Normosol-R
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
- Normosol-R
- Generic name
- SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
- Manufacturer
- ICU Medical Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 189b8ac6-e346-454f-b501-7645590ca4f8
- SPL ID
- 0cc8e6a8-fdbd-4738-bdea-d26c19b24d87
- Version
- 11
- Effective date
- 2025-10-29
- 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 05:26:33
| 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 | NDA | 017586 | derived:openfda.application_number |
| application number | NDA017586 | openfda.application_number | |
| brand name | Normosol-R | openfda.brand_name | |
| generic name | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | openfda.generic_name | |
| manufacturer name | ICU Medical Inc. | openfda.manufacturer_name | |
| ndc | package | 0990-7967-09 | openfda.package_ndc |
| ndc | product | 0990-7967 | openfda.product_ndc |
| ndc11 | package | 00990796709 | derived:openfda.package_ndc |
| rxcui | 800985 | openfda.rxcui | |
| rxcui | 800988 | openfda.rxcui | |
| spl id | 0cc8e6a8-fdbd-4738-bdea-d26c19b24d87 | id | |
| spl set id | 189b8ac6-e346-454f-b501-7645590ca4f8 | set_id | |
| unii | 02F3473H9O | openfda.unii | |
| unii | R6Q3791S76 | openfda.unii | |
| unii | 451W47IQ8X | openfda.unii | |
| unii | NVG71ZZ7P0 | openfda.unii | |
| unii | 660YQ98I10 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function during fluid replacement with Normosol-R. Solutions containing acetate or gluconate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate or gluconate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency. The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Elderly patients may be at increased risk for the development of fluid overloading and dilutional hyponatremia following Normosol-R administration. 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.