Multiple Electrolytes pH 7.4 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 — NDC 65219-0389-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Multiple Electrolytes pH 7.4 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 — NDC 65219-389-05 (Billing 65219-0389-05)

by Fresenius Kabi USA, LLC · 20 BAG in 1 CASE / 500 mL in 1 BAG

This is a package of Multiple Electrolytes pH 7.4 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 Fresenius Kabi USA, LLC, marketed since Jun 2021 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 65219-0389-05
🏷️ FDA NDC (as labeled) 65219-389-05 billing pads the product segment with a zero
This package
Contains500 mL in 1 bag Pack sizes2 compare ↓
Also priced by: Part D plans $0.0206/unit — full pricing hub ↓
Main listing for product 65219-389 · Also comes in: 1000 ml 65219-389-10
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65219-389-05
Product NDC 65219-389
11-digit billing NDC 65219038905
NCPDP billing unit ML — per mL (volume)
RxCUI 801109
UNII 451W47IQ8X, R6Q3791S76, 4550K0SC9B, 660YQ98I10, 02F3473H9O
Application # ANDA215371
SPL Set ID 84221110-b3f1-42f4-800c-ad1d3b330e9e
Established class (EPC) Calculi Dissolution Agent; Inhibition Large Intestine Fluid/Electrolyte Absorptio
Physiologic effect Increased Large Intestinal Motility
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-17
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79992001602000
GCN Seq No 001447
GCN 04290
HICL code 000618
Ingredient (HICL) Electrolyte-A Solution
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1W
Therapeutic class — specific (HIC3) Electrolyte Maintenance
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name MULTIPLE ELECTROLYTES T1 PH7.4
FDB brand name Multiple Electrolytes T1 Ph7.4
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001447
  • GCN: 04290
  • GPI-14 (Medi-Span): 79992001602000
  • HICL (First Databank): 000618
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 801109
Why two NDCs? The FDA registers this code as 65219-389-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65219-0389-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Electrolyte solutions class.

Drug family (ATC) Electrolyte solutions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name MULTIPLE ELECTROLYTES T1 PH7.4 Ingredient Electrolyte-A Solution
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Magnesium Chloride / Potassium Chloride / Sodium Acetate / Sodium Chloride / Sodium Gluconate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0206 $206.00 / 10000 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65219-0389-05 You're viewing this Main listing 20 BAG in 1 CASE / 500 mL in 1 BAG 2022-10-21 — Active
65219-0389-10 65219-389-10 10 BAG in 1 CASE / 1000 mL in 1 BAG 2022-10-21 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 20 bag in 1 case / 500 ml in 1 bag.
What NDC number is used to bill for this package of Multiple Electrolytes pH 7.4 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?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Plasma-Lyte A 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL 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/100mLthis 65219-0389-05 Fresenius 500 ml — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA215371 (ANDA)
Labeler code65219
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio554 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 25 words ▾

INDICATIONS AND USAGE Multiple Electrolytes Injection, Type 1, USP, pH 7.4 is indicated as a source of water and electrolytes or as an alkalinizing agent.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Important Administration Instructions Multiple Electrolytes Injection, Type 1, USP, pH 7.4 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. Multiple Electrolytes Injection, Type 1, USP, pH 7.4 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. Multiple Electrolytes Injection, Type 1, USP, pH 7.4 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 23 words ▾

CONTRAINDICATIONS Multiple Electrolytes Injection, Type 1, USP, pH 7.4 is contraindicated in patients with a known hypersensitivity to the product. See WARNINGS .

⚠️ Warnings ~2 min read ▾

WARNINGS Hypersensitivity Reactions Hypersensitivity and infusion reactions have been reported with 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 Multiple Electrolytes Injection, Type 1, USP can cause electrolyte disturbances such as overhydration, and congested states, including pulmonary congestion and edema. Avoid 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 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 Multiple Electrolytes Injection, Type 1, USP. Avoid 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 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 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 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). Multiple Electrolytes Injection, Type 1, USP is not indicated for the treatment of hypomagnesemia. Acidosis 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 Multiple Electrolytes Injection, Type 1, USP can result in metabolic alkalosis. Avoid Multiple Electrolytes Injection, Type 1, USP in patients with alkalosis or at risk for alkalosis. 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 Multiple Electrolytes Injection, Type 1, USP contains no calcium, and an increase in plasma pH due to its alkalinizing effect may lower the concentration of ionized (not protein-bound) calcium. Avoid Multiple Electrolytes Injection, Type 1, USP in patients with hypocalcemia.

Hyperkalemia Potassium-containing solutions, including Multiple Electrolytes Injection, Type 1, USP may increase the risk of hyperkalemia. Patient's at increased risk of developing hyperkalemia include those: With conditions predisposing to hyperkalemia and/or ass… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 123 words ▾

ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions associated with the use of 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.

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.

🔄 Drug Interactions ~1 min read ▾

Drug Interactions Other Products that Affect Fluid and/or Electrolyte Balance Administration of 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 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 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 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 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 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), 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 71 words ▾

Drug/Laboratory Test Interactions There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving gluconate containing Multiple Electrolytes Injection, Type 1, USP solutions. These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving gluconate containing Multiple Electrolytes Injection, Type 1, USP solutions should be interpreted cautiously and confirmed by other diagnostic methods.

🤰 Pregnancy 61 words ▾

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with Multiple Electrolytes Injection, Type 1, USP. It is also not known whether Multiple Electrolytes Injection, Type 1, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Multiple Electrolytes Injection, Type 1, USP should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 19 words ▾

Pediatric Use The use of Multiple Electrolytes Injection, Type 1, USP in pediatric patients is based on clinical practice.

🧓 Geriatric Use 91 words ▾

Geriatric Use Geriatric patients are at increased risk of developing electrolyte imbalances. 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 121 words ▾

OVERDOSAGE Excessive administration of Multiple Electrolytes Injection, Type 1, USP, pH 7.4 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 Multiple Electrolytes Injection, Type 1, USP, pH 7.4, 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 65 words ▾

CLINICAL PHARMACOLOGY Multiple Electrolytes Injection, Type 1, USP, pH 7.4 has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient. Multiple Electrolytes Injection, Type 1, USP, pH 7.4 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 116 words ▾

HOW SUPPLIED Multiple Electrolytes Injection, Type 1, USP, pH 7.4 in free flex ® plastic containers is available as shown below: Product Code Unit of Use Unit of Sale 389150 NDC 65219-389-00 One 500 mL free flex ® Bag NDC 65219-389-05 Package of 20 free flex ® Bags 389100 NDC 65219-389-02 One 1000 mL free flex ® Bag NDC 65219-389-10 Package of 10 free flex ® Bags Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.].

Brief exposure up to 40°C does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

📋 Description ~1 min read ▾

DESCRIPTION Multiple Electrolytes Injection, Type 1, USP, pH 7.4 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). Multiple Electrolytes Injection, Type 1, USP, pH 7.4 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 flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). 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. 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 ~3 min read ▾

PRECAUTIONS Patients with Renal Impairment In patients with renal impairment, administration of Multiple Electrolytes Injection, Type 1, USP may result in sodium and/or potassium or magnesium retention (see WARNINGS ). Avoid 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 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 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 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 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 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 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), 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 gluconate containing Multiple Electrolytes Injection, Type 1, USP solutions.

These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving gluconate containing Multiple Electrolytes Injection, Type 1, USP solutions should be interpreted cautiously and confirmed by other diagnostic methods. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 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 Multiple Electrolytes Injection, Type 1, USP. It is also not known whether Multiple Electrolytes Injection, Type 1, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Multiple Electrolytes Injection, Type 1, USP should be given to a pregnant woman only if clearly needed.

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… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 39 words ▾

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 Multiple Electrolytes Injection, Type 1, USP is administered to a nursing mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 27 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Multiple Electrolytes Injection, Type 1, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

📖 Instructions for Use ~2 min read ▾

INSTRUCTIONS FOR USE For Information on Risk of Air Embolism – see DOSAGE AND ADMINISTRATION . Check solution container composition, lot number, and expiry date. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use solution containers in series connections. Do not remove solution container from its overwrap until immediately before use. The intact port caps provide visual tamper evidence.

Do not use if a port cap is prematurely removed. Maintain strict aseptic technique during handling. TO OPEN Always inspect the solution container before and after removal from the overwrap.

Place the solution container on a clean, flat surface. Using the pre-cut corner tabs, peel open the overwrap and remove the solution container from the overwrap. Check the solution container for leaks by squeezing firmly.

