Dextrose
12500 mg/250mL · Injection, Solution
- Prescription only
- Active substance
- Dextrose Monohydrate
- Made by
- Fresenius Kabi USA, LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-12-17
Not necessarily this product — shortages are reported per presentation. Your pharmacy will know. · Updated 2026-09-22 FDA drug shortages
- Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.
5% Dextrose Injection, USP without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.
From the official label · 2025-12-17 · DailyMed
How it works
From this product’s own US prescribing label.
When administered intravenously, these solutions provide a source of water and carbohydrate.
Isotonic and hypertonic concentrations of dextrose are suitable for parenteral maintenance of water requirements when salt is not needed or should be avoided.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-17
Do not take it if
5% Dextrose Injection, USP without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- The dose is dependent upon the age, weight and clinical condition of the patient.
- As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.
- Drug Interactions Additives may be incompatible.
- Consult with pharmacist, if available.
- When introducing additives, use aseptic technique, mix thoroughly and do not store.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see PRECAUTIONS ).
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Excessive administration of potassium-free solutions may result in significant hypokalemia.
- The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
- The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions.
- The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
- Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
- Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.
- Do not administer unless solution is clear and container is undamaged.
- Discard unused portion.
- Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 5% Dextrose Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
- Pregnancy Teratogenic Effects Pregnancy Category C.
- Nursing Mothers Caution should be exercised when 5% Dextrose Injection, USP is administered to a nursing mother.
- Pediatric Use The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations.
- Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic Effects Pregnancy Category C.
- Animal reproduction studies have not been conducted with dextrose.
- It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Dextrose should be given to a pregnant woman only if clearly needed.
- Caution should be exercised when 5% Dextrose Injection, USP is administered to a nursing mother.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- Additives may be incompatible.
- Consult with pharmacist, if available.
- When introducing additives, use aseptic technique, mix thoroughly and do not store.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see PRECAUTIONS ).
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (see WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS ).
Quoted from the official label, section “Overdosage”.
Use in children
- The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations.
- In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
- Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.
- In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolarity and possible intracerebral hemorrhage.
Quoted from the official label, section “Pediatric Use”.
Use in older people
- An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients.
- In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Quoted from the official label, section “Geriatric Use”.
Side effects
- Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
- If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
- To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- 5% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows:
- Product Code Unit of Sale Strength Each 252300 NDC 65219-234-10 Package of 60 free flex ® + bags 2.5 grams per 50 mL (50 mg per mL) NDC 65219-234-01 50 mL in a 100 mL free flex ® + bag 262300 NDC 65219-236-10 Package of 50 free flex ® + bags 5 grams per 100 mL (50 mg per mL) NDC 65219-236-01 100 mL free flex ® + bag 262325 NDC 65219-238-25 Package of 30 free flex ® + bags 12.5 grams per 250 mL (50 mg per mL) NDC 65219-238-01 250 mL free flex ® + bag 262450 NDC 65219-240-50 Package of 20 free flex ® + bags 25 grams per 500 mL (50 mg per mL) NDC 65219-240-01 500 mL free flex ® + bag
- Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- Exposure of pharmaceutical products to heat should be minimized.
- Avoid excessive heat.
- Protect from freezing.
- The container closure is not made with natural rubber latex.
- Non-PVC, Non-DEHP, Sterile.
- Lake Zurich, IL 60047 www.fresenius-kabi.com/us Revised: August 2024 Figure
Quoted from the official label, section “How Supplied”.
What is in it
- 5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6
- H 2 O), a hexose sugar freely soluble in water. It has the following structural formula:
- Water for Injection, USP is chemically designated H 2 O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The free flex ® + bag has a needle-free injection port and can accept standard luer lock syringes to add medication. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. Structural Formula
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | Fresenius Kabi USA, LLC |
|---|---|
| Active substance | Dextrose Monohydrate |
| Strength | 12500 mg/250mL |
| Form | Injection, Solution |
| Route | Intravenous |
| Packs | 30 BAG in 1 CASE / 250 mL in 1 BAG |
| NDC | 65219-238 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
42 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Injection, Solution34 products
- 2.5 g/50mL
5 g/100mL2
5 g/100mL · 2 companies
- 10 g/100mL
- 20 g/100mL
- 30 g/100mL
- 40 g/100mL
50 mg/mL5
- 50 g/1000mL
- 50 g/100mL
70 g/100mL2
70 g/100mL · 2 companies
- 100 g/1000mL
100 mg/mL3
100 mg/mL · 3 companies
250 mg/mL3
250 mg/mL · 3 companies
2500 mg/50mL2
2500 mg/50mL · 2 companies
- 5000 mg/100mL
- 12500 mg/250mL
- 25000 mg/500mL
- Injection4 products
2.5 g/50mL2
2.5 g/50mL · 2 companies
5 g/100mL2
5 g/100mL · 2 companies
- Solution3 products
- Injection, Solution, Concentrate1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.