Quick answers
- What is CardioGen-82?
- CardioGen-82 is a brand name of Rubidium chloride RB-82, a prescription medicine. The FDA NDC Directory lists 1 CardioGen-82 product in 1 strength and form.
- Who makes CardioGen-82?
- Bracco holds the FDA application for CardioGen-82 (NDA019414, approved December 29, 1989).
- Is there a generic or store brand of CardioGen-82?
- Other products of Rubidium chloride RB-82 are listed with the FDA, but none in exactly the same strength and form as a CardioGen-82 product.
- Has CardioGen-82 been recalled?
- FDA enforcement reports list 1 recall of CardioGen-82 products; the newest started June 1, 2012. A recall usually concerns specific lots, not every product.
What CardioGen-82 is
Each CardioGen-82 product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Rubidium chloride RB-82 · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| rubidium chloride RB-82 150 mCi injection, solution (intravenous) | CardioGen-82 | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Rubidium chloride RB-82 →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019414 | Bracco | December 29, 1989 | 1 |
Companies that list CardioGen-82
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of CardioGen-82 products.
- Bracco Diagnostics Inc1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 1, 2012 · Class II · Terminated · D-1684-2012
GMP deviation; Sr-82 levels exceeded alert limit specification
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Pla — Bracco Diagnostics Inc
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.