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Potassium Chloride 150 mg/100mL; 5 g/100mL Injection, Solution — NDC 63323-0669-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Potassium Chloride 150 mg/100mL; 5 g/100mL Injection, Solution — NDC 63323-669-10 (Billing 63323-0669-10)

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

This is a package of Potassium Chloride 150 mg/100mL; 5 g/100mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Apr 2021 and currently FDA-listed. It is this product's only package size.

NDC 63323-0669-10
🏷️ FDA NDC (as labeled) 63323-669-10 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 Sep 24, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-669-10
Product NDC 63323-669
11-digit billing NDC 63323066910
NCPDP billing unit ML — per mL (volume)
RxCUI 309783, 2566844
UNII LX22YL083G, 660YQ98I10
Application # ANDA212346
SPL Set ID 55d9ae37-4553-47e7-a2e3-86b48b5227cd
Established class (EPC) Osmotic Laxative; Potassium Salt
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
Chemical class Potassium Compounds
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-23
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 79993002102020
GCN Seq No 001949
GCN 62111
HICL code 014775
Ingredient (HICL) Potassium Chloride In 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 C1D
Therapeutic class — specific (HIC3) Potassium Replacement
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name KCL 20 MEQ/L IN D5W SOLUTION
FDB brand name Potassium Chloride-Dextrose 5%
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001949
  • GCN: 62111
  • GPI-14 (Medi-Span): 79993002102020
  • HICL (First Databank): 014775
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 309783
Why two NDCs? The FDA registers this code as 63323-669-10 — 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 → 63323-0669-10. 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 20 MEQ/L IN D5W SOLUTION Ingredient Potassium Chloride In D5W
📗 Our plain-language guide HelloPharmacist
  • It treats and prevents low potassium. Doctors often use it when you take diuretics or lose fluids through diarrhea or vomiting and food alone isn't enough. The injection is used in...
  • Take tablets and capsules with meals, not on an empty stomach, to protect your stomach. Powders and liquids need to be diluted first. Follow your prescriber's directions and keep y...
  • The most common issue is stomach upset. Taking it with food helps. Call your doctor if you have severe vomiting, belly pain, swelling or bleeding, since that can mean an ulcer or b...
  • Check with me first. Blood pressure medicines such as ACE inhibitors and ARBs, spironolactone, and NSAIDs can raise potassium. Triamterene and amiloride should be avoided with it.
📖 Read our full Potassium Chloride guide →

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 $0.0048 $48.00 / 10000 ml
Medicare Part B allowsASP · J3480 $0.136 / J3480 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)63323-669-10
11-digit billing NDC63323-0669-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3480
DescriptorInjection, potassium chloride, per 2 meq
Billing units / pkg100 units
How the units are derivedThis package is 1000; the HCPCS unit is 2 MEQ, so one package = 100 billing units.
Medicare Part B spend (2026 (Q1))$11,682 · 8,536 claims · $1.37 per claim (all NDCs under J3480)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63323-0669-10 You're viewing this Main listing 10 BAG in 1 CASE / 1000 mL in 1 BAG 2021-04-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Chloride In Dextrose 5 g/100mL; .15 g/100mL 00264-7625-00 B. 1000 ml — — FDA listed —
Potassium Chloride in Dextrose 150 mg/100mL; 5 g/100mL 00338-0683-04 Baxter 1000 ml — AP FDA listed —
Potassium Chloride in Dextrose 5 g/100mL; .149 g/100mL 00990-7905-09 ICU 12 pouches — — FDA listed —
Potassium Chloride 150 mg/100mL; 5 g/100mLthis 63323-0669-10 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

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

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

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

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 applicationANDA212346 (ANDA)
Labeler code63323
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio554 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND USAGE Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories. Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Only for intravenous infusion. ( 2.1 , 5.2 ) See full prescribing information for information on preparation, administration, dosing considerations and instructions for use. ( 2.1 , 2.2 , 2.3 )

2.1Important Administration Instructions Potassium Chloride in 5% Dextrose Injection is only for intravenous infusion [see Warnings and Precautions ( 5.2 )] . For patients receiving Potassium Chloride in 5% Dextrose Injection at greater than maintenance rates, frequent monitoring of serum potassium concentrations and serial electrocardiograms (ECGs) are recommended. The osmolarity of 10 mEq Potassium Chloride in 5% Dextrose Injection is 272 mOsmol/L (calc).

The osmolarity of 20 mEq Potassium Chloride in 5% Dextrose is 293 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain. Do not administer Potassium Chloride in 5% Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudo agglutination or hemolysis.

To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry. Prior to infusion, visually inspect the solution for particulate matter. The solution should be clear and there should be no precipitates.

Do not administer unless solution is clear and container is undamaged. Use of a final filter is recommended during administration of parenteral solutions, where possible.

