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Dextrose Monohydrate: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current since November 3, 2026
Strength:
2500 mg/50 mL, 5000 mg/100 mL, 12500 mg/250 mL, 25000 mg/500 mL
Active ingredient:
Similar drugs:

Patient information: uses, side effects, how to take - Dextrose Monohydrate

INSTRUCTIONS FOR USE:

Check flexible container solution composition, lot number, and expiry date.

Do not remove solution container from its overwrap until immediately before use.

Use sterile equipment and aseptic technique.

To Open

  1. 1. Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container.
  2. 2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
  3. 3. Do not use if the solution is cloudy or a precipitate is present.

To Add Medication

The Additive port of the free flex ® + container accepts standard luer lock syringes. Do not use a needle for additions.

  1. 1. Identify LIGHT BLUE Additive Port with arrow pointing toward solution container.
  2. 2. Immediately before injecting additives, break off LIGHT BLUE Additive Port Cap with the arrow pointing toward solution container.
  3. 3. Hold base of LIGHT BLUE Additive Port.
  4. 4. Attach Luer Lock syringe to the threaded LIGHT BLUE Additive Port. Inject additive.
  5. 5. Mix solution container contents thoroughly.

Preparation for Administration

  1. 1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
  2. 2. Use a non-vented infusion set or close the air-inlet on a vented set.
  3. 3. Close the roller clamp of the infusion set.
  4. 4. Hold the base of BLUE Infusion Port.
  5. 5. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted.

NOTE: See full directions accompanying administration set.

WARNING: Do not use flexible container in series connections.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 207449 · View the label on DailyMed

Revision date stated in the text: August 2024

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Dextrose Monohydrate

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Dextrose monohydrate
Dosage form Injection, solution
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) FRESENIUS KABI USA
FDA approval ANDA 207449Abbreviated New Drug Application (ANDA) – generic drug Approved October 21, 2016
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 11 labelers list this drug on DailyMed
Drug shortage
  • Current since November 3, 2026
Recalls
  • April 2, 2026: Class II recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
  • March 11, 2026: Class II recall: Lack of Assurance of Sterility
  • March 11, 2026: Class II recall: Lack of Assurance of Sterility
Show more recalls (1)+
  • March 11, 2026: Class II recall: Lack of Assurance of Sterility
Packages (NDC)
Package
2500 mg/50 mL – 50 ml in 1 bag / 60 in 1 case NDC 65219-234-01
5000 mg/100 mL – 100 ml in 1 bag / 50 in 1 case NDC 65219-236-01
12500 mg/250 mL – 250 ml in 1 bag / 30 in 1 case NDC 65219-238-01
25000 mg/500 mL – 500 ml in 1 bag / 20 in 1 case NDC 65219-240-01

Source: FDA drug labeling via NLM DailyMed, data as of November 5, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.