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Potassium Chloride in Lactated Ringers and Dextrose DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM 5 g/100mL; 600 mg/100mL; 310 mg/100mL; 179 mg/100mL; 20 mg/100mL Injection, Solution, 1000 mL — NDC 0338-0811-04 (Billing 00338-0811-04)

by Baxter Healthcare Corporation · 1000 mL in 1 BAG

This is a package of 1,000 mL of Potassium Chloride in Lactated Ringers and Dextrose DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM 5 g/100mL; 600 mg/100mL; 310 mg/100mL; 179 mg/100mL; 20 mg/100mL Injection, Solution from Baxter Healthcare Corporation, marketed since Apr 1985 and currently FDA-listed. It is this product's only package size.

NDC 00338-0811-04
🏷️ FDA NDC (as labeled) 0338-0811-04 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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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) 0338-0811-04
Product NDC 0338-0811
11-digit billing NDC 00338081104
NCPDP billing unit ML — per mL (volume)
RxCUI 847626
UNII LX22YL083G, 451W47IQ8X, TU7HW0W0QT, 660YQ98I10, M4I0D6VV5M
Application # NDA019367
SPL Set ID 05f326e6-10e4-4ceb-8a23-f53c592f00b8
Established class (EPC) Blood Coagulation Factor; Cations; Inhibition Larg
Physiologic effect Increased Coagulation Factor Activity; Increased Large Intestinal Motility
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1985-04-05
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE

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

GCN Seq No 002024
GCN 28750
HICL code 014783
Ingredient (HICL) Potassium Chloride In Lr-D5
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 IN D5W-LACT RINGER
FDB brand name Potassium Chloride In D5Lr
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002024
  • GCN: 28750
  • HICL (First Databank): 014783
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 847626
Why two NDCs? The FDA registers this code as 0338-0811-04 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00338-0811-04. 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 Organic acids class.

Drug family (ATC) Organic acids
How it works Acidifying Activity
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 IN D5W-LACT RINGER Ingredient Potassium Chloride In Lr-D5
📗 Our plain-language guide HelloPharmacist
  • This IV solution is replacing fluids and important minerals your body needs to function — things like sodium, potassium, calcium, and chloride. It also contains dextrose (a simple...
  • Why am I being given this IV drip — what is it actually doing for me?
  • Yes, some redness, mild pain, burning, or swelling at the IV site is one of the more common things people notice. Itching or a rash there can also happen. Let your nurse know right...
  • Is it normal to feel some discomfort where the IV goes in?
📖 Read our full Calcium Chloride / Dextrose / Potassium Chloride / Sodium Chloride / Sodium Lactate 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 $0.0120 $12.00 / 1000 ml
Medicare Part B allowsASP · J7121 No ASP payment limit on file for J7121 this quarter.
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)0338-0811-04
11-digit billing NDC00338-0811-04
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7121
Descriptor5% DEXTROSE IN LACTATED RINGERS INFUSION, UP TO 1000 CC
Billing units / pkg0 units
How the units are derivedThis package is 1000 ML; the HCPCS unit is 1000 ML, so one package = 0 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
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
00338-0811-04 You're viewing this Main listing 1000 mL in 1 BAG 1985-04-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Chloride in Lactated Ringers and Dextrose 5 g/100mL; 600 mg/100mL; 310 mg/100mL; 179 mg/100mL; 20 mg/100mLthis 00338-0811-04 Baxter 1000 ml — — FDA listed —
Potassium Chloride in Lactated Ringers and Dextrose 1.79 g/1000mL; 6 g/1000mL; .2 g/1000mL; 3.1 g/1000mL; 50 g/1000mL 00990-7111-09 ICU 12 pouches — — FDA listed —
Potassium Chloride in Lactated Ringers and Dextrose 1.79 g/1000mL; 6 g/1000mL; .2 g/1000mL; 3.1 g/1000mL; 50 g/1000mL 65219-0246-10 Fresenius 1000 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1985
On the market since
Apr 1985
📍
2026
Currently FDA-listed
41 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA019367 (NDA)
Labeler code00338
First marketedApr 1985
Product typeHuman Prescription Drug
Portfolio283 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 69 words ▾

1 INDICATIONS AND USAGE Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients. Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • The recommended dosage and duration are based on the patient’s age, weight, clinical condition, and concomitant therapy. ( 2.1 ) • To reduce the risk of air embolism, adhere to the preparation instructions. ( 2.2 , 5.2 ) • Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is for intravenous use.

