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
- Manufacturer
- HF Acquisition Co. LLC. DBA HealthFirst
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 4d2d3d3d-d96e-4005-e063-6394a90afd9a
- SPL ID
- 4d2d3d3d-d96f-4005-e063-6394a90afd9a
- Version
- 1
- Effective date
- 2026-03-16
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:27:20
| 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 | 209448 | derived:openfda.application_number |
| application number | ANDA209448 | openfda.application_number | |
| brand name | DEXTROSE | openfda.brand_name | |
| generic name | DEXTROSE | openfda.generic_name | |
| manufacturer name | HF Acquisition Co. LLC. DBA HealthFirst | openfda.manufacturer_name | |
| ndc | package | 51662-1680-1 | openfda.package_ndc |
| ndc | product | 51662-1680 | openfda.product_ndc |
| ndc11 | package | 51662168001 | derived:openfda.package_ndc |
| rxcui | 1795480 | openfda.rxcui | |
| spl id | 4d2d3d3d-d96f-4005-e063-6394a90afd9a | id | |
| spl set id | 4d2d3d3d-d96e-4005-e063-6394a90afd9a | set_id | |
| unii | LX22YL083G | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Hyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood glucose and administer insulin as needed. (5.1) Hypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion if reactions occur. (5.2) Vein Damage and Thrombosis: Consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain. (2.2, 5.3) Hyponatremia: Avoid in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. (5.4) Electrolyte Imbalance and Fluid Overload: Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance, electrolyte concentrations, and acidbase balance, as needed and especially during prolonged use. (5.5) Refeeding Syndrome: Monitor severely undernourished patients and slowly increase nutrient intake. (5.6)
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
The most common adverse reactions are, hyperglycemia, hypersensitivity reactions, hyponatremia, infection both systemic and at the injection site, vein thrombosis or phlebitis, and electrolyte imbalance. (6) 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.