Quick answers
- What is Amiodarone Hci?
- Amiodarone Hci is a brand name of Amiodarone hydrochloride, a prescription medicine. The FDA NDC Directory lists 1 Amiodarone Hci product in 1 strength and form.
- Who makes Amiodarone Hci?
- Fresenius Kabi USA holds the FDA application for Amiodarone Hci (ANDA075761, approved October 15, 2002).
- Is there a generic or store brand of Amiodarone Hci?
- Yes. The FDA NDC Directory lists 20 other products with the same active ingredients, strength and form as a Amiodarone Hci product, 20 of them generic. Ask your pharmacist whether one is right for you.
- Has Amiodarone Hci been recalled?
- No recall linked to Amiodarone Hci products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Amiodarone Hci is
Each Amiodarone Hci 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.
Amiodarone hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| amiodarone hydrochloride 50 mg/mL injection, solution (intravenous) | Amiodarone Hci | 20 products, 11 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Amiodarone hydrochloride →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA075761 | Fresenius Kabi USA | October 15, 2002 | 1 |
Companies that list Amiodarone Hci
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Amiodarone Hci products.
Recalls
No recall linked to Amiodarone Hci 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.