Quick answers
- What is Choletec?
- Choletec is a brand name of Kit for the preparation of technetium tc 99M mebrofenin, a prescription medicine. The FDA NDC Directory lists 1 Choletec product in 1 strength and form.
- Who makes Choletec?
- Bracco holds the FDA application for Choletec (NDA018963, approved January 21, 1987).
- Is there a generic or store brand of Choletec?
- Other products of Kit for the preparation of technetium tc 99M mebrofenin are listed with the FDA, but none in exactly the same strength and form as a Choletec product.
- Has Choletec been recalled?
- FDA enforcement reports list 1 recall of Choletec products; the newest started August 14, 2012. A recall usually concerns specific lots, not every product.
What Choletec is
Each Choletec 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.
Kit for the preparation of technetium tc 99M mebrofenin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| mebrofenin 45 mg injection, powder, lyophilized, for solution (intravenous) | Choletec | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Kit for the preparation of technetium tc 99M mebrofenin →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA018963 | Bracco | January 21, 1987 | 1 |
Companies that list Choletec
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Choletec 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.
-
August 14, 2012 · Class III · Terminated · D-095-2013
Presence of Particulate Matter; potential for charcoal particulates
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, — Bracco Diagnostic 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.