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Prescription medicine · generic available

Potassium chloride, dextrose monohydrate

Active ingredients: dextrose monohydrate · potassium chloride

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
3Companies
1979First FDA approval on file

Quick answers

What is Potassium chloride, dextrose monohydrate used for?
The FDA-approved label (Potassium Chloride in Dextrose, ICU Medical Inc., October 30, 2025) says: “This solution is indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Potassium chloride, dextrose monohydrate have a boxed warning?
No. None of the 3 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Potassium chloride, dextrose monohydrate?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Potassium chloride, dextrose monohydrate been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Potassium chloride, dextrose monohydrate?
3 companies list prescription products of Potassium chloride, dextrose monohydrate in the FDA NDC Directory, including Fresenius Kabi USA, LLC, ICU Medical Inc. and Baxter Healthcare Company.

What Potassium chloride, dextrose monohydrate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

This solution is indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories.

— FDA label: Potassium Chloride in Dextrose, ICU Medical Inc., effective October 30, 2025. Read the full label on DailyMed →

The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 3 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution
RouteIntravenous
Prescription products4 in the FDA NDC Directory

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA017634
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER		 Baxter HlthcareFebruary 1, 1979 55, latest July 15, 2019
2019: Labeling · 2017: Labeling · 2017: Labeling
NDA018371
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER		 Otsuka Icu MedclMay 29, 1980 62, latest September 8, 2014
2014: Manufacturing (CMC) · 2001: Manufacturing (CMC) · 1999: Labeling

Generic approvals (1)

  • ANDA212346Fresenius Kabi USA · September 10, 2020

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)309783, 2566844
SPL set ID of the quoted label02d694b5-3600-4d55-bd5c-924abaec5315
FDA labels (SPL)3
FDA applicationsNDA017634, NDA018371, 1 ANDA
Active ingredients (FDA)DEXTROSE MONOHYDRATE / POTASSIUM CHLORIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Potassium Chloride in Dextrose, ICU Medical Inc., effective October 30, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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