( 2.3 ) • Use a peripheral vein to administer if the final dextrose concentration is 5% or less, and the osmolarity is less than 900 mOsm/L. ( 2.3 ). • Consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or more to avoid venous irritation, including phlebitis. ( 2.3 ) • Do not administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) due to serious risks.

( 2.4 ) • See full prescribing information for information dosage considerations, preparation, administration, and drug incompatibilities. ( 2 )

2.1Dosage Considerations The recommended dosage and duration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is based on the patient’s age, weight, clinical condition, and concomitant therapy. Evaluate the patient’s clinical status and monitor changes in blood glucose and electrolyte concentrations especially during prolonged use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to optimize clinical status.

2.2Important Preparation Instructions Visually inspect the Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection solution for particulate matter and discoloration. Do not administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection unless the solution is clear and the container seals are intact. If additives are determined to be compatible with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection then using aseptic technique, mix thoroughly; do not store solutions containing additives.

After mixing, do not use if there is discoloration or formation of precipitates. To reduce the risk of air embolism, adhere to the following preparation instructions for Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection [see Warnings and Precautions (5.2) ] : • Use a non-vented infusion set or close the vent on a vented set. • Use a dedicated line without any connections (do not connect flexible containers in series). • The use of pressure infusion is not recommended as a method to increase flow rates.

However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion. • If using a pumping device to administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, turn off the pump before the container is empty. Preparation Instructions 1. Tear overwrap downside at slit and remove solution container.

2. Visually inspect the container. o If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. o Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually. 3. Check for minute leaks by squeezing inner bag firmly.

If leaks are found, discard solution as sterility may be impaired. 4. If supplemental medication is desired, follow directions below [see Dosage and Administration (2.3) ] .

Preparation for Administration 1. Suspend container from eyelet support. 2.

Remove protector from outlet port at bottom of container. 3. Attach administration set according to its accompanying directions.

2.3Important Administration Instructions Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is for intravenous use. Use immediately after removing the overwrap. Discard the unused portion. • Use a peripheral vein to administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%)… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 59 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: Potassium Chloride (20 mEq) in Lactated Ringer’s and Dextrose (5%) Injection, USP as a clear, sterile, and nonpyrogenic solution packaged in a single-dose VIAFLEX plastic container: 1,000 mL. Injection: Potassium Chloride (20 mEq) in Lactated Ringer’s and Dextrose (5%) Injection, USP packaged in a single-dose VIAFLEX plastic container: 1000 mL. ( 3 )

⛔ Contraindications 172 words ▾

4 CONTRAINDICATIONS Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in: • Neonates (28 days of age or younger) who are receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.1) and Specific Populations (8.4) ] . • Patients with known hypersensitivity to any of the components of Potassium Chloride in Lactated Ringer’s solution and Dextrose (5%) Injection [see Warnings and Precautions (5.3) ] . • Patients with clinically significant hyperkalemia [see Warnings and Precautions (5.4) ] . • Patients with clinically significant hyperglycemia [see Warnings and Precautions (5.7) ] . • Concomitant treatment with ceftriaxone in neonates (28 days of age or younger).

( 4 ) • Patients with known hypersensitivity to any of the components of Potassium Chloride in Lactated Ringer’s solution and Dextrose (5%) Injection ( 4 ) • Patients with clinically significant hyperkalemia ( 4 ). • Patients with clinically significant hyperglycemia ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Serious Risks with Inappropriate Use with Ceftriaxone : Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone. In patients older than 28 days, ceftriaxone and Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions. ( 4 , 5 .

