Quick answers
- What is Dextrose monohydrate and sodium chloride used for?
- The FDA-approved label (Dextrose and Sodium Chloride, ICU Medical Inc., November 2, 2025) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dextrose monohydrate and sodium chloride have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dextrose monohydrate and sodium chloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dextrose monohydrate and sodium chloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dextrose monohydrate and sodium chloride?
- 4 companies list prescription products of Dextrose monohydrate and sodium chloride in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Baxter Healthcare Company and ICU Medical Inc..
What Dextrose monohydrate and sodium chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 label: Dextrose and Sodium Chloride, ICU Medical Inc., effective November 2, 2025. Read the full label on DailyMed →
The FDA has 9 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 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 15 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.
- Fresenius Kabi USA, LLC5 products
- Baxter Healthcare Company4 products
- ICU Medical Inc.4 products
- Becton Dickinson and Company2 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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016678 DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter Hlthcare | December 9, 1970 | 75, latest August 22, 2019 2019: Labeling · 2015: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA016683 DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Baxter Hlthcare | March 22, 1971 | 72, latest August 22, 2019 2019: Labeling · 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
| NDA016689 DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | Baxter Hlthcare | December 8, 1970 | 74, latest August 22, 2019 2019: Labeling · 2014: Manufacturing (CMC) · 2013: Labeling |
| NDA016697 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Baxter Hlthcare | March 22, 1971 | 70, latest August 22, 2019 2019: Labeling · 2014: Manufacturing (CMC) · 2013: Labeling |
| NDA017585 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Otsuka Icu Medcl | January 7, 1976 | 104, latest July 31, 2015 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2002: Labeling |
| NDA017606 DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | Otsuka Icu Medcl | August 13, 1975 | 102, latest September 5, 2013 2013: Manufacturing (CMC) · 2000: Labeling · 1998: Manufacturing (CMC) |
| NDA017607 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Otsuka Icu Medcl | August 13, 1975 | 104, latest September 8, 2014 2014: Manufacturing (CMC) · 2006: Labeling · 2002: Labeling |
| NDA017799 DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | Otsuka Icu Medcl | April 12, 1977 | 95, latest September 5, 2013 2013: Manufacturing (CMC) · 2002: Manufacturing (CMC) · 2000: Labeling |
Generic approvals (5)
- ANDA211190Fresenius Kabi USA · December 20, 2019
- ANDA211194Fresenius Kabi USA · August 26, 2020
- ANDA211211Fresenius Kabi USA · September 14, 2020
- ANDA211221Fresenius Kabi USA · September 15, 2020
- ANDA211276Fresenius Kabi USA · September 15, 2020
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) | 1794881, 1794886, 1794887, 1794902, 1794904, 1794905, 1795147, 1795149, 1795150, 1795250 … (+5) |
|---|---|
| SPL set ID of the quoted label | 4555b1bf-6d97-4798-a63d-6d34291c85ce |
| FDA labels (SPL) | 9 |
| FDA applications | NDA016678, NDA016683, NDA016689, NDA016697, NDA017585, NDA017606, NDA017607, NDA017799, 5 ANDA |
| Active ingredients (FDA) | DEXTROSE MONOHYDRATE / SODIUM CHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dextrose and Sodium Chloride, 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 →