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Potassium Chloride 20 meq/15mL Solution, 473 mL — NDC 00121-0948-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Potassium Chloride 20 meq/15mL Solution, 473 mL — NDC 0121-0948-16 (Billing 00121-0948-16)

by PAI Holdings, LLC dba PAI Pharma · 473 mL in 1 BOTTLE

This is a package of 473 mL of Potassium Chloride 20 meq/15mL Solution from PAI Holdings, LLC dba PAI Pharma, marketed since Mar 2023 and currently FDA-listed; retail pharmacies pay about $0.0409 per mL (NADAC). It is this product's only package size.

NDC 00121-0948-16
🏷️ FDA NDC (as labeled) 0121-0948-16 billing pads the labeler 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 Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Potassium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Oct 29, 2025 — Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq (Otsuka ICU Medical LLC) · FDA recall D-0181-2026
Class I · Oct 29, 2025 — Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq (Otsuka ICU Medical LLC) · FDA recall D-0180-2026
Class I · Feb 13, 2025 — Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq (ICU Medical, Inc.) · FDA recall D-0268-2025
Class I · Feb 13, 2025 — Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container. (ICU Medical, Inc.) · FDA recall D-0267-2025
Class II · Jan 30, 2025 — Failed Dissolution Specifications. (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) · FDA recall D-0221-2025
Class I · Jun 25, 2024 — Failed Dissolution Specifications (Amerisource Health Services LLC) · FDA recall D-0619-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0121-0948-16
Product NDC 0121-0948
11-digit billing NDC 00121094816
NCPDP billing unit ML — per mL (volume)
RxCUI 312515, 314182
UNII 660YQ98I10
Application # ANDA210766
SPL Set ID e848477f-b10d-4249-b322-b70cd6a062de
Established class (EPC) Osmotic Laxative; Potassium Salt
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
Chemical class Potassium Compounds
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-27
Route ORAL
Dosage form SOLUTION
Substance POTASSIUM CHLORIDE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 79700030002085
GCN Seq No 001264
GCN 03443
HICL code 000549
Ingredient (HICL) Potassium Chloride
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 10% (20 MEQ/15ML)
FDB brand name Potassium Chloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001264
  • GCN: 03443
  • GPI-14 (Medi-Span): 79700030002085
  • HICL (First Databank): 000549
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 312515
Why two NDCs? The FDA registers this code as 0121-0948-16 — 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 → 00121-0948-16. 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 10% (20 MEQ/15ML) Ingredient Potassium Chloride
📗 Our plain-language guide HelloPharmacist
  • It treats and prevents low potassium. Doctors often use it when you take diuretics or lose fluids through diarrhea or vomiting and food alone isn't enough. The injection is used in...
  • Take tablets and capsules with meals, not on an empty stomach, to protect your stomach. Powders and liquids need to be diluted first. Follow your prescriber's directions and keep y...
  • The most common issue is stomach upset. Taking it with food helps. Call your doctor if you have severe vomiting, belly pain, swelling or bleeding, since that can mean an ulcer or b...
  • Check with me first. Blood pressure medicines such as ACE inhibitors and ARBs, spironolactone, and NSAIDs can raise potassium. Triamterene and amiloride should be avoided with it.
📖 Read our full Potassium Chloride guide →
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 $0.041 $19.35 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0695 $32.87 / 473 ml
Medicare drug plans payPart D · Q2 2026 $0.0928 $43.89 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.075 $0.038
▼ Down 26% over the last 13 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00121-0948-16 You're viewing this Main listing 473 mL in 1 BOTTLE 2023-03-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Chloride 20 meq/15mLthis 00121-0948-16 PAI 473 ml $0.041 AA Availability likely —
Potassium Chloride 20 meq/15mL 00603-1542-58 Endo 473 ml $0.041 AA Discontinued —
Potassium Chloride 20 meq/15mL 59651-0959-47 Aurobindo 473 ml $0.041 AA Availability likely —
Potassium Chloride 1.5 g/15mL 69238-1459-02 Amneal 473 ml $0.041 AA Availability likely —
Potassium Chloride 20 meq/15mL 70010-0072-44 Granules 473 ml $0.041 AA Availability likely —
Potassium Chloride 20 meq/15mL 72888-0041-13 Advagen 473 ml $0.041 AA Availability likely —
Potassium Chloride 20 meq/15mL 43386-0168-01 Lupin 473 ml $0.084 AA FDA listed +105%
Potassium Chloride 20 meq/30mL 00121-1896-00 PAI 10 cups — AA FDA listed —
Potassium Chloride 20 meq/15mL 00121-4948-00 PAI 10 cups — AA FDA listed —
Potassium Chloride 20 meq/15mL 00904-7461-46 Major 30 cups — AA FDA listed —
Potassium Chloride 40 meq/30mL 00904-7462-43 Major 50 cups — AA FDA listed —
Potassium Chloride for Oral Solution 1.5 g/1.58g 10135-0819-08 Marlex 1.58 g — AA FDA listed —
Potassium Chloride 1.5 g/15mL 17856-0048-01 ATLANTIC 72 cups — AA FDA listed —
Potassium Chloride 20 meq/15mL 27808-0168-01 Tris 473 ml — — FDA listed —
Potassium chloride 20 meq/15mL 31722-0494-47 Camber 473 ml — AA FDA listed —
Potassium Chloride 20 meq/15mL 33342-0511-73 Macleods 473 ml — AA FDA listed —
Potassium Chloride 40 meq/30mL 43598-0160-01 Dr. 100 cups — AA FDA listed —
Potassium Chloride 20 meq/15mL 43598-0891-10 Dr. 100 cups — AA FDA listed —
Potassium Chloride 1.5 g/15mL 50268-0674-15 AvPAK 50 cups — AA FDA listed —
Potassium Chloride 20 meq/15mL 53041-0681-06 Guardian 473 ml — AA FDA listed —
Potassium Chloride 20 meq/15mL 54288-0160-47 BPI 473 ml — AA FDA listed —
Potassium Chloride 1.5 g/15mL 60687-0628-07 American 10 cups — AA Discontinued —
Potassium Chloride 1.5 g/15mL 60687-0884-07 American 10 cups — AA FDA listed —
Potassium Chloride 20 meq/15mL 63739-0724-50 McKesson 10 cups — AA Discontinued —
Potassium Chloride 20 meq/15mL 64950-0320-99 Genus 113562 ml — AA Discontinued —
Potassium Chloride 1.5 g/15mL 71656-0021-01 Saptalis 10 cups — AA FDA listed —
Potassium Chloride 1.5 g/15mL 81033-0220-51 Kesin 10 cups — AA FDA listed —
Potassium Chloride 3 g/30mL 81033-0240-50 Kesin 10 cups — AA FDA listed —
Potassium Chloride 20 meq/15mL 82983-0411-47 Ajenat 473 ml — AA 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

