Skip to main content
PlainMeds

Prescription medicine

Dextrose and sodium chloride

Dextrose and sodium chloride is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 2 generic labelers.

  • Generic listed

Check it at the source: the dextrose and sodium chloride FDA label on DailyMed (effective November 2, 2025, ICU Medical Inc.); the NDA 16689 record on Drugs@FDA; every dextrose and sodium chloride label on DailyMed.

Highlights of the record

FDA label of November 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.

Forms and strengths

  • 2.5 g/100ml / 0.45 g/100ml
  • 2.5 g/100ml / 450 mg/100ml
  • 3.3 g/100ml / 0.3 g/100ml
  • 5 g/100ml / 0.9 g/100ml
  • 5 g/100ml / 0.45 g/100ml
  • 5 g/100ml / 0.225 g/100ml
  • 5 g/100ml / 0.3 g/100ml
  • 5 g/100ml / 450 mg/100ml
  • 5 g/100ml / 200 mg/100ml
  • 5 g/100ml / 0.33 g/100ml
  • 5 g/100ml / 0.2 g/100ml
  • 5 g/100ml / 900 mg/100ml

Injection (solution).

On the market

Earliest approval on file
December 8, 1970 Dextrose 5% In Sodium Chloride 0.2% In Plastic Container, Baxter Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
5 first December 20, 2019; 5 with a marketed status in Drugs@FDA
Labelers listed (NDC)
5 of which 2 under generic applications, 3 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
FAERS reports
165 through July 30, 2026

What is dextrose and sodium chloride used for?

From the label: indications and usage

Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.

FDA pharmacologic class: Osmotic Laxative.

Source: FDA drug label (Dextrose and Sodium Chloride), NDA017606 (Otsuka Icu Medcl), as published by ICU Medical Inc., effective November 2, 2025 (SPL set 4555b1bf-6d97-4798-a63d-6d34291c85ce), via openFDA; the full label on DailyMed

Is there a generic for dextrose and sodium chloride?

The FDA approved the first generic dextrose and sodium chloride on December 20, 2019. 5 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists dextrose and sodium chloride from 2 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

  • 1970 earliest approval on file
  • 2019 first generic approved

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

What does the dextrose and sodium chloride label say about other medicines?

The dextrose and sodium chloride label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Corticotropinwarnings and precautionsMedications such as corticosteroids or corticotropin, may increase the risk of sodium and fluid retention. Avoid in patients with or at risk for hypernatremia.
Lithiumdrug interactionsDecreased lithium concentrations with concomitant use; monitor serum lithium concentrations.
Thiaminewarnings and precautionsThiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increasing nutrient intake.

Check dextrose and sodium chloride against other medicines

Source: FDA drug label (Dextrose and Sodium Chloride), NDA017606 (Otsuka Icu Medcl), as published by ICU Medical Inc., effective November 2, 2025 (SPL set 4555b1bf-6d97-4798-a63d-6d34291c85ce), via openFDA; the full label on DailyMed

What do FAERS reports show for dextrose and sodium chloride?

The FDA Adverse Event Reporting System holds 165 reports that list dextrose and sodium chloride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 107 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Vomiting39
  • Nausea33
  • Hyponatraemia27
  • Ascites26
  • Constipation26
  • Sepsis26
  • Abdominal Distension25
  • Abdominal Pain25

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other osmotic laxatives
the pharmacologic class, with prices and generics
Dextrose and sodium chloride side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other