Plasma-Lyte A Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution, 500 mL — NDC 0338-0221-03 (Billing 00338-0221-03)
This is a package of 500 mL of Plasma-Lyte A Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution from Baxter Healthcare Corporation, marketed since Feb 1979 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0338-0221-03 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0338 labeler · 0221 product · 03 package
- Package marketed since
- Feb 2, 1979
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 500 mL per package
- Barcode (UPC-A, from the NDC)
- 3 0338022103 5
- Medicaid fills, this package
- 6,349 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 001447
- GCN: 04290
- HICL (First Databank): 000618
- AHFS class code: 40:12.00.00
- RxCUI (RxNorm): 801109
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Electrolyte solutions class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- The IV versions replace water and electrolytes and help balance acid levels. Normosol-R is also used for fluid loss in surgery, trauma, burns or shock. Physiolyte is different: it...
- The IV products are given by healthcare staff through a vein with sterile equipment. Your team decides the amount and speed based on your age, weight and condition. Normosol-R may...
- You might get irritation, infection or a clot near the IV site, or a fever. Too much fluid can also occur. Tell your nurse about any pain or swelling at the site.
- Tell your care team right away about chest pain, trouble breathing, a racing heartbeat, flushing, confusion, seizures, severe weakness or swelling. These could be allergic reaction...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.0308 | $15.40 / 500 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.0170 | $8.50 / 500 ml |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00338-0221-03 You're viewing this Main listing | 500 mL in 1 BAG | 1979-02-02 | — | Active |
| 00338-0221-04 0338-0221-04 | 1000 mL in 1 BAG | 1979-02-02 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 77% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00338-0221-04?
What NDC number is used to bill for this package of Plasma-Lyte A Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Plasma-Lyte A 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mLthis 00338-0221-03 | Baxter | 500 ml | — | — | FDA listed | — |
| Plasma-Lyte 148 (pH 7.4) 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL 00338-9593-10 | Baxter | 1000 ml | — | — | FDA listed | — |
| Multiple Electrolytes pH 5.5 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL 65219-0387-05 | Fresenius | 500 ml | — | — | FDA listed | — |
| Multiple Electrolytes pH 7.4 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL 65219-0389-05 | Fresenius | 500 ml | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Baxter Healthcare Corporation labeler code 00338
- CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose 584 mg/100mL; 448 mg/100mL; 464 mg/100mL; 320 mg/100mL; 480 mg/100mL; 464 mg/100mL; 384 mg/100mL; 336 mg/100mL; 144 mg/100mL; 1656 mg/100mL; 824 mg/10 Injection NDC 0338-0206-04
- Dextrose 5 g/100mL Injection NDC 0338-0208-04
- CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose 584 mg/100mL; 448 mg/100mL; 464 mg/100mL; 320 mg/100mL; 480 mg/100mL; 464 mg/100mL; 384 mg/100mL; 336 mg/100mL; 144 mg/100mL; 1656 mg/100mL; 824 mg/10 Injection NDC 0338-0210-06
- Dextrose 2.5 g/50mL Injection NDC 0338-0211-04
- CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose 584 mg/100mL; 448 mg/100mL; 464 mg/100mL; 320 mg/100mL; 480 mg/100mL; 464 mg/100mL; 384 mg/100mL; 336 mg/100mL; 144 mg/100mL; 1656 mg/100mL; 824 mg/10 Injection NDC 0338-0214-04
- Dextrose 5 g/100mL Injection NDC 0338-0216-04
- Glycine 1.5 g/100mL Solution NDC 0338-0289-47
- Sorbitol 30 g/1000mL Irrigant NDC 0338-0295-47
- RECOTHROM thrombin topical recombinant Kit NDC 0338-0322-01
- RECOTHROM thrombin topical recombinant Kit NDC 0338-0326-01
- RECOTHROM thrombin topical recombinant Kit NDC 0338-0330-01
- Cardioplegic Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium 17.6 mg/100mL; 325.3 mg/100mL; 119.3 mg/100mL; 643 mg/100mL Solution NDC 0338-0341-04
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Important Administration Instructions • PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is intended for intravenous administration using sterile equipment. • Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. • Use a dedicated line without any connections to avoid air embolism. • Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. • Prior to infusion, visually inspect the solution for particulate matter and discoloration.