Color white / orange
FlavorOrange
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPAI Holdings, LLC dba PAI Pharma
Application holderPHARMACEUTICAL ASSOCIATES INC
FDA applicationANDA210766 (ANDA)
Labeler code00121
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio142 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. 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 📦 Storage and Handling 📋 Description 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 66 words ▾

1 INDICATIONS AND USAGE Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Dilute prior to administration ( 2.1 , 5.1 ) Monitor serum potassium and adjust dosage accordingly ( 2.2 , 2.3 ) Treatment of hypokalemia: Adults: Initial doses range from 40-100 mEq/day in 2-5 divided doses: limit doses to 40 mEq per dose. Total daily dose should not exceed 200 mEq (2.2) Pediatric patients aged birth to 16 years old: 2-4 mEq/kg/day in divided doses; not to exceed 1 mEq/kg as a single dose or 40 mEq whichever is lower; if deficits are severe or ongoing losses are great, consider intravenous therapy.

Total daily dose should not exceed 100 mEq (2.3) Maintenance or Prophylaxis of hypokalemia: Adults: Typical dose is 20 mEq per day (2.2) Pediatric patients aged birth to 16 years old: typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day (2.3)

2.1Administration and Monitoring Monitoring Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor potassium levels daily or more often depending on the severity of hypokalemia until they return to normal. Monitor potassium levels monthly to biannually for maintenance or prophylaxis.

The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms and the clinical status of the patient. Correct volume status, acid-base balance and electrolyte deficits as appropriate. Administration Dilute the potassium chloride solution with at least 4 ounces of cold water [see Warnings and Precautions (5.1) ] .

Take with meals or immediately after eating. If serum potassium concentration is ˂2.5 mEq/L, use intravenous potassium instead of oral supplementation.

