Isolyte P in Dextrose Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic 5 g/100mL; .32 g/100mL; .13 g/100mL; .031 g/100mL; .026 g/100mL Injection, Solution — NDC 00264-7730-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Isolyte P in Dextrose Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic 5 g/100mL; .32 g/100mL; .13 g/100mL; .031 g/100mL; .026 g/100mL Injection, Solution — NDC 0264-7730-10 (Billing 00264-7730-10)

by B. Braun Medical Inc. · 24 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER

This is a package of Isolyte P in Dextrose Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic 5 g/100mL; .32 g/100mL; .13 g/100mL; .031 g/100mL; .026 g/100mL Injection, Solution from B. Braun Medical Inc., marketed since Jun 1993 and currently FDA-listed. It is this product's only package size.

NDC 00264-7730-10
🏷️ FDA NDC (as labeled) 0264-7730-10 billing pads the labeler segment with a zero
Rx only Brand 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) 0264-7730-10
Product NDC 0264-7730
11-digit billing NDC 00264773010
NCPDP billing unit ML — per mL (volume)
RxCUI 800808, 800812
UNII LX22YL083G, 4550K0SC9B, 660YQ98I10, 02F3473H9O, CI71S98N1Z
Application # NDA019873
SPL Set ID 4ea4397c-2fa4-4670-91e6-21ae498c88f7
Established class (EPC) Calculi Dissolution Agent; Inhibition Large Intestine Fluid/Electrolyte Absorptio
Physiologic effect Increased Large Intestinal Motility
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1993-06-10
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC

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

GPI-14 79993002832010
GPI class Isolyte-P in D5W
GCN Seq No 001966
GCN 62120
HICL code 014869
Ingredient (HICL) Electrolyte-P Solution/D5W
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 ISOLYTE P-DEXTROSE 5% SOLN
FDB brand name Isolyte P With Dextrose
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001966
  • GCN: 62120
  • GPI-14 (Medi-Span): 79993002832010
  • HICL (First Databank): 014869
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 800808
Why two NDCs? The FDA registers this code as 0264-7730-10 — a 4-4-2 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 labeler segment → 00264-7730-10. 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 Other irrigating solutions class.

Drug family (ATC) Other irrigating solutions, Tests for diabetes, Carbohydrates
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 ISOLYTE P-DEXTROSE 5% SOLN Ingredient Electrolyte-P Solution/D5W
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 $0.0106 $127.20 / 12000 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
00264-7730-10 You're viewing this Main listing 24 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER 1993-06-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Isolyte P in Dextrose 5 g/100mL; .32 g/100mL; .13 g/100mL; .031 g/100mL; .026 g/100mLthis 00264-7730-10 B. 500 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
1993
On the market since
Jun 1993
📍
2026
Currently FDA-listed
33 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 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?
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

LabelerB. Braun Medical Inc.
Application holderB BRAUN MEDICAL INC
FDA applicationNDA019873 (NDA)
Labeler code00264
First marketedJun 1993
Product typeHuman Prescription Drug
Portfolio94 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 26 words ▾

INDICATIONS AND USAGE This solution is indicated for use in adults as a source of electrolytes, calories and water for hydration, and as an alkalinizing agent.

⏱️ Dosage and Administration 147 words ▾

DOSAGE AND ADMINISTRATION This solution is for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques.

Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 14 words ▾

CONTRAINDICATIONS Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

⚠️ Warnings 216 words ▾

WARNINGS The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

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 is sodium retention with edema. Solutions containing 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.

Infuse solutions containing phosphate slowly to avoid phosphate intoxication. Infusing high concentrations of phosphate may cause hypocalcemia and tetany. Serum phosphorus and calcium levels should be monitored frequently.

Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate should be done with great care in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency.

🤒 Adverse Reactions ~2 min read ▾

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. Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance.

Use of the largest peripheral vein and a small bore needle is recommended. (See DOSAGE AND ADMINISTRATION .) Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.

Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. Abnormally high plasma levels of magnesium can result in flushing, sweating, hypotension, circulatory collapse, and depression of cardiac and central nervous system function. Respiratory depression is the most immediate threat to life.

Magnesium deficits can result in tachycardia, hypertension, hyperirritability and psychotic behavior. Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability.

The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted. 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.

🔄 Drug Interactions 59 words ▾

Drug Interactions Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Administration of barbiturates, narcotics, hypnotics, or systemic anesthetics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect. Parenteral magnesium should be administered with extreme caution to patients receiving digitalis preparations.

🤰 Pregnancy 58 words ▾

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with Isolyte® P in 5% Dextrose. It is also not known whether Isolyte® P in 5% Dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isolyte® P in 5% Dextrose should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 101 words ▾

Geriatric Use In general, 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. This drug 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. 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.

See WARNINGS .

🆘 Overdosage 140 words ▾

OVERDOSAGE In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition, and institute appropriate corrective treatment. In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels. Treatment of hyperkalemia includes the following: Dextrose Injection USP, 10% or 25% containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL per hour.

Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema. Hemodialysis and peritoneal dialysis. The use of potassium-containing foods or medications must be eliminated.

However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity. Over-aggressive phosphate replacement may precipitate hypocalcemic tetany. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Isolyte® P in 5% Dextrose provides electrolytes and calories, and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids.

Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Magnesium, a principal cation of soft tissue, is primarily involved in enzyme activity associated with the metabolism of carbohydrates and protein. Magnesium is also involved in neuromuscular irritability. Phosphate is a major intracellular anion which participates in providing energy for metabolism of substrates and contributes to significant metabolic and enzymatic reactions in almost all organs and tissues.

