Quick answers
- What is Cardiolite?
- Cardiolite is a brand name of TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate, a prescription medicine. The FDA NDC Directory lists 2 Cardiolite products in 1 strength and form.
- Who makes Cardiolite?
- Shine holds the FDA application for Cardiolite (NDA019785, approved December 21, 1990). 1 other company (repackagers or distributors) also list Cardiolite products.
- Is there a generic or store brand of Cardiolite?
- Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Cardiolite product. Ask your pharmacist whether one is right for you.
- Has Cardiolite been recalled?
- No recall linked to Cardiolite products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Cardiolite is
Each Cardiolite 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.
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate 1 mg/mL injection, powder, lyophilized, for solution (intravenous) | Cardiolite | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019785 | Shine | December 21, 1990 | 2 |
Companies that list Cardiolite
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Cardiolite products.
- Shine Spect USA, LLC1 product
- Lantheus Medical Imaging, Inc.1 product
Recalls
No recall linked to Cardiolite products (by their NDC code or label) appears in the FDA enforcement reports.
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.