HomeNDC LookupIngredientsPotassium Chloride › 69238-1459-02
Potassium Chloride 1.5 g/15mL Solution, 473 mL — NDC 69238-1459-02 package photo

Potassium Chloride 1.5 g/15mL Solution, 473 mL

by Amneal Pharmaceuticals NY LLC · 473 mL in 1 BOTTLE (69238-1459-2)
NDC 69238-1459-02
🏷️ FDA NDC (as labeled) 69238-1459-2 billing pads the package segment with a zero
This package
Contains473 mL Cost per mL$0.0395 NADAC Per package$18.68 / 473 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0598/unit · Part D plans $0.0928/unit — full pricing hub ↓
Also comes in: 10 cups 69238-1459-04
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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

FDA NDC (as labeled) 69238-1459-2
Product NDC 69238-1459
11-digit billing NDC 69238145902
NCPDP billing unit ML — per mL (volume)
RxCUI 312515, 314182
UNII 660YQ98I10
Application # ANDA210041
SPL Set ID 590dd25c-c4cb-489a-a09b-eccbf1d37c1f
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 2018-07-24
Route ORAL
Dosage form SOLUTION
Substance POTASSIUM CHLORIDE
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
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 69238-1459-2 — a 5-4-1 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 package segment → 69238-1459-02. 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.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals NY LLC
Application holderAMNEAL PHARMACEUTICALS LLC
FDA applicationANDA210041 (ANDA)
Labeler code69238
First marketedJul 2018
Product typeHuman Prescription Drug
Portfolio372 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.

🩺 Clinical

Label name POTASSIUM CL 10% (20 MEQ/15ML) Ingredient Potassium Chloride
📖 What it is MedlinePlus · NLM

Potassium is essential for the proper functioning of the heart, kidneys, muscles, nerves, and digestive system. Usually the food you eat supplies all of the potassium you need. However, certain diseases (e.g., kidney disease and gastrointestinal disease with vomiting and diarrhea) and drugs, especially diuretics ('water pills'), remove potassium from the body. Potassium supplements are taken to replace potassium losses and prevent potassium deficiency. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You're right that food is the first line — bananas, potatoes, and leafy greens are all rich in potassium. But sometimes diet alone isn't enough, especially if you're taking a diure...
  • Why did my doctor prescribe potassium chloride? I thought potassium just came from bananas.
  • Yes — always take oral tablets or capsules with a meal or right after eating. Taking them on an empty stomach can irritate or even ulcerate the lining of your stomach or intestines...
  • Do I have to take it with food? What happens if I forget?
📖 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.

💊 What it looks like

Color 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 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.

9 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 DailyMedingredient 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.

💲 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 $0.040 $18.68 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0598 $28.29 / 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 2021 Jul 2022 Dec 2025 Aug 2026 $0.154 $0.038
▼ Down 74% over the last 24 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Chloride 20 meq/15mL 00121-0948-16 PAI 473 ml $0.039 AA Availability likely
Potassium Chloride 20 meq/15mL 00603-1542-58 Endo 473 ml $0.039 AA Availability likely
Potassium Chloride 20 meq/15mL 59651-0959-47 Aurobindo 473 ml $0.039 AA Availability likely
Potassium Chloride 1.5 g/15mLthis 69238-1459-02 Amneal 473 ml $0.039 AA Availability likely
Potassium Chloride 20 meq/15mL 70010-0072-44 Granules 473 ml $0.039 AA Availability likely
Potassium Chloride 20 meq/15mL 72888-0041-13 Advagen 473 ml $0.039 AA Availability likely
Potassium Chloride 20 meq/15mL 43386-0168-01 Lupin 473 ml $0.084 AA FDA listed +112%
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 FDA listed
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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