The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged. • PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is compatible with blood or blood components. It may be administered prior to or following the infusion of blood through the same administration set (i.e., as a priming solution), added to or infused concurrently with blood components, or used as a diluent in the transfusion of packed erythrocytes.
PLASMA-LYTE A Injection and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components. Dosing Information The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. Introduction of Additives Additives may be incompatible.
Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique.
Mix thoroughly when additives have been introduced. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives.
Discard any unused portion.
⛔ Contraindications ▾
CONTRAINDICATIONS PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is contraindicated in patients with a known hypersensitivity to the product. See WARNINGS .
⚠️ Warnings ▾
WARNINGS Hypersensitivity Reactions Hypersensitivity and infusion reactions have been reported with PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). See ADVERSE REACTIONS . Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing.
Appropriate therapeutic countermeasures must be instituted as clinically indicated. Electrolyte Imbalances Fluid Overload Depending on the volume and rate of infusion, the intravenous administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause electrolyte disturbances such as overhydration, and congested states, including pulmonary congestion and edema. Avoid PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with or at risk for fluid and/or solute overloading.
If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use. Hyponatremia PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting.
Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of hypotonic PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). Avoid PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in hypervolemic or overhydrated patients.
If use cannot be avoided, monitor serum sodium concentrations. Hypernatremia Hypernatremia may occur with PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP)). Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia.
Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see PRECAUTIONS . Avoid PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations.
Hypermagnesemia Avoid solutions containing magnesium including PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with or predisposed to hypermagnesemia, including patients with severe renal impairment and those patients receiving magnesium therapy (e.g., treatment of eclampsia and myasthenia gravis). PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is not indicated for the treatment of hypomagnesemia. Acidosis PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is not for use for the treatment of lactic acidosis or severe metabolic acidosis in patients with severe liver and/or renal impairment.
Alkalosis Excess administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can result in metabolic alkalosis. Avoid PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with alkalosis or at risk for alkalosis. PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is not indicated for the treatment of hypochloremic hypokalemic alkalosis.
Avoid use in patients with hypochloremic hypokalemic alkalosis. Hypocalcemia PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP)… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions associated with the use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) were identified in clinical trials or postmarketing reports. Because postmarketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Hypersensitivity and Infusion Reactions : tachycardia, chest pain, chest discomfort, dyspnea, flushing, hyperemia, asthenia, pyrexia, hypotension, wheezing, urticaria, cold sweat, chills.
General Disorders and Administration Site Conditions : infusion site pain, burning sensation. Metabolism and nutrition disorders : hyperkalemia, hyponatremia. Nervous System Disorders : hyponatremic encephalopathy.
Overdose Excessive administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause: • fluid overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. • hypernatremia and hyperkalemia, especially in patients with severe renal impairment. • hypermagnesemia. See WARNINGS and ADVERSE REACTIONS • metabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations. When assessing an overdose, any additives in the solution must also be considered.
The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP), dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).
🔄 Drug Interactions ▾
Drug Interactions Other Products that Affect Fluid and/or Electrolyte Balance Administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) to patients treated concomitantly with drugs associated with sodium and fluid retention, may increase the risk of hypernatremia and volume overload. Avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.
Other Drugs that Increase the Risk of Hyponatremia Administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids.
If use cannot be avoided, monitor serum sodium concentrations. Lithium Renal clearance of lithium may be increased during administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). Monitor serum lithium concentrations during concomitant use.
Other Products that Increase the Risk of Hyperkalemia Because of its potassium content, avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. If use cannot be avoided, monitor serum potassium concentrations. Drugs with pH Dependent Renal Elimination Due to its alkalinizing effect (formation of bicarbonate), PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may interfere with the elimination of drugs with pH dependent renal elimination.
Renal clearance of acidic drugs may be increased. Renal clearance of alkaline drugs may be decreased.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving Baxter gluconate containing PLASMA-LYTE solutions. These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving Baxter gluconate containing PLASMA-LYTE solutions should be interpreted cautiously and confirmed by other diagnostic methods.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). It is also not known whether PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use The use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in pediatric patients is based on clinical practice.