If leaks are found, discard as sterility may be impaired. Do not use if the solution is cloudy or a precipitate is present. TO PREPARE FOR ADMINISTRATION Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from the solution container.

Use a non-vented infusion set or close the air-inlet on a vented set. Close the roller clamp of the infusion set. Hold the base of BLUE Infusion Port, twist and push the spike until the spike is fully inserted.

Refer to complete directions accompanying set. The BLUE infusion port contains a self‐sealing septum that helps prevent leakage after removing the spike. The infusion port is not intended to be spiked more than once.

Suspend solution container from hanger hole. If supplemental medication is desired, follow directions below. TO ADD MEDICATION BEFORE SOLUTION ADMINISTRATION Identify WHITE Injection Port with arrow pointing toward solution container.

Immediately before injecting additives, break off WHITE Injection Port Cap with the arrow pointing toward solution container. Hold base of WHITE Injection Port. Insert needle (18 to 23 gauge) through the center of WHITE Injection Port's septum and inject additives.

Mix solution container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. TO ADD MEDICATION DURING SOLUTION ADMINISTRATION Close the clamp on the set.

Identify WHITE Injection Port with arrow pointing toward solution container. Immediately before injecting additives, break off WHITE Injection Port cap with the arrow pointing toward solution container. Hold base of WHITE Injection Port.

Insert needle (18 to 23 gauge) through the center of WHITE Injection Port's septum and inject additives. Remove container from IV pole and/or turn to an upright position. Evacuate both ports by squeezing them while container is in the upright position.

Mix solution container contents thoroughly. Return container to in use position and continue administration. For Single Use Only.

Discard unused portion. Manufactured for: Lake Zurich, IL 60047 Made in Germany 451767 www.fresenius-kabi.com/us Issued: September 2022 Fresenius Kabi Logo

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE LABEL - PRINCIPAL DISPLAY – Multiple Electrolytes Injection, Type 1, USP pH 7.4 500 mL Bag Label 500 mL NDC 65219-389-00 Multiple Electrolytes Injection, Type 1, USP pH

7.4Rx only 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. Electrolytes per 1,000 mL: Sodium 140 mEq; Potassium 5 mEq; Magnesium 3 mEq; Chloride 98 mEq; Acetate 27 mEq; Gluconate 23 mEq 294 mOsmol/Liter (Calc.) pH 7.4 (6.5 to 8.0) PACKAGE LABEL - PRINCIPAL DISPLAY – Multiple Electrolytes Injection, Type 1, USP pH 7.4 500 mL Bag Label

PACKAGE LABEL – PRINCIPAL DISPLAY – Multiple Electrolytes Injection, Type 1, USP pH 7.4 500 mL Shipper Label NDC 65219-389-05 389150 Multiple Electrolytes Injection, Type 1, USP pH 7.4 500 mL x 20 STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] until ready to use. Avoid excessive heat. PACKAGE LABEL – PRINCIPAL DISPLAY – Multiple Electrolytes Injection, Type 1, USP pH 7.4 500 mL Shipper Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Multiple Electrolytes Injection, Type 1, USP pH 7.4 1000 mL Bag Label 1000 mL NDC 65219-389-02 Multiple Electrolytes Injection, Type 1, USP pH

7.4Rx only 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. Electrolytes per 1,000 mL: Sodium 140 mEq; Potassium 5 mEq; Magnesium 3 mEq; Chloride 98 mEq; Acetate 27 mEq; Gluconate 23 mEq 294 mOsmol/Liter (Calc.) pH 7.4 (6.5 to 8.0) PACKAGE LABEL - PRINCIPAL DISPLAY – Multiple Electrolytes Injection, Type 1, USP pH 7.4 1000 mL Bag Label

PACKAGE LABEL – PRINCIPAL DISPLAY – Multiple Electrolytes Injection, Type 1, USP pH 7.4 1000 mL Shipper Label NDC 65219-389-10 389100 Multiple Electrolytes Injection, Type 1, USP pH 7.4 1000 mL x 10 STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] until ready to use. Avoid excessive heat. PACKAGE LABEL – PRINCIPAL DISPLAY – Multiple Electrolytes Injection, Type 1, USP pH 7.4 1000 mL Shipper Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
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 ✓ Available
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1000 ml (65219-0389-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.