1 , 8.4 ) • Air Embolism : Use a non-vented infusion set or close the vent on a vented set and use a dedicated line without any connections. Pressure infusion is not recommended to increase flow rates, but if necessary, remove all air from the bag prior to initiating infusion. ( 5.2 ) • Hypersensitivity Reactions : Stop the Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection infusion immediately if signs or symptoms of a hypersensitivity reaction develop.

( 5.3 ) • Potassium Imbalances, Hyponatremia, Neonatal Hypoglycemia, Hyperglycemia and Hyperosmolar Hyperglycemic State, Hypercalcemia, Fluid Overload, Acid-Base Imbalances, Interference with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis: See Full Prescribing Information for risk management recommendations. ( 5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11 )

5.1Serious Risk with Concomitant Use with Ceftriaxone Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, in the same intravenous administration line. Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used.

Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in neonates who receive ceftriaxone [see Contraindications (4) , Use in Specific Populations (8.4) ] . However, in patients older than 28 days, ceftriaxone and Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid.

5.2Air Embolism Cases of air embolism have been reported with pressurized administration of intravenous fluids. Air embolism may result in stroke, organ ischemia and/or infarction, and death. Use a non-vented infusion set or close the vent on a vented set and use a dedicated line without any connections.

If administration is controlled by a pumping device, care must be taken to discontinue the pumping action before the container is empty. If administration is controlled by a pumping device, care must be taken to discontinue the pumping action before the container is empty. Pressure infusion is not recommended to increase flow rates, but if necessary, ensure all air is removed from the bag before infusion.

Refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container [see Dosage and Administration (2.2) ] .

5.3Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Lactated Ringer’s solution. Stop the Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

5.4Potassium Imbalances Hyperkalemia Potassium-containing solutions, including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, may increase the risk of hyperkalemia. This risk is increased in patients predisposed to hyperkalemia including those with severe renal impairment, acute dehydration, extensive tissue injury or burns, heart failure,… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Serious Risk with Concomitant Use with Ceftriaxone [see Warnings and Precautions (5.1) ] • Air Embolism [see Warnings and Precautions (5.2) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] • Potassium Imbalances [see Warnings and Precautions (5.4) ] • Hyponatremia [see Warnings and Precautions (5.5) ] • Neonatal Hypoglycemia [see Warnings and Precautions (5.6) ] • Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.7) ] • Hypercalcemia [see Warnings and Precautions (5.8) ] • Fluid Overload [see Warnings and Precautions (5.9) ] • Acid/Base Imbalances [see Warnings and Precautions (5.10) ] The following adverse reactions have been identified during postapproval use of Lactated Ringer’s products.

Because these reactions are 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: General Disorders and Administration Site Conditions: Phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, and infusion site hypoaesthesia. Hypersensitivity Reactions and Infusion Reactions: Angioedema, chest pain/discomfort, bradycardia or tachycardia, hypotension, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, oral hypoesthesia, dysgeusia, nausea, anxiety, pyrexia, and headache, laryngeal edema, sneezing, injection site infection.

Metabolism and Nutrition Disorders: Hyperkalemia, hyponatremia, and hypervolemia. Nervous System Disorders: Hyponatremic encephalopathy. Common adverse reactions include infusion site reactions and symptoms of hypersensitivity reactions (e.g., pruritus, dyspnea, urticaria, rash, cough).

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • Drugs that Affect Electrolyte and/or Fluid Balance : Avoid concomitant use. If concomitant use cannot be avoided, closely monitor electrolyte concentrations and fluid balance. ( 7.1 ) • Lithium : Avoid concomitant use.

