Quick answers
- What is Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate used for?
- The FDA-approved label (Lactated Ringers and Dextrose, ICU Medical Inc., November 2, 2025) says: “These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate?
- 5 companies list prescription products of Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Baxter Healthcare Corporation and ICU Medical Inc..
What Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.
— FDA label: Lactated Ringers and Dextrose, ICU Medical Inc., effective November 2, 2025. Read the full label on DailyMed →
The FDA has 8 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 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 9 in the FDA NDC Directory |
| Brand names | Lactated Ringers and Dextrose, Potassium Chloride in Lactated Ringers and Dextrose, Dextrose in Lactated Ringers |
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.
- Fresenius Kabi USA, LLC3 products
- Baxter Healthcare Corporation2 products
- ICU Medical Inc.2 products
- HF Acquisition Co LLC, DBA HealthFirst1 product
- B. Braun Medical Inc.1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016679 LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER | Baxter Hlthcare | March 22, 1971 | 79, latest November 5, 2025 2025: Labeling · 2019: Labeling · 2017: Labeling |
| NDA017608 DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | Otsuka Icu Medcl | August 13, 1975 | 105, latest December 24, 2015 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA019367 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | Baxter Hlthcare | April 5, 1985 | 21, latest November 5, 2025 2025: Labeling · 2019: Labeling · 2017: Labeling |
| NDA019634 DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER, DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER | B Braun | February 24, 1988 | 22, latest November 5, 2025 2025: Labeling · 2021: Labeling · 2014: Manufacturing (CMC) |
| NDA019685 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | Otsuka Icu Medcl | October 17, 1988 | 13, latest September 8, 2014 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2001: Manufacturing (CMC) |
Generic approvals (2)
- ANDA211428Fresenius Kabi USA · November 9, 2021
- ANDA210332Fresenius Kabi USA · March 28, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 847626, 847627, 847630 |
|---|---|
| SPL set ID of the quoted label | d310d170-5eeb-471b-af1a-0e845001d21d |
| FDA labels (SPL) | 8 |
| FDA applications | NDA016679, NDA017608, NDA019367, NDA019634, NDA019685, 2 ANDA |
| Active ingredients (FDA) | CALCIUM CHLORIDE / DEXTROSE MONOHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM LACTATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lactated Ringers and Dextrose, ICU Medical Inc., effective November 2, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →