Home › NDC Lookup › Ingredients › Dextrose Monohydrate, Sodium Chloride, A... › 65219-0148-10
Potassium Chloride in Dextrose and Sodium 50 g/1000mL; 4.5 g/1000mL; 2.98 g/1000mL Injection, Solution — NDC 65219-0148-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Potassium Chloride in Dextrose and Sodium 50 g/1000mL; 4.5 g/1000mL; 2.98 g/1000mL Injection, Solution — NDC 65219-148-10 (Billing 65219-0148-10)

by Fresenius Kabi USA, LLC · 10 BAG in 1 CASE / 1000 mL in 1 BAG

This is a package of Potassium Chloride in Dextrose and Sodium 50 g/1000mL; 4.5 g/1000mL; 2.98 g/1000mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Aug 2022 and currently FDA-listed. It is this product's only package size.

NDC 65219-0148-10
🏷️ FDA NDC (as labeled) 65219-148-10 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 65219-148-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65219 labeler · 148 product · 10 package
Package marketed since
Aug 26, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6521914810 4
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65219-148-10
Product NDC 65219-148
11-digit billing NDC 65219014810
NCPDP billing unit ML — per mL (volume)
RxCUI 615099, 615100, 630796, 1863605, 1863607
UNII 451W47IQ8X, LX22YL083G, 660YQ98I10
Application # ANDA213523
SPL Set ID fe5b5182-c859-4c74-b2e0-467be5b2e329
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-26
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 79993003102050
GCN Seq No 002005
GCN 62661
HICL code 014778
Ingredient (HICL) Potassium Chloride/D5-0.45Nacl
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1D
Therapeutic class — specific (HIC3) Potassium Replacement
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name KCL 40 MEQ/L-D5W-0.45% NACL
FDB brand name Kcl-D5W-0.45% Nacl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002005
  • GCN: 62661
  • GPI-14 (Medi-Span): 79993003102050
  • HICL (First Databank): 014778
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 615099
Why two NDCs? The FDA registers this code as 65219-148-10 — 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 → 65219-0148-10. 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 KCL 40 MEQ/L-D5W-0.45% NACL Ingredient Potassium Chloride/D5-0.45Nacl

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $0.0091 $91.00 / 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
65219-0148-10 You're viewing this Main listing 10 BAG in 1 CASE / 1000 mL in 1 BAG 2022-08-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Chloride in Dextrose and Sodium Chloride 5 g/100mL; .45 g/100mL; .3 g/100mL 00264-7638-00 B. 1000 ml — — FDA listed —
Potassium Chloride in Dextrose and Sodium Chloride 300 mg/100mL; 5 g/100mL; 450 mg/100mL 00338-0675-04 Baxter 1000 ml — — FDA listed —
Potassium Chloride in Dextrose and Sodium Chloride 50 g/1000mL; 4.5 g/1000mL; 2.98 g/1000mL 00990-7904-09 ICU 12 pouches — AP FDA listed —
Potassium Chloride in Dextrose and Sodium Chloride 50 g/1000mL; 4.5 g/1000mL; 2.98 g/1000mLthis 65219-0148-10 Fresenius 1000 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

🏛️
2022
On the market since
Aug 2022
📍
2026
Currently FDA-listed
4 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 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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA213523 (ANDA)
Labeler code65219
First marketedAug 2022
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 65219

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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

INDICATIONS AND USAGE These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.

⏱️ Dosage and Administration 183 words ▾

DOSAGE AND ADMINISTRATION These solutions should be administered only by intravenous infusion and as directed by the physician. The dose and rate of injection are dependent upon the age, weight and clinical condition of the patient. If the serum potassium level is greater than 2.5 mEq/liter, potassium should be given at a rate not to exceed 10 mEq/hour in a concentration less than 30 mEq/liter.

Somewhat faster rates and greater concentrations (usually up to 40 mEq/liter) of potassium may be indicated in patients with more severe potassium deficiency. The total 24- hour dose should not generally exceed 200 mEq of potassium. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered.

⚠️ Warnings 177 words ▾

WARNINGS Solutions which contain potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with severe renal insufficiency or adrenal insufficiency, administration of potassium chloride may cause potassium intoxication.

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. The intravenous administration of these solutions can cause fluid and/or solute overloading 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 of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Reactions which may occur because of the solutions or technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. Nausea, vomiting, abdominal pain and diarrhea have been reported with potassium therapy.

The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest. Potassium-containing solutions are intrinsically irritating to tissues. Therefore, extreme care should be taken to avoid perivascular infiltration.

Local tissue necrosis and subsequent sloughing may result if extravasation occurs. Chemical phlebitis and venospasm have also been reported. Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once.

Local infiltration of the affected area with procaine hydrochloride, 1%, to which hyaluronidase may be added, will often reduce venospasm and dilute the potassium remaining in the tissues locally. Local application of heat may also be helpful. 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 46 words ▾

Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

🤰 Pregnancy 59 words ▾

Pregnancy Animal reproduction studies have not been conducted with dextrose, potassium chloride or sodium chloride. It is also not known whether dextrose, potassium chloride or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose, potassium chloride or sodium chloride should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 86 words ▾

Pediatric Use: The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

🧓 Geriatric Use 115 words ▾

Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. 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. Sodium and potassium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions 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.

🆘 Overdosage 26 words ▾

OVERDOSAGE In the event of potassium overdosage, discontinue the infusion immediately and institute intensive corrective therapy to reduce serum potassium levels. See WARNINGS and PRECAUTIONS .

