Dextrose
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Dextrose
- Generic name
- DEXTROSE MONOHYDRATE
- Manufacturer
- ProPharma Distribution
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3eff8bcd-6a33-428f-e063-6394a90afa68
- SPL ID
- 3eff8bcd-6a32-428f-e063-6394a90afa68
- Version
- 1
- Effective date
- 2025-09-17
- Source export date
- 2026-09-28
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:05:00
| Harmonized routes |
|---|
| INTRAVENOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 207449 | derived:openfda.application_number |
| application number | ANDA207449 | openfda.application_number | |
| brand name | Dextrose | openfda.brand_name | |
| generic name | DEXTROSE MONOHYDRATE | openfda.generic_name | |
| manufacturer name | ProPharma Distribution | openfda.manufacturer_name | |
| ndc | package | 84549-460-20 | openfda.package_ndc |
| ndc | product | 84549-460 | openfda.product_ndc |
| ndc11 | package | 84549046020 | derived:openfda.package_ndc |
| rxcui | 1795607 | openfda.rxcui | |
| spl id | 3eff8bcd-6a32-428f-e063-6394a90afa68 | id | |
| spl set id | 3eff8bcd-6a33-428f-e063-6394a90afa68 | set_id | |
| unii | LX22YL083G | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.