Quick answers
- What is Normosol-R?
- Normosol-R is a brand name of Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride, a prescription medicine. The FDA NDC Directory lists 2 Normosol-R products in 1 strength and form.
- Who makes Normosol-R?
- Otsuka ICU Medcl holds the FDA application for Normosol-R (NDA017586, approved August 13, 1975).
- Is there a generic or store brand of Normosol-R?
- Other products of Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride are listed with the FDA, but none in exactly the same strength and form as a Normosol-R product.
- Has Normosol-R been recalled?
- No recall linked to Normosol-R products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Normosol-R is
Each Normosol-R 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.
Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| magnesium chloride 30 mg/100 mL · potassium chloride 37 mg/100 mL · sodium acetate anhydrous 222 mg/100 mL · sodium chloride 526 mg/100 mL · sodium gluconate 502 mg/100 mL injection, solution (intravenous) | Normosol-R | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA017586 | Otsuka ICU Medcl | August 13, 1975 | 2 |
Companies that list Normosol-R
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Normosol-R products.
- ICU Medical Inc.2 products
Recalls
No recall linked to Normosol-R 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.