86%), respectively. The use of meta-analysis in establishing performance characteristics is limited, particularly by the possibility of publication bias (positive results being more likely to be published than negative results) which is difficult to detect especially when based on a limited number of small studies.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies have been performed to evaluate carcinogenic potential, mutagenicity potential, or to determine whether rubidium chloride Rb 82 may affect fertility in males or females.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies have been performed to evaluate carcinogenic potential, mutagenicity potential, or to determine whether rubidium chloride Rb 82 may affect fertility in males or females.
📄 Recent Major Changes ▾
Dosage and Administration, 5/2026 Dosing Using the Infusion System Model 510 ( 2.2 )-Removed Eluate Testing Protocol for Infusion System Model 510 ( 2.6 )-Removed Expiration Limits of CardioGen-82 ( 2.7 )
📄 Package Label / Principal Display Panel ▾
CardioGen-82 NDC: 0270–0091–01 Rubidium Rb 82 Generator Cardiogen Generator Container Label
CardioGen-82 NDC: 0270–0091–01 Rubidium Rb 82 Generator CardioGen Assay Label 46-8200F
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
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) | — 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 | — 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. |