2.2Adult Dosing Treatment of hypokalemia Daily dose range from 40 to 100 mEq. Give in 2 to 5 divided doses; limit doses to 40 mEq per dose. The total daily dose should not exceed 200 mEq in a 24 hour period.

Maintenance or Prophylaxis Typical dose is 20 mEq per day. Individualize dose based upon serum potassium levels. Studies support the use of potassium replacement in digitalis toxicity.

When alkalosis is present, normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of potassium replacement in the setting of hyperkalemia is uncertain.

2.3Pediatric Dosing Treatment of hypokalemia Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy. Maintenance or Prophylaxis Pediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day.

Do not exceed 3 mEq/kg/day.

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Solution 10%: 1.3 mEq potassium per mL. Oral Solution 20%: 2.6 mEq potassium per mL. • Oral Solution: 10%; 1.3 mEq potassium per mL • Oral Solution: 20%; 2.6 mEq potassium per mL

⛔ Contraindications 21 words ▾

4 CONTRAINDICATIONS Potassium chloride is contraindicated in patients on potassium sparing diuretics. Concomitant use with potassium sparing diuretics. ( 4 )

⚠️ Warnings and Cautions 46 words ▾

5 WARNINGS AND PRECAUTIONS Gastrointestinal Irritation : Dilute before use, take with meals ( 5.1 )

5.1Gastrointestinal Irritation May cause gastrointestinal irritation if administered undiluted. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [see Dosage and Administration (2.1) ] .

🤒 Adverse Reactions 52 words ▾

6 ADVERSE REACTIONS The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 114 words ▾

7 DRUG INTERACTIONS Potassium sparing diuretics: Avoid concomitant use ( 7.1 ) Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia ( 7.2 ) Nonsteroidal Anti-Inflammatory drugs: Monitor for hyperkalemia ( 7.3 )

7.1Potassium-Sparing Diuretics Use with potassium-sparing diuretics can produce severe hyperkalemia. Avoid concomitant use.

7.2Renin-Angiotensin-Aldosterone System Inhibitors Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy.

7.3Nonsteroidal Anti-inflammatory Drugs (NSAIDs) NSAIDS may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Cirrhosis: Initiate therapy at the low end of the dosing range ( 8.5 ) Renal Impairment: Initiate therapy at the low end of the dosing range ( 8.6 )

8.1Pregnancy There are no human data related to use of Potassium Chloride during pregnancy, and animal studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as Potassium Chloride becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.

8.4Pediatric Use The safety and effectiveness of Potassium Chloride have been demonstrated in children with diarrhea and malnutrition from birth to 16 years.

8.5Geriatric Use Clinical studies of Potassium Chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug 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. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6Cirrhotics Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently. [ see Clinical Pharmacology (12.3 )].

8.7Renal Impairment Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on ACE inhibitors, ARBs, or nonsteroidal anti-inflammatory drugs should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia. The serum potassium level should be monitored frequently.

Renal function should be assessed periodically.

🤰 Pregnancy 90 words ▾

8.1Pregnancy There are no human data related to use of Potassium Chloride during pregnancy, and animal studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, respectively.

🧒 Pediatric Use 24 words ▾

8.4Pediatric Use The safety and effectiveness of Potassium Chloride have been demonstrated in children with diarrhea and malnutrition from birth to 16 years.

🧓 Geriatric Use 140 words ▾

8.5Geriatric Use Clinical studies of Potassium Chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug 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. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 207 words ▾

10 OVERDOSAGE

10.1Symptoms The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly potentially fatal hyperkalemia can result. Hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval).

Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

10.2Treatment Treatment measures for hyperkalemia include the following: Monitor closely for arrhythmias and electrolyte changes. Eliminate foods and medications containing potassium and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others. Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.

Administer intravenously 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1000 mL. Correct acidosis, if present, with intravenous sodium bicarbonate. Use exchange resins, hemodialysis, or peritoneal dialysis.

In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.

🧬 Clinical Pharmacology 197 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The potassium ion (K+) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 to 160 mEq per liter.

The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent, and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine.

The usual dietary intake of potassium is 50 to 100 mEq per day.

12.3Pharmacokinetics Based on published literature, the rate of absorption and urinary excretion of potassium from KCl oral solution were higher during the first few hours after dosing relative to modified release KCl products. The bioavailability of potassium, as measured by the cumulative urinary excretion of K+ over a 24 hour post dose period, is similar for KCl solution and modified release products.