If concomitant use is unavoidable, monitor serum lithium concentrations more frequently. ( 7.2 ) • Digoxin : Consider reducing the volume or rate of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection due to the increased risk of digoxin toxicity with calcium-containing solutions. ( 7.3 ) • Drugs with pH-Dependent Renal Elimination : Renal clearance of acidic drugs may be increased.

In contrast, renal clearance of alkaline drugs may be decreased. ( 7.4 )

7.1Drugs that Affect Electrolyte and/or Fluid Balance Hyperkalemia Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients concomitantly treated or recently treated with drugs that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, especially in the presence of other hyperkalemia risk factors. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving drugs that are associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or calcineurin inhibitors).

If concomitant use cannot be avoided, closely monitor serum potassium concentrations during concomitant use [see Warnings and Precautions (5.4) ]. Hyponatremia Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia. These drugs include diuretics and those that cause SIADH (e.g., arginine vasopressin analogs, certain antiepileptic, psychotropic, or cytotoxic drugs).

Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5) ]. Hypercalcemia Avoid the use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients treated with thiazide diuretics or vitamin D because these drugs can increase the risk of hypercalcemia.

If use cannot be avoided, closely monitor serum calcium concentrations during concomitant use [see Warnings and Precautions (5.8) ]. Hypernatremia and Fluid Retention Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients treated concomitantly with drugs associated with sodium and fluid retention (e.g., corticosteroids or corticotropin) may increase the risk of hypernatremia and volume overload. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving such drugs.

If use cannot be avoided, closely monitor serum electrolytes, fluid balance, and acid-base balance during concomitant use.

7.2Lithium Renal sodium and lithium clearance may be increased during concomitant use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection and lithium and may result in decreased lithium concentrations. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving lithium. If use cannot be avoided, increase the frequency of monitoring of serum lithium concentrations during concomitant use.

7.3Digoxin Administration of calcium via use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may increase digoxin’s effects and lead to digoxin toxicity including serious or fatal cardiac arrhythmias. In digoxin-treated patients, consider reducing the volume and/or rate of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection administration.

7.4Drugs with pH-Dependent Renal Elimination Due to the alkalinizing action of lactate (formation of bicarbonate), Potassium Chloride… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function. ( 8.4 ) • Neonates are at increased risk of developing hypo- or hyperglycemia. Closely monitor to ensure adequate glycemic control.

( 8.4 ) • Geriatric patients are more likely to have decreased renal function. Consider monitoring renal function and starting the infusion at the low end of the dosing range. ( 8.5 ) • Avoid in patients with severe renal impairment.

( 8.6 ) • Patients with severe hepatic impairment may have impaired lactate metabolism. Closely monitor serum lactate levels and acid-base status. ( 8.7 )

8.1Pregnancy Risk Summary Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection as a source of water and electrolytes has been used for decades during labor and delivery. Appropriate administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with this drug.

The 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 Lactated Ringer’s as a source of water and electrolytes and Dextrose (5%) Injection have been used for decades and is not expected to cause harm to a breastfed infant. There are no data on the presence of Lactated Ringer’s and Dextrose (5%) Injection in human milk, the effects on the breastfed infant, or the effects on milk production. Potassium is present in human breast milk.

There are no data on the effects of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) 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 Lactated Ringer’s and Dextrose (5%) Injection and any potential adverse effects on the breastfed infant from Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection or from the underlying maternal condition.

8.4Pediatric Use Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in neonates (28 days of age or younger) who are receiving ceftriaxone due to reported deaths that occurred when neonates received ceftriaxone and intravenous calcium-containing solutions concomitantly [see Warnings and Precautions (5.1) ]. The safety and effectiveness of Lactated Ringer’s Injection for use as a source of water, electrolytes, and calories or as an alkalinizing agent have been established in pediatric patients of all ages, including neonates.

The safety profile of Potassium Chloride in Dextrose Injection in pediatric patients is similar to adults. Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function who may have decreased ability to maintain fluid and electrolyte balance [see Warnings and Precautions (5.4 , 5.5 , 5.8 , 5.9 )]. Administration of a lactate-containing intravenous solution, including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to pediatric patients should account for liver and kidney maturation (the kidney function affects the biotransformation and renal excretion of lactate) [see Warnings and Precautions (5.9) ].

Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions including Potassiu… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 123 words ▾

8.1Pregnancy Risk Summary Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection as a source of water and electrolytes has been used for decades during labor and delivery. Appropriate administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with this drug.

The 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 ~1 min read ▾

8.4Pediatric Use Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in neonates (28 days of age or younger) who are receiving ceftriaxone due to reported deaths that occurred when neonates received ceftriaxone and intravenous calcium-containing solutions concomitantly [see Warnings and Precautions (5.1) ]. The safety and effectiveness of Lactated Ringer’s Injection for use as a source of water, electrolytes, and calories or as an alkalinizing agent have been established in pediatric patients of all ages, including neonates.

The safety profile of Potassium Chloride in Dextrose Injection in pediatric patients is similar to adults. Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function who may have decreased ability to maintain fluid and electrolyte balance [see Warnings and Precautions (5.4 , 5.5 , 5.8 , 5.9 )]. Administration of a lactate-containing intravenous solution, including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to pediatric patients should account for liver and kidney maturation (the kidney function affects the biotransformation and renal excretion of lactate) [see Warnings and Precautions (5.9) ].

Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to ensure adequate glycemic control to avoid potential long-term adverse reactions [see Warnings and Precautions (5.6 , 5.7 )].

In very low birth weight neonates, excessive or rapid administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may result in increased serum osmolarity and risk of intracranial hemorrhage.

🧓 Geriatric Use 101 words ▾

8.5Geriatric Use Geriatric patients treated with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection are at increased risk of developing electrolyte imbalances. Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is substantially excreted by the kidney, and the risk of adverse reactions to Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may be greater in patients with renal impairment than in patients with normal renal function. Because geriatric patients are more likely to have decreased renal function, consider monitoring renal function in geriatric patients and consider starting the infusion at the low end of the dosing range.

🆘 Overdosage 112 words ▾

10 OVERDOSAGE Excessive administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection can cause: • Hyperkalemia and hypernatremia, especially in patients with severe renal impairment. • Fluid overload (which can lead to pulmonary and/or peripheral edema). • Hyperglycemia, hyperosmolarity, and osmotic diuresis, dehydration, and electrolyte loss. • Metabolic alkalosis with or without hypokalemia. • Loss of bicarbonate with an acidifying effect. • Hypercalcemia. Overdose interventions include Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection discontinuation, treatment of electrolyte imbalances, treatment of hyperglycemia, and close monitoring of fluid balance, electrolyte concentrations, and acid-base balance [see Warnings and Precautions (5.4 , 5.5 , 5.6 , 5.7 , 5.9 , 5.10 )]

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is a source of water, electrolytes, and calories, and produces an alkalinizing effect. • Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. • Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. • Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration. • Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate.

In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability. • Sodium lactate provides sodium and lactate ions. The lactate anion is in equilibrium with pyruvate and has an alkalinizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. The sodium ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). • Dextrose provides a source of calories.

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

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection have not been fully characterized.

12.3Pharmacokinetics Elimination Metabolism/Excretion Potassium: Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder is excreted in feces and to a smaller extent, in perspiration. Sodium and Chloride: 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. Lactate: In the liver, lactate is metabolized to carbon dioxide and water by oxidative metabolism and consumption of hydrogen cations.

Dextrose: Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is a source of water, electrolytes, and calories, and produces an alkalinizing effect. • Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. • Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. • Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration. • Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate.

In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability. • Sodium lactate provides sodium and lactate ions. The lactate anion is in equilibrium with pyruvate and has an alkalinizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. The sodium ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). • Dextrose provides a source of calories.

