Quick answers
- What is Nexterone?
- Nexterone is a brand name of Amiodarone hydrochloride, a prescription medicine. The FDA NDC Directory lists 2 Nexterone products in 2 strengths and forms.
- Who makes Nexterone?
- Baxter Hlthcare holds the FDA application for Nexterone (NDA022325, approved December 24, 2008).
- Is there a generic or store brand of Nexterone?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Nexterone product. Ask your pharmacist whether one is right for you.
- Has Nexterone been recalled?
- FDA enforcement reports list 2 recalls of Nexterone products; the newest started August 6, 2026. A recall usually concerns specific lots, not every product.
What Nexterone is
Each Nexterone 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 1.5 mg/mL injection, solution (intravenous) | Nexterone | 1 product, 1 company | DailyMed |
| amiodarone hydrochloride 1.8 mg/mL injection, solution (intravenous) | Nexterone | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Amiodarone hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022325 | Baxter Hlthcare | December 24, 2008 | 2 |
Companies that list Nexterone
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Nexterone products.
- Baxter Healthcare Corporation2 products
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 6, 2026 · Class II · Ongoing · D-0814-2026
CGMP Deviations
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 430 — Baxter Healthcare Corporation
-
November 10, 2017 · Class I · Terminated · D-0573-2018
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10 — Baxter Healthcare Corporation
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.