🧬 Mechanism of Action 131 words ▾

12.1Mechanism of Action The potassium ion (K+) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 to 160 mEq per liter.

The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent, and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine.

The usual dietary intake of potassium is 50 to 100 mEq per day.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride Oral Solution, USP 10% (20 mEq/15 mL) is an orange flavored, clear orange-colored solution available as follows: NDC 0121-0948-16: 16 fl oz (473 mL) Bottle. NDC 0121-4948-15: 15 mL unit dose cup. Case contains 30 unit-dose cups of 15 mL (NDC 0121-4948-94), packaged in 3 trays of 10 unit-dose cups each, 40 unit-dose cups of 15 mL (NDC 0121-4948-40), packaged in 4 trays of 10 unit-dose cups each, 50 unit-dose cups of 15 mL (NDC 0121-4948-50), packaged in 5 trays of 10 unit-dose cups each, 80 unit-dose cups of 15 mL (NDC 0121-4948-80), packaged in 8 trays of 10 unit-dose cups each and 100 unit-dose cups of 15 mL (NDC 0121-4948-00), packaged in 10 trays of 10 unit-dose cups each.

NDC 0121-1896-30: 30 mL unit dose cup. Case contains 40 unit-dose cups of 30 mL (NDC 0121-1896-40), packaged in 4 trays of 10 unit-dose cups each, 50 unit-dose cups of 30 mL (NDC 0121-1896-50), packaged in 5 trays of 10 unit-dose cups each and 100 unit-dose cups of 30 mL (NDC 0121-1896-00), packaged in 10 trays of 10 unit-dose cups each. Potassium Chloride Oral Solution, USP 20% (40 mEq/15 mL) is an orange flavored, clear orange-colored, solution available as follows: NDC 0121-2847-16: 16 fl oz (473 mL) Bottle.

NDC 0121-2847-15: 15 mL unit dose cup. Case contains 30 unit-dose cups of 15 mL (NDC 0121-2847-94), packaged in 3 trays of 10 unit-dose cups each, 40 unit-dose cups of 15 mL (NDC 0121-2847-40), packaged in 4 trays of 10 unit-dose cups each, 50 unit-dose cups of 15 mL (NDC 0121-2847-50), packaged in 5 trays of 10 unit-dose cups each, 80 unit-dose cups of 15 mL (NDC 0121-2847-80), packaged in 8 trays of 10 unit-dose cups each and 100 unit-dose cups of 15 mL (NDC 0121-2847-00), packaged in 10 trays of 10 unit-dose cups each.

STORAGE Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. PROTECT from LIGHT and FREEZING.

📦 Storage and Handling 35 words ▾

STORAGE Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. PROTECT from LIGHT and FREEZING.

📋 Description 110 words ▾

11 DESCRIPTION Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55.

Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, orange flavor, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No.

6, glycerin, orange flavor, purified water, sodium benzoate, sodium citrate dihydrate and sucralose.

🍼 Nursing Mothers 60 words ▾

8.2Lactation Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as Potassium Chloride becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.

🧬 Pharmacokinetics 63 words ▾

12.3Pharmacokinetics Based on published literature, the rate of absorption and urinary excretion of potassium from KCl oral solution were higher during the first few hours after dosing relative to modified release KCl products. The bioavailability of potassium, as measured by the cumulative urinary excretion of K+ over a 24 hour post dose period, is similar for KCl solution and modified release products.

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

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL) NDC 0121-0948-16 Potassium Chloride Oral Solution, USP 10% 20 mEq / 15 mL DILUTE PRIOR TO ADMINISTRATION Rx ONLY 16 fl oz (473 mL) PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 X0948160422 R04/22 PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Cup Label Delivers 15 mL NDC 0121-4948-15 Potassium Chloride Oral Solution, USP 10% 20 mEq per 15 mL DILUTE PRIOR TO ADMINISTRATION Package Not Child-Resistant Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 PRINCIPAL DISPLAY PANEL - 15 mL Cup Label - 10%

PRINCIPAL DISPLAY PANEL - 30 mL Cup Label Delivers 30 mL NDC 0121-1896-30 Potassium Chloride Oral Solution, USP 10% 40 mEq per 30 mL DILUTE PRIOR TO ADMINISTRATION Package Not Child-Resistant Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 PRINCIPAL DISPLAY PANEL - 30 mL Cup Label

