Prescription medicine

Rubidium chloride rb 82 Brand names: Ruby-Fill; first approved as Cardiogen-82

Rubidium chloride rb 82 (Cardiogen-82) is a prescription medicine with an FDA approval on record since 1989. No generic is listed in FDA's NDC Directory.

No generic listed
Boxed warning

Check it at the source: the rubidium chloride rb 82 FDA label on DailyMed (effective May 14, 2026, Bracco Diagnostics Inc); the NDA 19414 record on Drugs@FDA; every rubidium chloride rb 82 label on DailyMed.

Highlights of the record

FDA label of May 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed 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. […]

Used for

From the label: 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.

Forms and strengths

Injection (solution).

On the market

Earliest approval on file: December 29, 1989 Cardiogen-82, Bracco; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 2 of which 0 under generic applications, 2 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): 1 since 2012 0 Class I among all firms' recalls; latest June 1, 2012
FAERS reports: 130 through July 30, 2026

What is rubidium chloride rb 82 used for?

From the label: 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.

FDA pharmacologic class: Radioactive Diagnostic Agent.

Source: FDA drug label (CardioGen-82), Bracco Diagnostics Inc, effective May 14, 2026 (SPL set ee95aa18-9f2f-40eb-9b4c-583bea6f36bf), via openFDA; the full label on DailyMed

Is there a generic for rubidium chloride rb 82 (Cardiogen-82)?

No generic rubidium chloride rb 82 is approved (Drugs@FDA, October 8, 2026).

1989 earliest approval on file
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has rubidium chloride rb 82 been recalled?

The FDA's Enforcement Report lists 1 recall naming rubidium chloride rb 82 since 2012: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
June 1, 2012	Class II	Bracco Diagnostics Inc	GMP deviation; Sr-82 levels exceeded alert limit specification

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What do FAERS reports show for rubidium chloride rb 82?

The FDA Adverse Event Reporting System holds 130 reports that list rubidium chloride rb 82 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 2 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

No Adverse Event (a use or a product term, not a reaction)76
Expired Product Administered (a use or a product term, not a reaction)26
Product Preparation Error26
Wrong Technique In Product Usage Process (a use or a product term, not a reaction)23
Drug Ineffective (a use or a product term, not a reaction)11
Radiation Overdose (a use or a product term, not a reaction)8
Underdose (a use or a product term, not a reaction)7
Off Label Use (a use or a product term, not a reaction)6

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other radioactive diagnostic agents: the pharmacologic class, with prices and generics
Rubidium chloride rb 82 side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other