FDA.reportPublic FDA data

Potassium Chloride in Dextrose and Sodium Chloride

Manufacturer
Fresenius Kabi USA, LLC | HP Halden Pharma AS
Effective date
2024-05-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 21:03:11

Label at a glance#

ProductPotassium Chloride in Dextrose and Sodium Chloride
Active ingredientDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE
Label structure22 sections

Indications and uses

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

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 concentrati...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Free Flex LogoFree Flex Logo

Rx only

Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Flexible Plastic Container

DESCRIPTION

DESCRIPTION SECTION

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 (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula:

FigureFigure

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 H2O.

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.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

WARNINGS

WARNINGS SECTION

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.

PRECAUTIONS

PRECAUTIONS SECTION

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:

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Studies with solutions from flexible plastic containers have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

PREGNANCY SECTION

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:

NURSING MOTHERS SECTION

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

Pediatric Use:

PEDIATRIC USE SECTION

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:

GERIATRIC USE SECTION

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.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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.

OVERDOSAGE

OVERDOSAGE SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

DRUG INTERACTIONS SECTION

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.

HOW SUPPLIED

HOW SUPPLIED SECTION

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.

INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE SECTION

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

  1. 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.
  2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
  3. Do not use if the solution is cloudy or a precipitate is present.

To Add Medication

  1. Identify WHITE Additive Port with arrow pointing toward container.
  2. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container.
  3. Hold base of WHITE Additive Port horizontally.
  4. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives.
  5. Mix container contents thoroughly.

Preparation for Administration

  1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
  2. Use a non-vented infusion set or close the air-inlet on a vented set.
  3. Close the roller clamp of the infusion set.
  4. Hold the base of BLUE Infusion Port.
  5. 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:

Fresenius Kabi LogoFresenius Kabi Logo

Lake Zurich, Illinois 60047

Made in Norway

451750
www.fresenius-kabi.com/us

Issued: May 2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 1000 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 1000 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 – 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 1000 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 – 30 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 1000 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 – 40 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL Bag Label
PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