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL) NDC 0121-2847-16 Potassium Chloride Oral Solution, USP 20% 40 mEq / 15 mL DILUTE PRIOR TO ADMINISTRATION Rx ONLY 16 fl oz (473 mL) PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 X0948160422 R04/22 PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Cup Label Delivers 15 mL NDC 0121-2847-15 Potassium Chloride Oral Solution, USP 20% 40 mEq per 15 mL DILUTE PRIOR TO ADMINISTRATION Package Not Child-Resistant Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 PRINCIPAL DISPLAY PANEL - 15 mL Cup 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 – Q4 2025 · 4 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
9.6K
Units reimbursed last 4 qtrs
5.5M
Gross reimbursed last 4 qtrs
$383.9K
Avg / prescription
$39.98
Avg / unit
$0.0695
Latest quarter Q4 2025
2KRx
Medicaid pays / mL
$0.0695
gross reimbursed
vs
NADAC / mL
$0.0409
acquisition cost
=
Spread
+$0.0286
+70% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
53% FFS 47% MCO
Fee-for-service · 5,071 Rx Managed care · 4,531 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 244,335 units · 3,128 per 100k residents WA Idaho: 22,902 units · 1,166 per 100k residents ID Montana: 12,864 units · 1,136 per 100k residents MT North Dakota: no data reported ND Minnesota: 56,150 units · 979 per 100k residents MN Wisconsin: 98,472 units · 1,666 per 100k residents WI Michigan: 90,789 units · 905 per 100k residents MI New York: 366,634 units · 1,873 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 152,814 units · 3,610 per 100k residents OR Nevada: 38,979 units · 1,220 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 15,852 units · 494 per 100k residents IA Illinois: 291,370 units · 2,322 per 100k residents IL Indiana: 111,581 units · 1,626 per 100k residents IN Ohio: 386,512 units · 3,280 per 100k residents OH Pennsylvania: 170,643 units · 1,317 per 100k residents PA New Jersey: 264,474 units · 2,847 per 100k residents NJ Massachusetts: 79,980 units · 1,142 per 100k residents MA California: 1,187,494 units · 3,048 per 100k residents CA Utah: 11,927 units · 349 per 100k residents UT Colorado: no data reported CO Nebraska: 4,781 units · 242 per 100k residents NE Missouri: 58,937 units · 951 per 100k residents MO Kentucky: 97,643 units · 2,157 per 100k residents KY West Virginia: 19,610 units · 1,108 per 100k residents WV Virginia: 74,335 units · 853 per 100k residents VA Maryland: 57,336 units · 928 per 100k residents MD Connecticut: 93,042 units · 2,572 per 100k residents CT Rhode Island: 34,263 units · 3,129 per 100k residents RI Arizona: 128,672 units · 1,732 per 100k residents AZ New Mexico: no data reported NM Kansas: 17,095 units · 581 per 100k residents KS Arkansas: 26,685 units · 870 per 100k residents AR Tennessee: 85,508 units · 1,200 per 100k residents TN North Carolina: 111,526 units · 1,029 per 100k residents NC South Carolina: 137,045 units · 2,551 per 100k residents SC Delaware: 37,892 units · 3,675 per 100k residents DE Oklahoma: 47,728 units · 1,178 per 100k residents OK Louisiana: 81,300 units · 1,777 per 100k residents LA Mississippi: 32,369 units · 1,101 per 100k residents MS Alabama: 104,807 units · 2,052 per 100k residents AL Georgia: 75,027 units · 680 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 120,353 units · 395 per 100k residents TX Florida: 477,682 units · 2,113 per 100k residents FL
Units reimbursed · per 100k residents
2423,675
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 Delaware 3,675 /100k
2 Oregon 3,610 /100k
3 Ohio 3,280 /100k
4 Rhode Island 3,129 /100k
5 Washington 3,128 /100k
6 California 3,048 /100k
7 New Jersey 2,847 /100k
8 Connecticut 2,572 /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.

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

Medicare Part D (outpatient prescription) spending for Potassium Chloride — the program that covers self-administered drugs. 42 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Potassium Chloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$78.71M
Claims incl. refills
3.7M
Beneficiaries
2.4M
Spend / beneficiary
$33.46
Spend / claim
$21.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 00121-0945-00 · PAI 00121-0950-03 · PAI →
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.