It exerts a modifying influence on calcium levels, a buffering effect on acid-base equilibrium and has a primary role in the renal excretion of hydrogen ions. Acetate is an organic ion which is a hydrogen ion acceptor and contributes bicarbonate during its metabolism to carbon dioxide and water, and in sufficient quantities may serve as an alkalinizing agent. Dextrose provides a source of calories.

Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

📦 How Supplied / Storage and Handling 68 words ▾

HOW SUPPLIED Isolyte ® P (Multi-Electrolyte Injection) in 5% Dextrose is supplied sterile and nonpyrogenic in EXCEL® containers. The 500 mL containers are packaged 24 per case. NDC REF Size Isolyte® P in 5% Dextrose 0264-7730-10 L7301 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25 ° C).

📦 Storage and Handling 29 words ▾

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25 ° C).

📋 Description ~2 min read ▾

DESCRIPTION Each 100 mL of Isolyte® P (Multi-Electrolyte Injection) in 5% Dextrose contains: Hydrous Dextrose USP 5 g; Sodium Acetate Trihydrate USP 0.32 g Potassium Chloride USP 0.13 g; Magnesium Chloride Hexahydrate USP 0.031 g Dibasic Potassium Phosphate USP 0.026 g; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.0 (4.0–6.0) Calories per liter: 170 Calculated Osmolarity: 340 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 23; Chloride 29 Acetate (CH 3 COO - ) 23; Potassium 20; Magnesium 3; 1.5 mmole P/liter Phosphate (HPO ) 3 Isolyte® P in 5% Dextrose is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents or added buffers.

This product is intended for intravenous administration. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Acetate Trihydrate USP CH 3 COONa•3H 2 O 136.08 Potassium Chloride USP KCl

74.55Magnesium Chloride Hexahydrate USP MgCl 2 •6H 2 O 203.30 Dibasic Potassium Phosphate USP K 2 HPO 4 174.18 Hydrous Dextrose USP 198.17 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers.

The solution contact layer is a rubberized copolymer of ethylene and propylene. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. The container-solution unit is a closed system and is not dependent upon entry of external air during administration.

The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses.

It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication site.

Refer to the Directions for Use of the container. =4 special character Chemical Structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, impending or frank cardiac decompensation. Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. Additional essential electrolytes, minerals, and vitamins should be supplied as needed.

Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels.

Solutions containing potassium or magnesium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease. Solutions containing acetate should be used with caution. Excess administration may result in metabolic alkalosis.

Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. Do not use plastic containers in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

This solution is intended for intravenous administration using sterile equipment. Use only if solution is clear and container and seals are intact. Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added. Drug Interactions Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Administration of barbiturates, narcotics, hypnotics, or systemic anesthetics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect.

Parenteral magnesium should be administered with extreme caution to patients receiving digitalis preparations. Carcinogenesis, mutagenesis, impairment of fertility Long term animal studies with Isolyte ® P (Multi-Electrolyte Injection) in 5% Dextrose have not been performed to evaluate the carcinogenic potential, mutagenic potential, or effects on fertility. Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with Isolyte® P in 5% Dextrose.

It is also not known whether Isolyte® P in 5% Dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isolyte® P in 5% Dextrose should be given to a pregnant woman only if clearly needed. Labor and Delivery As reported in the literature, Dextrose and electrolyte solutions have been administered during labor and delivery.

Caution should be exercised, and the… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 18 words ▾

Nursing Mothers Caution should be exercised when Isolyte® P in 5% Dextrose is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 33 words ▾

Carcinogenesis, mutagenesis, impairment of fertility Long term animal studies with Isolyte ® P (Multi-Electrolyte Injection) in 5% Dextrose have not been performed to evaluate the carcinogenic potential, mutagenic potential, or effects on fertility.

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 500 mL Container Label Isolyte ® P in 5% Dextrose (Multi-Electrolyte Injection) REF L7301 NDC 0264-7730-10 HK 22411 500 mL EXCEL ® CONTAINER Electrolytes (mEq/liter): Na + 23 K + 20 Mg ++ 3 Cl – 29 Acetate 23 Phosphate (HPO ) 3 (1.5 mmole P/L) Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Acetate•3H 2 O USP 0.32 g; Potassium Chloride USP 0.13 g; Magnesium Chloride•6H 2 O USP 0.031 g; Dibasic Potassium Phosphate USP 0.026 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.0 (4.0-6.0) Calc Osmolarity: 340 mOsmol/liter Sterile, nonpyrogenic.

Single dose container. Do not use in series connection. For intravenous use only.Use only if solution is clear and container and seals are intact.

WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques.

Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C).

Avoid excessive heat. Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL and Isolyte are registered trademarks of B. Braun Medical Inc.

B. Braun Medical Inc. Bethlehem, PA 18018 3524 USA 1-800-227-2862 Y94-003-244 LD-145-4 EXP LOT Special Character Recycle 7 500 mL container label L7301

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Isolyte P in Dextrose (this brand).

Top reported reactions

Alanine Aminotransferase Increased2
Aspartate Aminotransferase Increased2
Blood Bilirubin Increased2
Drug Abuse2
Gamma-glutamyltransferase Increased2
Neuroleptic Malignant Syndrome2
Anaemia1

Reporter sex

0 reports
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 3 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 — 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) — 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 B. Braun Medical Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
B. Braun Medical Inc. 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.