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY When administered intravenously, these solutions provide a source of water and potassium chloride with carbohydrate (dextrose) and sodium chloride. See HOW SUPPLIED section for specific concentrations of these various solutions. Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories.

Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein- sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water. Intravenous solutions containing potassium chloride are particularly intended to provide needed potassium cation (K + ).

Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). Potassium plays an important role in electrolyte balance.

Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. A deficiency of either potassium or chloride will lead to a deficit of the other.

Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl − ) ions. Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl − ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells.

The distribution and excretion of sodium (Na + ) and chloride (Cl − ) are largely under the control of the kidney which maintains a balance between intake and output. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

📦 How Supplied / Storage and Handling 180 words ▾

HOW SUPPLIED Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP is supplied in single-dose free flex ® plastic containers as follows: Product Code Unit of Use Strength Unit of Sale 245075 NDC 65219-150-00 One 500 mL free flex ® bag 10 mEq Potassium Chloride NDC 65219-150-75 Package of 20 free flex ® bags 224210 NDC 65219-142-02 One 1000 mL free flex ® bag 10 mEq Potassium Chloride NDC 65219-142-10 Package of 10 free flex ® bags 244410 NDC 65219-144-04 One 1000 mL free flex ® bag 20 mEq Potassium Chloride NDC 65219-144-10 Package of 10 free flex ® bags 244610 NDC 65219-146-06 One 1000 mL free flex ® bag 30 mEq Potassium Chloride NDC 65219-146-10 Package of 10 free flex ® bags 244810 NDC 65219-148-08 One 1000 mL free flex ® bag 40 mEq Potassium Chloride NDC 65219-148-10 Package of 10 free flex ® bags Avoid excessive heat.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

📋 Description ~2 min read ▾

DESCRIPTION Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See table below for summary of content and characteristics of these solutions.

Table 1 COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na + ) Potassium (K + ) Chloride (Cl - ) Approximate Kcal/L 10 mEq 500 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 10 mEq 1000 50 4.5 0.745 426 4.2 (3.5 to 6.5) 77 10 87 170 20 mEq 1000 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 30 mEq 1000 50 4.5 2.24 467 4.2 (3.5 to 6.5) 77 30 107 170 40 mEq 1000 50 4.5 2.98 487 4.2 (3.5 to 6.5) 77 40 117 170 May contain HCl for pH adjustment.

The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers.

Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag) . Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

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. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the 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. Figure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS 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. Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.

Potassium replacement therapy should be guided primarily by serial electrocardiograms. Plasma potassium levels are not necessarily indicative of tissue potassium levels. High plasma concentrations of potassium may cause death through cardiac depression, arrhythmias or arrest.

Potassium-containing solutions should be used with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease. Care should be exercised to insure that the needle (or catheter) is well within the lumen of the vein and that extravasation does not occur. Do not administer unless solution is clear and container is undamaged.

Discard unused portion. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with solutions from flexible plastic containers have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregnancy Animal reproduction studies have not been conducted with dextrose, potassium chloride or sodium chloride.

It is also not known whether dextrose, potassium chloride or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose, potassium chloride or sodium chloride should be given to a pregnant woman only if clearly needed. Nursing Mothers: Caution should be exercised when solutions from flexible plastic containers are administered to a nursing mother.

Pediatric Use: The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage. Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. 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.

Sodium and potassium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions 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.

🍼 Nursing Mothers 18 words ▾

Nursing Mothers: Caution should be exercised when solutions from flexible plastic containers are administered to a nursing mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 26 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with solutions from flexible plastic containers have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

📖 Instructions for Use ~1 min read ▾

INSTRUCTIONS FOR USE Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique.

Flexible Plastic Container ( free flex ® bag) To Open Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. Check the solution container for leaks by squeezing firmly.

If leaks are found, or if the seal is not intact, discard the solution. Do not use if the solution is cloudy or a precipitate is present. To Add Medication Identify WHITE Additive Port with arrow pointing toward container.

Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. Hold base of WHITE Additive Port horizontally. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives.

Mix container contents thoroughly. Preparation for Administration Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from 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. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted.

NOTE: See full directions accompanying administration set. WARNING: Do not use flexible container in series connections. Manufactured for: Lake Zurich, Illinois 60047 Made in Norway 451750 www.fresenius-kabi.com/us Issued: May 2022 Fresenius Kabi Logo

📄 Package Label / Principal Display Panel ~3 min read ▾

PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 10 mEq POTASSIUM 1000 mL NDC 65219- 142 -02 free flex ® 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label

PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-142-10 224210 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat.

PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label

PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 20 mEq POTASSIUM 1000 mL NDC 65219- 144 -04 free flex ® 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label

PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-144-10 244410 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat.

PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label

PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 30 mEq POTASSIUM 1000 mL NDC 65219- 146 -06 free flex ® 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label

PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-146-10 244610 30 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat.

PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label

PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 40 mEq POTASSIUM 1000 mL NDC 65219- 148 -08 free flex ® 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label

PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-148-10 244810 40 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat.

PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label

PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL Bag Label 10 mEq POTASSIUM 500 mL NDC 65219- 150 -00 free flex ® 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHL… [Excerpted — this section continues on DailyMed.]

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.
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.
← 65219-0146-10 · Fresenius 65219-0150-75 · Fresenius →
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.