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

📦 How Supplied / Storage and Handling 103 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, USP is supplied as a clear solution in single-dose VIAFLEX plastic containers as follows: Code Size (mL) NDC Product Name 2B2224 1000 0338-0811-04 20 mEq/L Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP Storage and Handling Store at room temperature (recommended 25°C/77°F). Brief exposure up to 40°C (104°F) does not adversely affect the product. Exposure to heat should be minimized.

Avoid excessive heat. Baxter Healthcare Corporation Deerfield, IL 60015 USA Baxter, PL 146 and Viaflex are trademarks of Baxter International Inc. or its subsidiaries. 07-19-00-9427

📋 Description ~1 min read ▾

11 DESCRIPTION Potassium Chloride in Lactated Ringer’s and Dextrose (5%) 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 .

Dextrose is derived from corn. Table 1 Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, USP Size (mL) Composition (g/L) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) Dextrose, USP Sodium Chloride, USP Sodium Lactate Potassium Chloride, USP Calcium Chloride, USP Sodium Potassium Calcium Chloride Lactate 20 mEq Potassium added 1000 50 6 3.1 1.79 0.2 565 5.0 (3.5 to 6.5) 130 24 3 129 28 170 The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2 .

Table 2 Chemical Name Structural Formula Molecular Weight Sodium Chloride, USP

58.44Sodium Lactate 112.06 Potassium Chloride, USP

74.55Calcium Chloride, USP 147.02 Dextrose, USP 198.17 The VIAFLEX plastic container is fabricated from polyvinyl chloride (PL 146 Plastic). Small amounts of its chemical components (e.g., di-2-ethylhexyl phthalate [DEHP]) may leach out within the expiration period. Animal tests, USP biological tests for plastic containers, and tissue culture toxicity studies have demonstrated that the container meets safety requirements.

The container is overwrapped to provide protection from the physical environment and an additional moisture barrier. Sodium Chloride Structural Formula Sodium Lactate Structural Formula Potassium Chloride Structural Formula Calcium Chloride Structural Formula Dextrose Structural Formula

🧬 Pharmacokinetics 92 words ▾

12.3Pharmacokinetics Elimination Metabolism/Excretion Potassium: Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder is excreted in feces and to a smaller extent, in perspiration. Sodium and Chloride: 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. Lactate: In the liver, lactate is metabolized to carbon dioxide and water by oxidative metabolism and consumption of hydrogen cations.

Dextrose: Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.

🧬 Pharmacodynamics 31 words ▾

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection have not been fully characterized.

🧪 Nonclinical Toxicology 30 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genetic toxicology, and animal fertility studies have not been conducted with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 27 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genetic toxicology, and animal fertility studies have not been conducted with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection.

📄 Recent Major Changes 45 words ▾

Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 ) 10/2025 Contraindications ( 4 ) 10/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11 ) 10/2025

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label LOT EXP 2B2224 NDC 0338-0811-04 DIN 00786314 20 mEq Potassium Chloride (20 mEq/L) Potassium Chloride in Lactated Ringer's and 5% Dextrose Injection USP 1000 mL EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP 600 mg SODIUM CHLORIDE USP 310 mg SODIUM LACTATE 179 mg POTASSIUM CHLORIDE USP 20 mg CALCIUM CHLORIDE USP pH 5.0 (3.5 TO 6.5) mEq/L SODIUM 130 POTASSIUM 24 CALCIUM 3 CHLORIDE 129 LACTATE 28 HYPERTONIC OSMOLARITY 565 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD DO NOT USE UNLESS SOLUTION IS CLEAR Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT VIAFLEX PLUS CONTAINER PL 146 PLASTIC BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC FOR PRODUCT INFORMATION 1-800-933-0303 Baxter BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA DISTRIBUTED IN CANADA BY BAXTER CORPORATION TORONTO ONTARIO CANADA Representative Container Label

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

About this NDC listing & data coverage

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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 Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation 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 J7121 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.
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Where does this data come from?
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← 00338-0807-04 · Baxter 00338-0822-10 · Baxter →
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.