Prescription medicine

Dextrose, magnesium chloride and 4 other ingredients

Dextrose, magnesium chloride and 4 other ingredients is a prescription medicine with an FDA approval on record since 1975. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the dextrose, magnesium chloride and 4 other ingredients FDA label on DailyMed (effective October 30, 2025, ICU Medical Inc.); the NDA 17609 record on Drugs@FDA; every dextrose, magnesium chloride and 4 other ingredients label on DailyMed.

Highlights of the record

FDA label of October 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Normosol-R and 5% Dextrose Injection is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock.

Forms and strengths

5 g/100ml / 526 mg/100ml / 222 mg/100ml / 502 mg/100ml / 37 mg/100ml / 30 mg/100ml

Injection (solution).

On the market

Earliest approval on file: August 13, 1975 Normosol-R And Dextrose 5% In Plastic Container, Otsuka Icu Medcl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is dextrose, magnesium chloride and 4 other ingredients used for?

From the label: indications and usage
Normosol-R and 5% Dextrose Injection is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R and 5% Dextrose also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. The solution is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume.

FDA pharmacologic class: Calculi Dissolution Agent, Osmotic Laxative and Potassium Salt.

Source: FDA drug label (Normosol-R and Dextrose), NDA017609 (Otsuka Icu Medcl), as published by ICU Medical Inc., effective October 30, 2025 (SPL set ead1fca3-eff4-478f-8a8f-67510f80151a), via openFDA; the full label on DailyMed

Is there a generic for dextrose, magnesium chloride and 4 other ingredients?

No generic dextrose, magnesium chloride and 4 other ingredients is approved (Drugs@FDA, October 8, 2026).

1975 earliest approval on file

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What next?

Other calculi dissolution agents: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other