2.2Recommended Dosage The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient. The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient's tolerance to dextrose.

Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] .

2.3Instructions 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. Check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates.

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.

Suspend solution container from hanger hole. To Add Medication Additives may be incompatible. Complete information is not available.

Do not use additives known or determined to be incompatible. Before adding a substance or medication, verify that it is soluble and/or stable in this drug product and that the pH range of this drug product is appropriate. Consult with pharmacist,… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 78 words ▾

3 DOSAGE FORMS AND STRENGTHS Potassium Chloride in 5% Dextrose Injection, USP is a clear solution in a 1000 mL single-dose, flexible container ( free flex ® ): 10 mEq Potassium Chloride and 5% Dextrose 20 mEq Potassium Chloride and 5% Dextrose Injection: 10 mEq Potassium Chloride in 5% Dextrose Injection, USP in a 1000 mL single-dose flexible container. 20 mEq Potassium Chloride in 5% Dextrose Injection, USP in a 1000 mL single-dose flexible container. ( 3 )

⛔ Contraindications 74 words ▾

4 CONTRAINDICATIONS Potassium Chloride in 5% Dextrose Injection is contraindicated in patients with: known hypersensitivity to potassium chloride and/or dextrose [see Warnings and Precautions 5.1 )] clinically significant hyperkalemia [see Warnings and Precautions ( 5.2 )] clinically significant hyperglycemia [see Warnings and Precautions ( 5.3 )] Known hypersensitivity to potassium chloride or dextrose ( 4 , 5.1 ) Clinically significant hyperkalemia ( 4 , 5.2 ) Clinically significant hyperglycemia ( 4 , 5.3 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.1 ) Hyperkalemia : May result in cardiac arrhythmias. Avoid use in patients with, or at risk for, hyperkalemia.

If use cannot be avoided, use a product with a low amount of potassium chloride, infuse slowly and monitor serum potassium concentrations and ECGs. ( 5.2 ) Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.3 , 8.4 ) Hyponatremia : Avoid in patients with or at risk for hyponatremia.

If use cannot be avoided, monitor serum sodium concentrations. ( 5.4 , 8.4 ) Hypokalemia: Avoid in patients with or at risk for hypokalemia. If use cannot be avoided, monitor serum potassium levels.

( 5.5 ) Fluid Overload : Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance and electrolyte, concentrations and acid-base balance, as needed and especially during prolonged use. ( 5.6 ) Refeeding Syndrome : Monitor severely undernourished patients and slowly increase nutrient intake.

( 5.7 )

5.1Hypersensitivity Reactions Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with Potassium Chloride in 5% Dextrose Injection [see Adverse Reactions ( 6 )] . Stop the infusion immediately if signs or symptoms of a hypersensitivity or infusion reaction develops [see Contraindications ( 4 )] . Appropriate therapeutic countermeasures must be instituted as clinically indicated.

5.2Hyperkalemia Potassium-containing solutions, including Potassium Chloride in 5% Dextrose Injection may increase the risk of hyperkalemia. Hyperkalemia can be asymptomatic and manifest only by increased serum potassium concentrations and/or characteristic electrocardiographic (ECG) changes. Cardiac arrhythmias, some fatal, can develop at any time during hyperkalemia.

To avoid life threatening hyperkalemia, do not administer Potassium Chloride in 5% Dextrose Injection as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access, without quantitative infusion device [see Dosage and Administration ( 2.1 )] . Patients at increased risk of developing hyperkalemia and cardiac arrhythmias include those: with severe renal impairment, acute dehydration, extensive tissue injury or burns, and certain cardiac disorders such as congestive heart failure or AV block (especially if they receive digoxin). with hyperosmolality, acidosis, or undergoing correction of alkalosis (conditions associated with a shift of potassium from intracellular to extracellular space). treated concurrently or recently with agents or products that can cause or increase the risk of hyperkalemia [see Drug Interactions ( 7.1 )] .

Avoid use of Potassium Chloride in 5% Dextrose Injection in patients with, or at risk for, hyperkalemia. If use cannot be avoided, use a product with a low amount of potassium chloride, infuse slowly and monitor serum potassium concentrations and ECGs.

5.3Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient's utilization rate may lead to hyperglycemia, coma, and death. Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses [see Warnings and Precautions ( 5.6 )] .

Patients with underlying central nervous system disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose concentrations and treat hyperglycemia to maintain concentrations within normal limits while administering Potassium Chloride in 5% Dextrose Injection. Insulin may be administered or adjusted to maintain optimal blood glucose concentrations.

5.4Hyponatremia P… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 192 words ▾

6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in 5% Dextrose Injection were identified in post marketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions : including anaphylaxis and chills [see Warnings and Precautions ( 5.1 )] .

Hyperkalemia, including cardiac arrest, as a manifestation [see Warnings and Precautions ( 5.2 )] Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] Hypokalemia [see Warnings and Precautions ( 5.5 )] Hypervolemia [see Warnings and Precautions ( 5.6 )] Injection site reactions : infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, infusion site rash, infusion site pain, infusion site vesicles, infusion site pruritus, pyrexia and chills Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Other Products that Cause Hyperkalemia : Avoid use in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. ( 7.1 ) Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance : Monitor blood glucose concentrations, fluid balance serum electrolyte concentrations and acid-base balance. ( 7.2 )

7.1Other Products that Cause Hyperkalemia Administration of Potassium Chloride in 5% Dextrose Injection in patients treated concurrently or recently with other products that can cause hyperkalemia or increase the risk of hyperkalemia (e.g., potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions ( 5.2 )] . Avoid use of Potassium Chloride in 5% Dextrose Injection in patients receiving such products.

If use cannot be avoided, monitor serum potassium concentrations.

7.2Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Potassium Chloride in 5% Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions ( 5.3 , 5.4 , 5.5 , 5.6 )] . Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Potassium Chloride in 5% Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Appropriate administration of Potassium Chloride in 5% Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Potassium Chloride in 5% Dextrose Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary Potassium is present in human breast milk. There are no data on the effects of Potassium Chloride in 5% Dextrose Injection on a breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Potassium Chloride in 5% Dextrose Injection and any potential adverse effects on the breastfed infant from Potassium Chloride in 5% Dextrose Injection or from the underlying maternal condition.

8.4Pediatric Use The safety profile of Potassium Chloride in 5% Dextrose Injection in pediatric patients is similar to adults. Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes.

In very low birth weight infants, excessive or rapid administration of Potassium Chloride in 5% Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

8.5Geriatric Use Potassium Chloride in 5% Dextrose Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this product may be greater in patients with impaired renal function [see Warnings and Precautions ( 5.2 , 5.3 )] . Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] . Dose selection for an elderly patient should be cautious, 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.

8.6Renal Impairment Administration of Potassium Chloride in 5% Dextrose Injection in patients with renal impairment may result in hyperkalemia, hyponatremia, and/or fluid overload. Monitor patients with renal impairment for development of these adverse reactions [see Warnings and Precautions ( 5.2 , 5.4 , 5.6 )] .

🤰 Pregnancy 98 words ▾

8.1Pregnancy Risk Summary Appropriate administration of Potassium Chloride in 5% Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Potassium Chloride in 5% Dextrose Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 128 words ▾

8.4Pediatric Use The safety profile of Potassium Chloride in 5% Dextrose Injection in pediatric patients is similar to adults. Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes.

In very low birth weight infants, excessive or rapid administration of Potassium Chloride in 5% Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

🧓 Geriatric Use 107 words ▾

8.5Geriatric Use Potassium Chloride in 5% Dextrose Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this product may be greater in patients with impaired renal function [see Warnings and Precautions ( 5.2 , 5.3 )] . Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] . Dose selection for an elderly patient should be cautious, 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.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Excess administration of Potassium Chloride in 5% Dextrose Injection can cause: Hyperkalemia Manifestations of hyperkalemia may include: disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation, and ECG changes (peaking of T waves, loss of P waves, and QRS widening) hypotension, muscle weakness up to and including muscular and respiratory paralysis, paresthesia of extremities, gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain) The presence of any ECG findings that are suspected to be caused by hyperkalemia should be considered a medical emergency.

If hyperkalemia is present or suspected, discontinue the infusion immediately and institute close ECG, laboratory and other monitoring and, as necessary, corrective therapy to reduce serum potassium concentrations [see Warnings and Precautions ( 5.2 )] . Other Electrolyte and Fluid Disorders Hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance, and corresponding complications, which can be fatal [see Warnings and Precautions ( 5.3 , 5.6 )] . Hyponatremia, manifestations may include seizures, coma, cerebral edema and death) [see Warnings and Precautions ( 5.4 )] .

Fluid overload (which can lead to central and/or peripheral edema) [see Warnings and Precautions ( 5.6 )] . Hypernatremia, especially in patients with severe renal impairment. Interventions include discontinuation of the infusion, dose reduction, monitoring of fluid balance, electrolyte concentrations and acid-base balance and institution of appropriate corrective measures such as administration of exogenous insulin.

🧬 Clinical Pharmacology 35 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Potassium Chloride in 5% Dextrose Injection is a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

🧬 Mechanism of Action 32 words ▾

12.1Mechanism of Action Potassium Chloride in 5% Dextrose Injection is a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

📦 How Supplied / Storage and Handling 118 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride in 5% Dextrose Injection, USP is a clear solution in 1000 mL single-dose, flexible containers available as follows: Product code Unit of Use Strength Unit of Sale 667110 NDC 63323-667-01 One 1000 mL free flex ® Bag 10 mEq Potassium NDC 63323-667-10 Package of 10 free flex ® Bags 669110 NDC 63323-669-01 One 1000 mL free flex ® Bag 20 mEq Potassium NDC 63323-669-10 Package of 10 free flex ® Bags Avoid excessive heat. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; brief exposure up to 40°C does not adversely affect the product.

The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

📋 Description 216 words ▾

11 DESCRIPTION Potassium Chloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single-dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 .

Table 1 * Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. ** Size (mL) Composition (g/L) Ionic Concentration (mEq/L) Caloric Content (kcal/L) Potassium Chloride in 5% Dextrose Injection, USP **Dextrose Hydrous, USP Potassium Chloride, USP (KCl) *Osmolarity (mOsmol/L) (calc.) pH Potassium Chloride mEq Potassium 10 mEq 1000 50 0.75 272 4.5 (3.5 to 6.5) 10 10 170 20 mEq 1000 50 1.5 293 4.5 (3.5 to 6.5) 20 20 170 D-Glucose monohydrate Dextrose is derived from corn. The flexible plastic container is fabricated from a specially formulated nonplasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag).

The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

Structural Formula

💬 Information for Patients 99 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers or home healthcare providers of the following risks of Potassium Chloride in 5% Dextrose Injection: Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] Hyperkalemia [see Warnings and Precautions ( 5.2 )] Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.3 )] Hyponatremia [see Warnings and Precautions ( 5.4 )] Hypokalemia [see Warnings and Precautions ( 5.5 )] Fluid overload [see Warnings and Precautions ( 5.6 )] Refeeding syndrome [see Warnings and Precautions ( 5.7 )] Manufactured for: Lake Zurich, IL 60047 Made in Norway www.fresenius-kabi.com/us 451697 Fresenius Kabi Logo

📖 Instructions for Use ~2 min read ▾

2.3Instructions 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. Check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates.

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.

Suspend solution container from hanger hole. To Add Medication Additives may be incompatible. Complete information is not available.

Do not use additives known or determined to be incompatible. Before adding a substance or medication, verify that it is soluble and/or stable in this drug product and that the pH range of this drug product is appropriate. Consult with pharmacist, if available.

If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique. When introducing additives, consult the instructions for use of the medication to be added and other relevant literature. To Add Medication Prior to Solution Administration 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. Prepare medication site Insert an 18 to 23 gauge needle horizontally through the center of WHITE Additive Port's septum and inject additives.

Mix container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. After addition, check to ensure the solution is clear and there are no precipitates.

Discard if there is a color change and/or the appearance of precipitates. To Add Medication During Solution Administration Close the clamp on the set Identify WHITE Additive Port with arrow pointing toward container Immediately before injecting additives, if the Cap has not been broken off, break off WHITE Additive Port cap with the arrow pointing toward container. Hold base of WHITE Additive Port horizontally.

Prepare medication site. Using a syringe with an 18 to 23 gauge needle, horizontally insert through the center of WHITE Additive Port's septum and inject additives. Remove container from IV pole and/or turn to an upright position.

Mix container contents thoroughly. After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates.

Using aseptic technique, repeat steps 4-7 as necessary. Return container to in use position and continue administration. Storage Use promptly; do not store solutions containing additives.

Single-dose container. Discard any unused portion.

📄 Recent Major Changes 24 words ▾

Contraindications ( 4 ) 07/2019 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) 07/2019

📄 Package Label / Principal Display Panel 218 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose Injection, USP 10 mEq/L Bag Label freeflex NDC 63323- 667 -01 1000 mL 10 mEq Potassium Chloride (10 mEq/L) Potassium Chloride in 5% Dextrose Injection, USP For Intravenous Use. Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose Injection, USP 10 mEq/L Bag Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose Injection, USP 10 mEq/L Shipper Label NDC 63323-667-10 667110 10 mEq Potassium Chloride in 5% Dextrose Injection, USP 1000 mL x 10 PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose Injection, USP 10 mEq/L Shipper Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose Injection, USP 20 mEq/L Bag Label freeflex NDC 63323- 669 -01 1000 mL 20 mEq Potassium Chloride (20 mEq/L) Potassium Chloride in 5% Dextrose Injection, USP For Intravenous Use. Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose Injection, USP 20 mEq/L Bag Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose Injection, USP 20 mEq/L Shipper Label NDC 63323-669-10 669110 20 mEq Potassium Chloride in 5% Dextrose Injection, USP 1000 mL x 10 PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose Injection, USP 20 mEq/L Shipper Label

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Potassium Chloride — the program that covers self-administered drugs. 42 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Potassium Chloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$78.71M
Claims incl. refills
3.7M
Beneficiaries
2.4M
Spend / beneficiary
$33.46
Spend / claim
$21.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J3480 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 63323-0667-10 · Fresenius 63323-0671-00 · 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.