NDC 65219-150-75       245075

10
mEq

Potassium Chloride in 5% Dextrose and
0.45% Sodium Chloride Injection, USP

500 mL x 20

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 – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1863607potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % in 500 ML InjectionPSN7
630796potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionPSN7
1863605potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSN7
615099potassium chloride 30 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSN7
615100potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSN7
6307961000 ML glucose 50 MG/ML / potassium chloride 0.01 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCD7
18636051000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCD7
6150991000 ML glucose 50 MG/ML / potassium chloride 0.03 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCD7
6151001000 ML glucose 50 MG/ML / potassium chloride 0.04 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCD7
1863607500 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCD7
6307961000 ML Glucose 50 MG/ML / K+ Chloride 0.01 MEQ/ML / NaCl 4.5 MG/ML InjectionSY7
18636051000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSY7
6150991000 ML Glucose 50 MG/ML / K+ Chloride 0.03 MEQ/ML / NaCl 4.5 MG/ML InjectionSY7
6151001000 ML Glucose 50 MG/ML / K+ Chloride 0.04 MEQ/ML / NaCl 4.5 MG/ML InjectionSY7
6307961000 ML Glucose 50 MG/ML / Pot Chloride 0.01 MEQ/ML / NaCl 4.5 MG/ML InjectionSY7
18636051000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSY7
6150991000 ML Glucose 50 MG/ML / Pot Chloride 0.03 MEQ/ML / NaCl 4.5 MG/ML InjectionSY7
6151001000 ML Glucose 50 MG/ML / Pot Chloride 0.04 MEQ/ML / NaCl 4.5 MG/ML InjectionSY7
1863607500 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSY7
1863607500 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSY7
630796potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSY7
1863607potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 500 ML InjectionSY7
1863605potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSY7
615099potassium chloride 30 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSY7
615100potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-142-02Potassium Chloride in Dextrose and Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION10007
65219-142-10Potassium Chloride in Dextrose and Sodium Chloride10 in 1 CASEINJECTION, SOLUTION107
65219-144-04Potassium Chloride in Dextrose and Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION10007
65219-144-10Potassium Chloride in Dextrose and Sodium Chloride10 in 1 CASEINJECTION, SOLUTION107
65219-146-06Potassium Chloride in Dextrose and Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION10007
65219-146-10Potassium Chloride in Dextrose and Sodium Chloride10 in 1 CASEINJECTION, SOLUTION107
65219-148-08Potassium Chloride in Dextrose and Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION10007
65219-148-10Potassium Chloride in Dextrose and Sodium Chloride10 in 1 CASEINJECTION, SOLUTION107
65219-150-00Potassium Chloride in Dextrose and Sodium Chloride500 mL in 1 BAGINJECTION, SOLUTION5007
65219-150-75Potassium Chloride in Dextrose and Sodium Chloride20 in 1 CASEINJECTION, SOLUTION207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-142POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20240509_fe5b5182-c859-4c74-b2e0-467be5b2e329.zip
65219-144POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20240509_fe5b5182-c859-4c74-b2e0-467be5b2e329.zip
65219-146POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20240509_fe5b5182-c859-4c74-b2e0-467be5b2e329.zip
65219-148POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20240509_fe5b5182-c859-4c74-b2e0-467be5b2e329.zip
65219-150POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20240509_fe5b5182-c859-4c74-b2e0-467be5b2e329.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-142-02ML - Milliliter65219-142e487528c-a069-4ae4-9b1f-a50a1598191512023-06-06
65219-142-10ML - Milliliter65219-1426d55d6fb-a657-4322-80ef-eea45e12217112023-06-06
65219-144-04ML - Milliliter65219-144731eb7b5-57ca-40f9-944a-fdee3a260da612023-06-06
65219-144-10ML - Milliliter65219-14407c451a8-8945-43bd-805c-e5005741628212023-06-06
65219-146-06ML - Milliliter65219-14622dc99e3-30fc-4c3d-891c-8b6bf68cfc2612023-06-06
65219-146-10ML - Milliliter65219-146ba1f0e82-b758-4eef-9a08-315b463d0a2a12023-06-06
65219-148-08ML - Milliliter65219-148c18e5f9b-1e58-4171-a820-7b2a7dc38d9b12023-06-06
65219-148-10ML - Milliliter65219-1489223d540-8100-4a07-80bc-c4458deb6ded12023-06-06
65219-150-00ML - Milliliter65219-150b40622f4-413a-4571-9550-bc6d8dbd928212023-06-06
65219-150-75ML - Milliliter65219-1508255db02-85f5-46fe-8d2a-24b50eaad76d12023-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65219-14265219-142-02, 65219-142-10
65219-14465219-144-04, 65219-144-10
65219-14665219-146-06, 65219-146-10
65219-14865219-148-08, 65219-148-10
65219-15065219-150-00, 65219-150-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213523-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE5GM/100ML;74.5MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09
A213523-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09
A213523-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE5GM/100ML;224MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09
A213523-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE5GM/100ML;298MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09
A213523-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2022-10-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A213523-001AP
A213523-002AP
A213523-003AP
A213523-004AP
A213523-005AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213523-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;74.5MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0984e616aacf4f…
2026-09-14 22:38:342026-08A213523-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0984e616aacf4f…
2026-09-14 22:38:342026-08A213523-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;224MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0984e616aacf4f…
2026-09-14 22:38:342026-08A213523-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;298MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0984e616aacf4f…
2026-09-14 22:38:342026-08A213523-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2022-10-1184e616aacf4f…
2026-08-18 06:07:402026-07A213523-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;74.5MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213523-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213523-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;224MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213523-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;298MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213523-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2022-10-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213523-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;74.5MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213523-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213523-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;224MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213523-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;298MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213523-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2022-10-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213523-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;74.5MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213523-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213523-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;224MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213523-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;298MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213523-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2022-10-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213523-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;74.5MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213523-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213523-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;224MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213523-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;298MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213523-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2022-10-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213523-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;74.5MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213523-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213523-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;224MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213523-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;298MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213523-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2022-10-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213523-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;74.5MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213523-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213523-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;224MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213523-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;298MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213523-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2022-10-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213523-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;74.5MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213523-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213523-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;224MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213523-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;298MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2021-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213523-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;149MG/100ML;450MG/100MLINJECTABLE / INJECTIONAP2022-10-1103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213523-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A213523-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A213523-003AP184e616aacf4f…
2026-09-14 22:38:342026-08A213523-004AP184e616aacf4f…
2026-09-14 22:38:342026-08A213523-005AP184e616aacf4f…
2026-08-18 06:07:402026-07A213523-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A213523-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A213523-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A213523-004AP1caaa826d4ba7…
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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCfe5b5182-c859-4c74-b2e0-467be5b2e3292024-05-06Warnings, Adverse reactionsExact identifier
ndc (package): 65219-148-08
ndc (package): 65219-142-02
ndc (package): 65219-142-10
ndc (package): 65219-144-10
ndc (package): 65219-144-04
ndc (package): 65219-150-00
ndc (package): 65219-148-10
ndc (package): 65219-150-75
ndc (package): 65219-146-06
ndc (package): 65219-146-10
ndc (product): 65219-144
ndc (product): 65219-146
ndc (product): 65219-148
ndc (product): 65219-142
ndc (product): 65219-150
ndc11 (package): 65219014606
ndc11 (package): 65219015075
ndc11 (package): 65219015000
ndc11 (package): 65219014808
ndc11 (package): 65219014410
ndc11 (package): 65219014810
ndc11 (package): 65219014202
ndc11 (package): 65219014404
ndc11 (package): 65219014210
ndc11 (package): 65219014610
spl id: 93737cd2-f9e0-41e1-9263-2c4ff516395a
spl set id: fe5b5182-c859-4c74-b2e0-467be5b2e329

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.