TPN Electrolytes
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
- TPN Electrolytes
- Generic name
- SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUS
- Manufacturer
- Hospira, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- c00817bc-7b62-4abe-0280-e7930eda3f94
- SPL ID
- 298a40da-5753-4431-bf48-5ed505d8d3d7
- Version
- 20
- Effective date
- 2026-05-25
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:59:52
| 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 | 018895 | derived:openfda.application_number |
| application number | NDA018895 | openfda.application_number | |
| brand name | TPN Electrolytes | openfda.brand_name | |
| generic name | SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUS | openfda.generic_name | |
| manufacturer name | Hospira, Inc. | openfda.manufacturer_name | |
| ndc | package | 0409-5779-01 | openfda.package_ndc |
| ndc | package | 0409-5779-11 | openfda.package_ndc |
| ndc | product | 0409-5779 | openfda.product_ndc |
| ndc11 | package | 00409577901 | derived:openfda.package_ndc |
| ndc11 | package | 00409577911 | derived:openfda.package_ndc |
| rxcui | 801451 | openfda.rxcui | |
| spl id | 298a40da-5753-4431-bf48-5ed505d8d3d7 | id | |
| spl set id | c00817bc-7b62-4abe-0280-e7930eda3f94 | set_id | |
| unii | 02F3473H9O | openfda.unii | |
| unii | 451W47IQ8X | openfda.unii | |
| unii | NVG71ZZ7P0 | openfda.unii | |
| unii | 660YQ98I10 | openfda.unii | |
| unii | M4I0D6VV5M | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS CONCENTRATED, HYPERTONIC, ADDITIVE SOLUTION. Must be diluted in TPN solution prior to administration. CONTAINS NO PHOSPHATE. Patients receiving TPN solutions containing concentrated dextrose require additive phosphate, in addition to TPN Electrolytes. Between 10 and 15 mM (310 to 465 mg) phosphorus are physically compatible with as much as 10 to 12 mEq calcium in the same admixture. The phosphate supplement should first be added to the amino acid or dextrose bottle and diluted well to avoid precipitation with calcium. CONTAINS 20 mEq of POTASSIUM. The potassium content of other additives, such as potassium phosphate or potassium-containing antibiotics, must be considered in the context of total potassium delivered. TPN patients usually require 30 to 50 mEq of potassium per liter of TPN solution containing concentrated (20—25%) dextrose. NOT INTENDED FOR PEDIATRIC USE. 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 ions 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. Solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. Warning: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Symptoms may result from an excess or deficit of one or more of the ions present in TPN Electrolytes. Therefore, frequent monitoring of electrolyte blood levels is recommended. Sodium excess can cause edema and exacerbation of congestive heart failure. Excess potassium can cause deviations from the normal ECG (electrocardiogram). Potassium deficits can impair neuromuscular function, causing muscle weakness or frank paralysis, intestinal dilatation and ileus. Calcium deficits can produce neuromuscular hyperexcitability, ranging from paresthesias, cramps and laryngospasm to tetany and grand mal seizures. Depressed calcium levels can accompany administration of parenteral phosphorous or large amounts of albumin. Magnesium deficiency can precipitate neuromuscular dysfunction, hyperirritability, psychotic behavior, tachycardia and hypertension. Magnesium excess can cause muscle weakness, ECG changes, sedation and mental confusion.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.