Quick answers
- What is Technetium Tc 99m Sestamibi?
- Technetium Tc 99m Sestamibi is a brand name of TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate, a prescription medicine. The FDA NDC Directory lists 1 Technetium Tc 99m Sestamibi product in 1 strength and form.
- Who makes Technetium Tc 99m Sestamibi?
- Curium holds the FDA application for Technetium Tc 99m Sestamibi (ANDA078098, approved September 22, 2008).
- Is there a generic or store brand of Technetium Tc 99m Sestamibi?
- Other products of TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate are listed with the FDA, but none in exactly the same strength and form as a Technetium Tc 99m Sestamibi product.
- Has Technetium Tc 99m Sestamibi been recalled?
- FDA enforcement reports list 1 recall of Technetium Tc 99m Sestamibi products; the newest started November 26, 2024. A recall usually concerns specific lots, not every product.
What Technetium Tc 99m Sestamibi is
Each Technetium Tc 99m Sestamibi 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 (intravenous) | Technetium Tc 99m Sestamibi | None listed | 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
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA078098 | Curium | September 22, 2008 | 1 |
Companies that list Technetium Tc 99m Sestamibi
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Technetium Tc 99m Sestamibi products.
- Curium US LLC1 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.
-
November 26, 2024 · Class II · Terminated · D-0164-2025
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 m — Curium US, LLC
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.