🧓 Geriatric Use ▾
Geriatric Use Geriatric patients are at increased risk of developing electrolyte imbalances. PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Consider monitoring renal function in elderly patients.
🆘 Overdosage ▾
Overdose Excessive administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause: • fluid overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. • hypernatremia and hyperkalemia, especially in patients with severe renal impairment. • hypermagnesemia. See WARNINGS and ADVERSE REACTIONS • metabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations. When assessing an overdose, any additives in the solution must also be considered.
The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP), dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient. PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) produces a metabolic alkalinizing effect.
Acetate and gluconate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in VIAFLEX plastic containers is available as shown below: Code Size (mL) NDC 2B2544 1000 NDC 0338-0221-04 2B2543 500 NDC 0338-0221-03 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.
📋 Description ▾
DESCRIPTION PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C 6 H 11 NaO 7 ); 368 mg of Sodium Acetate Trihydrate, USP (C 2 H 3 NaO 2 •3H 2 O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl 2 •6H 2 O). It contains no antimicrobial agents.
The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0). PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories.
One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is 280 to 310 mOsmol/L.
The caloric content is 21 kcal/L. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly.
Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
⚠️ Precautions ▾
PRECAUTIONS Patients with Renal Impairment In patients with renal impairment, administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may result in sodium and/or potassium or magnesium retention (see WARNINGS ). PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention or magnesium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.
Drug Interactions Other Products that Affect Fluid and/or Electrolyte Balance Administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) to patients treated concomitantly with drugs associated with sodium and fluid retention, may increase the risk of hypernatremia and volume overload. Avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.
Other Drugs that Increase the Risk of Hyponatremia Administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids.
If use cannot be avoided, monitor serum sodium concentrations. Lithium Renal clearance of lithium may be increased during administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). Monitor serum lithium concentrations during concomitant use.
Other Products that Increase the Risk of Hyperkalemia Because of its potassium content, avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. If use cannot be avoided, monitor serum potassium concentrations. Drugs with pH Dependent Renal Elimination Due to its alkalinizing effect (formation of bicarbonate), PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may interfere with the elimination of drugs with pH dependent renal elimination.
Renal clearance of acidic drugs may be increased. Renal clearance of alkaline drugs may be decreased. Drug/Laboratory Test Interactions There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving Baxter gluconate containing PLASMA-LYTE solutions.
These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving Baxter gluconate containing PLASMA-LYTE solutions should be interpreted cautiously and confirmed by other diagnostic methods. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). It is also not known whether PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause fetal harm… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is administered to a nursing mother.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection Type 1 USP) 1000mL Container Label Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection Type 1 USP) 1000mL Container Label 2B2544 NDC 0338-0221-04 Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection Type 1 USP) 1000 mL Each 100 mL contains 526 mg Sodium Chloride USP 502 mg Sodium Gluconate USP 368 mg Sodium Acetate Trihydrate USP 37 mg Potassium Chloride USP 30 mg Magnesium Chloride USP pH adjusted with Sodium Hydroxide ph 7.4 (6.5 to 8.0) mEq/L Sodium 140 Potassium 5 Magnesium 3 Chloride 98 Acetate 27 Gluconate 23 Osmolarity 294 mOsmol/L (calc) Sterile Nonpyrogenic Single dose container Additives may be incompatible Consult with pharmacist if available When introducing additives use aseptic technique Mix thoroughly Do not store Dosage Intravenously as directed by a physician See directions Cautions Squeeze and inspect inner bag which maintains product sterility Discard if leaks are found Must not be used in series connections Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLEX container PL 146 plastic BAXTER PLASMA-LYTE VIAFLEX and PL 146 are trademarks of Baxter International Inc For product information 1-800-933-0303 Baxter Baxter Healthcare Corporation Deerfield IL 60015 USA Made in USA Container Label
Medicaid utilization & spend
Medicaid utilization by pack size
Reported adverse events (FAERS)
Top reported reactions
Age at onset
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Serious outcomes
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |