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Potassium Chloride in Sodium 900 mg/100mL; 300 mg/100mL Injection, Solution — NDC 63323-0688-10 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 Sodium 900 mg/100mL; 300 mg/100mL Injection, Solution — NDC 63323-688-10 (Billing 63323-0688-10)

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

This is a package of Potassium Chloride in Sodium 900 mg/100mL; 300 mg/100mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Jun 2021 and currently FDA-listed. It is this product's only package size.

NDC 63323-0688-10
🏷️ FDA NDC (as labeled) 63323-688-10 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 63323-688-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 688 product · 10 package
Package marketed since
Jun 2, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6332368810 3
Medicaid fills, this package
12 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-688-10
Product NDC 63323-688
11-digit billing NDC 63323068810
NCPDP billing unit ML — per mL (volume)
RxCUI 237367, 403890, 637551
UNII 451W47IQ8X, 660YQ98I10
Application # ANDA212347
SPL Set ID c2467d57-cd2d-4409-bcc0-50128bd01bba
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 2021-06-02
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance 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 79992002102030
GCN Seq No 001199
GCN 56591
HICL code 014772
Ingredient (HICL) Potassium Chloride In 0.9%Nacl
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 POTASSIUM CL 40 MEQ/1,000ML-NS
FDB brand name Potassium Chloride-0.9% Nacl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001199
  • GCN: 56591
  • GPI-14 (Medi-Span): 79992002102030
  • HICL (First Databank): 014772
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 237367
Why two NDCs? The FDA registers this code as 63323-688-10 — 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 → 63323-0688-10. 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 Potassium class.

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

Clinical

Label name POTASSIUM CL 40 MEQ/1,000ML-NS Ingredient Potassium Chloride In 0.9%Nacl
📗 Our plain-language guide HelloPharmacist
  • It gives your body water and electrolytes, mainly for hydration. It is also used when a patient needs potassium chloride and sodium chloride through a vein. Your care team picks th...
  • A nurse or doctor gives it as a slow drip into a vein using sterile equipment. It should not be pushed quickly with a syringe. The speed and amount depend on your age, weight, heal...
  • You may have irritation, pain, redness or infection at the IV site, or a fever. Some people feel nausea, vomiting, belly pain or diarrhea. Tell your nurse about any discomfort so t...
  • Tell your nurse immediately if you have chills, trouble breathing, swelling, tingling, muscle weakness, confusion, a slow or irregular heartbeat, severe headache or seizures. These...
📖 Read our full Potassium Chloride / Sodium 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 $0.0097 $97.00 / 10000 ml
Medicare drug plans payPart D · Q2 2026 $0.0096 $96.00 / 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)63323-688-10
11-digit billing NDC63323-0688-10
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 / pkg200 units
How the units are derivedThis package is 1000; the HCPCS unit is 2 MEQ, so one package = 200 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
63323-0688-10 You're viewing this Main listing 10 BAG in 1 CARTON / 1000 mL in 1 BAG 2021-06-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Chloride in Sodium Chloride 900 mg/100mL; 300 mg/100mL 00338-0695-04 Baxter 1000 ml — AP FDA listed —
Potassium Chloride in Sodium Chloride 9 g/1000mL; 2.98 g/1000mL 00990-7116-09 ICU 12 pouches — AP FDA listed —
Potassium Chloride in Sodium Chloride 900 mg/100mL; 300 mg/100mLthis 63323-0688-10 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
Jun 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

🧪 Avoiding an ingredient? See Potassium Chloride / Sodium Chloride inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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 applicationANDA212347 (ANDA)
Labeler code63323
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

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 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

INDICATIONS AND USAGE Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Important Administration Instructions Potassium Chloride in Sodium Chloride Injection, USP is intended for intravenous infusion using sterile equipment. To avoid life threatening hyperkalemia, do not administer Potassium Chloride in Sodium Chloride Injection, USP as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access) without a quantitative infusion device (see WARNINGS ). Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.

Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. Use a dedicated line without any connections to avoid air embolism. Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container.

The choice of a central or peripheral venous route of infusion should depend on the osmolarity of the final infusate. Solutions with osmolarity of greater than or equal to approximately 900 mOsm/L must be infused through a central catheter. Prior to infusion, visually inspect the solution for particulate matter and discoloration.

The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged. Use of final filter is recommended during administration of all parenteral solutions, where possible.

Dosing Information The choice of the specific potassium chloride and sodium chloride formulation, dosage, volume, rate and duration of administration is dependent upon the age, weight and clinical and metabolic condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. Additional electrolyte supplementation may be indicated according to the clinical needs of the patient. Additives can be introduced to the container; however, some additives may be incompatible.

Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique.

After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

Discard any unused portion. Rapid correction of hyponatremia and hypernatremia is potentially dangerous (risk of serious neurologic complications). To avoid complications such as osmotic demyelination syndrome (ODS) during administration, follow the important administration instructions, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.

⛔ Contraindications 30 words ▾

CONTRAINDICATIONS Potassium Chloride in Sodium Chloride Injection, USP is contraindicated in patients with: Known hypersensitivity to potassium chloride and/or sodium chloride (see WARNINGS ). Clinically significant hyperkalemia (see WARNINGS ).

⚠️ Warnings ~2 min read ▾

WARNINGS Hypersensitivity Hypersensitivity and infusion reactions, including anaphylaxis and chills, have been reported with products containing potassium chloride and sodium chloride. Stop the infusion immediately if signs or symptoms of a hypersensitivity or infusion reaction develops. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Electrolyte Imbalances Hyperkalemia Potassium-containing solutions, including Potassium Chloride in Sodium Chloride Injection, USP 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 conduction disorders (including complete heart block) and other cardiac arrhythmias, some fatal, can develop at any time during hyperkalemia.

Continuous electrocardiogram (ECG) monitoring may be necessary to aid in the detection of cardiac arrhythmias due to hyperkalemia (see ADVERSE REACTIONS ). To avoid life threatening hyperkalemia, do not administer Potassium Chloride in Sodium Chloride Injection, USP as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access) without a quantitative infusion device. Patients at increased risk of developing hyperkalemia and cardiac arrhythmias include those: with conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with severe renal impairment, acute dehydration, extensive tissue injury or burns, certain cardiac disorders such as congestive heart failure or atrioventricular (AV) block (especially if they receive digoxin). who are at risk of experiencing 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 ). with cardiac arrhythmias.

Avoid use of Potassium Chloride in Sodium Chloride Injection, USP 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. Hypernatremia and Hyperchloremia Electrolyte imbalances such as hypernatremia, hyperchloremia, and metabolic acidosis may occur with Potassium Chloride in Sodium Chloride Injection, USP.

Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS . Avoid Potassium Chloride in Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia or hyperchloremia.

If use cannot be avoided, monitor serum sodium and chloride concentrations and acid-base balance. Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema.

Hyponatremia Potassium Chloride in Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.

The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmo… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 142 words ▾

ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in Sodium Chloride Injection, USP were identified in clinical trials or postmarketing reports. Because postmarketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. General disorders and administration site condition s: Chills, and infusion site pain.

Hypersensitivity reactions : generalized papules and erythema, rash, fever, vomiting, hypertension, tachycardia. Metabolism and nutrition disorders : Hyperkalemia, hyponatremia, hypernatremia, hyperchloremia acidosis, fluid overload. Cardiac disorders : Cardiac arrest as a manifestation of rapid intravenous administration and/or of hyperkalemia.

Nervous System Disorders : Hyponatremic encephalopathy. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

🔄 Drug Interactions ~1 min read ▾

Drug Interactions Lithium Renal sodium and lithium clearance may be increased during administration of Potassium Chloride in Sodium Chloride Injection, USP and result in decreased lithium concentrations. Monitor serum lithium concentrations during concomitant use. Other Products that Cause Hyperkalemia Administration of Potassium Chloride in Sodium Chloride Injection, USP in patients treated concurrently or recently with products that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia.

Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients receiving such products (e.g., potassium sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or the immunosuppressants cyclosporine and tacrolimus). If use cannot be avoided, monitor serum potassium concentrations. Other Products that Affect Fluid and/or Electrolyte Balance Administration of Potassium Chloride in Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload.

Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance, and acid-base balance. Other Drugs that Increase the Risk of Hyponatremia Administration of Potassium Chloride in Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.

Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

🤰 Pregnancy 91 words ▾

Pregnancy There are no adequate and well controlled studies from the use of Potassium Chloride in Sodium Chloride Injection, USP in pregnant or lactating women and animal reproduction studies have not been conducted with this drug. Therefore, it is also not known whether Potassium Chloride in Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in Sodium Chloride Injection, USP should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 71 words ▾

Pediatric Use The use of Potassium Chloride in Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See DOSAGE AND ADMINISTRATION ). Safety and effectiveness of Potassium Chloride in Sodium Chloride Injection, USP in pediatric patients have not been established by adequate and well-controlled studies.

Pediatric patients are at increased risk of developing hyponatremia as well as for developing encephalopathy as a complication of hyponatremia (see WARNINGS ).

🧓 Geriatric Use 92 words ▾

Geriatric Use Geriatric patients are at increased risk of developing electrolyte imbalances. Potassium Chloride in Sodium Chloride Injection, USP is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Consider monitoring renal function in elderly patients.

🆘 Overdosage 203 words ▾

OVERDOSAGE An increased infusion rate of Potassium Chloride in Sodium Chloride Injection, USP can cause: hyperkalemia, manifestations may include disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation. 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.

Muscle weakness (up to and including muscular and respiratory paralysis, paresthesia of extremities) may occur as a complication of hyperkalemia. hyponatremia, manifestations may include seizures, coma, cerebral edema and death. hypernatremia, especially in patients with severe renal impairment. hypotension. gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain). fluid overload (which can lead to central and/or peripheral edema). See WARNINGS and ADVERSE REACTIONS . When assessing an overdose, any additives in the solution must also be considered.

The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of Potassium Chloride in Sodium Chloride Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid-base balance).

🧬 Clinical Pharmacology 32 words ▾

CLINICAL PHARMACOLOGY Potassium Chloride in Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

📦 How Supplied / Storage and Handling 165 words ▾

HOW SUPPLIED Potassium Chloride in Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows: Product Code Unit of Use Strength Unit of Sale 683110 NDC 63323-683-01 One 1000 mL free flex ® bag 20 mEq Potassium Chloride in 0.45% Sodium Chloride NDC 63323-683-10 Package of 10 free flex ® bags 686110 NDC 63323-686-01 One 1000 mL free flex ® bag 20 mEq Potassium Chloride in 0.9% Sodium Chloride NDC 63323-686-10 Package of 10 free flex ® bags 688110 NDC 63323-688-01 One 1000 mL free flex ® bag 40 mEq Potassium Chloride in 0.9% Sodium Chloride NDC 63323-688-10 Package of 10 free flex ® bags Exposure of pharmaceutical products to heat should be minimized.

Avoid excessive heat. It is recommended the product be stored between 20ºC to 25°C (68º F to 77°F). [See USP controlled room temperature.]; brief exposure up to 40°C (104°F) does not adversely affect the product. The container closure is not made with natural rubber latex.

Non-PVC, Non-DEHP, Sterile.

📋 Description ~1 min read ▾

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

Table 1 *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. Size (mL) Composition (g/L) *Osmolarity (mOsmol/L) (Calc.) pH Ionic Concentration (mEq/L) Sodium Chloride, USP NaCl Potassium Chloride, USP KCl Sodium Potassium Chloride 20 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP 1000 4.5 1.5 194 5.5 (3.5 to 6.5) 77 20 97 20 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP 1000 9 1.5 348 5.5 (3.5 to 6.5) 154 20 174 40 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP 1000 9 3 388 5.5 (3.5 to 6.5) 154 40 194 The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag).

The amount of water that can permeate from 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.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Patients with Severe Renal Impairment Administration of sodium and potassium in patients with or at risk of severe renal impairment, may result in hypernatremia, hyperkalemia and/or fluid overload (see WARNINGS ). Avoid Potassium Chloride in Sodium Chloride Injection, USP in patients with severe renal impairment. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.

Drug Interactions Lithium Renal sodium and lithium clearance may be increased during administration of Potassium Chloride in Sodium Chloride Injection, USP and result in decreased lithium concentrations. Monitor serum lithium concentrations during concomitant use. Other Products that Cause Hyperkalemia Administration of Potassium Chloride in Sodium Chloride Injection, USP in patients treated concurrently or recently with products that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia.

Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients receiving such products (e.g., potassium sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or the immunosuppressants cyclosporine and tacrolimus). If use cannot be avoided, monitor serum potassium concentrations. Other Products that Affect Fluid and/or Electrolyte Balance Administration of Potassium Chloride in Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload.

Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance, and acid-base balance. Other Drugs that Increase the Risk of Hyponatremia Administration of Potassium Chloride in Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.

Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

Pregnancy There are no adequate and well controlled studies from the use of Potassium Chloride in Sodium Chloride Injection, USP in pregnant or lactating women and animal reproduction studies have not been conducted with this drug. Therefore, it is also not known whether Potassium Chloride in Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in Sodium Chloride Injection, USP should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Potassium Chloride in Sodium Chloride Injection, USP is administered to a nursing mother. Pediatric Use The use of Potassium Chloride in Sodium Chloride Injection, USP in pediatric patients is based on clinical practice.

(See DOSAGE AND ADMINISTRATION ). Safety and effectiveness of Potassium Chloride in Sodium Chloride Injection, USP in pediatric patients have not been established by adequate and well-controlled studies. Pediatric patients are at increased risk of developing hyponatremia as well as for developing encephalopathy as a complication of hyponatremia (see WARNINGS ).

Geriatric Use Geriatric patients are at increased risk of developing electrolyte imbalances. Potassiu… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 40 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Potassium Chloride in Sodium Chloride Injection, USP is administered to a nursing mother.

📖 Instructions for Use ~2 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. 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. 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. 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. Using aseptic technique, repeat steps 4-7 as necessary.

Return container to in use position and continue administration. WARNING: Do not use flexible container in series connections. Manufactured for: Lake Zurich, IL 60047 Made in Norway www.fresenius-kabi.com/us 451701 Issued: February 2021 Fresenius Kabi Logo

📄 Package Label / Principal Display Panel 180 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 0.45% Sodium Chloride Injection, USP Bag Label free flex ® NDC 63323- 683 -01 1000 mL 20 mEq Potassium Chloride (20 mEq/L) Potassium Chloride in 0.45% Sodium Chloride Injection, USP For Intravenous Use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 0.45% Sodium Chloride Injection, USP Bag Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 0.9% Sodium Chloride Injection, USP Bag Label free flex ® NDC 63323- 686 -01 1000 mL 20 mEq Potassium Chloride (20 mEq/L) Potassium Chloride in 0.9% Sodium Chloride Injection, USP For Intravenous Use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 0.9% Sodium Chloride Injection, USP Bag Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 0.9% Sodium Chloride Injection, USP Bag Label free flex ® NDC 63323- 688 -01 1000 mL 40 mEq Potassium Chloride (40 mEq/L) Potassium Chloride in 0.9% Sodium Chloride Injection, USP For Intravenous Use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 0.9% Sodium Chloride Injection, USP Bag Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
12
Units reimbursed last 4 qtrs
20K
Gross reimbursed last 4 qtrs
$194.67
Avg / prescription
$16.22
Avg / unit
$0.0097
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 12 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 20,000 units · 170 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
170170
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Ohio 170 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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) ✓ Available
“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.
← 63323-0686-10 · Fresenius 63323-0690-30 · 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.