🗺️ 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 69238-1459-02, 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
10.7K
Units reimbursed last 4 qtrs
6.1M
Gross reimbursed last 4 qtrs
$364.9K
Avg / prescription
$34.05
Avg / unit
$0.0598
Latest quarter Q4 2025
2.5KRx
Medicaid pays / mL
$0.0598
gross reimbursed
vs
NADAC / mL
$0.0395
acquisition cost
=
Spread
+$0.0203
+51% 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
59% FFS 41% MCO
Fee-for-service · 6,376 Rx Managed care · 4,341 Rx
State Medicaid map
Alaska: no data reported AK Maine: 90,712 units · 6,503 per 100k residents ME Washington: 82,037 units · 1,050 per 100k residents WA Idaho: 50,023 units · 2,547 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 105,762 units · 1,844 per 100k residents MN Wisconsin: 146,805 units · 2,484 per 100k residents WI Michigan: 201,351 units · 2,006 per 100k residents MI New York: 361,749 units · 1,848 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 81,624 units · 1,928 per 100k residents OR Nevada: 6,918 units · 217 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 32,517 units · 1,014 per 100k residents IA Illinois: 496,502 units · 3,957 per 100k residents IL Indiana: 143,406 units · 2,090 per 100k residents IN Ohio: 326,274 units · 2,769 per 100k residents OH Pennsylvania: 265,584 units · 2,049 per 100k residents PA New Jersey: 120,631 units · 1,299 per 100k residents NJ Massachusetts: 38,475 units · 550 per 100k residents MA California: 1,261,302 units · 3,237 per 100k residents CA Utah: no data reported UT Colorado: 138,466 units · 2,356 per 100k residents CO Nebraska: 91,024 units · 4,602 per 100k residents NE Missouri: 154,144 units · 2,488 per 100k residents MO Kentucky: 164,484 units · 3,634 per 100k residents KY West Virginia: 71,203 units · 4,023 per 100k residents WV Virginia: 79,743 units · 915 per 100k residents VA Maryland: 148,605 units · 2,405 per 100k residents MD Connecticut: 72,966 units · 2,017 per 100k residents CT Rhode Island: no data reported RI Arizona: 56,146 units · 756 per 100k residents AZ New Mexico: 45,077 units · 2,132 per 100k residents NM Kansas: 52,252 units · 1,777 per 100k residents KS Arkansas: 17,019 units · 555 per 100k residents AR Tennessee: 146,309 units · 2,053 per 100k residents TN North Carolina: 119,657 units · 1,104 per 100k residents NC South Carolina: 26,257 units · 489 per 100k residents SC Delaware: 44,862 units · 4,351 per 100k residents DE Oklahoma: 43,329 units · 1,069 per 100k residents OK Louisiana: 88,992 units · 1,946 per 100k residents LA Mississippi: 69,162 units · 2,352 per 100k residents MS Alabama: 115,194 units · 2,255 per 100k residents AL Georgia: 147,893 units · 1,341 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 182,250 units · 597 per 100k residents TX Florida: 217,617 units · 962 per 100k residents FL
Units reimbursed · per 100k residents
2176,503
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 Maine 6,503 /100k
2 Nebraska 4,602 /100k
3 Delaware 4,351 /100k
4 West Virginia 4,023 /100k
5 Illinois 3,957 /100k
6 Kentucky 3,634 /100k
7 California 3,237 /100k
8 Ohio 2,769 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
473 ml this page69238-1459-02 10,717 Rx · $364,918
10 cups69238-1459-04 No Medicaid data
Drug total (last 4 qtrs): 10,717 Rx · 6,104,320 units · $364,918 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Potassium Chloride — the ingredient across all brands.

Top reported reactions

Nausea9,006
Diarrhoea8,604
Dyspnoea8,414
Fatigue8,118
Vomiting6,603
Death5,805
Pneumonia5,556

Reporter sex

120,818 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Death16,417
Life-threatening6,633
Disabling2,798
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,102 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
69238-1459-02 You're viewing this 473 mL in 1 BOTTLE (69238-1459-2) $0.0395 / mL $18.67 2018-07-24 Active
69238-1459-04 10 CUP, UNIT-DOSE in 1 TRAY (69238-1459-4) / 15 mL in 1 CUP, UNIT-DOSE (69238-1459-3) 2018-07-24 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 69238-1459-02?
NDC 69238-1459-02 contains 473 mL — 473 ml in 1 bottle.
What NDC number is used to bill for this package of Potassium Chloride 1.5 g/15mL Solution?
Bill NDC 69238-1459-02 — the 11-digit billing format is 69238145902. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 73 words

1 INDICATIONS AND USAGE Potassium chloride oral solution 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 oral solution 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. ( 1 )

⏱️ 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 mEq to 100 mEq/day orally in 2 to 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 mEq to 4 mEq/kg/day orally 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 orally per day (2.2) Pediatric patients aged birth to 16 years old: typical dose is 1 mEq/kg/day orally. 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) ] .

Instruct patients or caregivers to use an oral dosing cup or syringe to correctly measure the prescribed amount of medication. Inform patients that oral dosing cups or syringes may be obtained from their pharmacy. 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 mEq to 100 mEq orally. 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 orally. 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 mEq/kg/day to 4 mEq/kg/day orally in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq orally, whichever is lower; maximum daily doses should not exceed 100 mEq orally. 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 orally.

Do not exceed 3 mEq/kg/day.

💊 Dosage Forms and Strengths 43 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 ( 3 ) Oral Solution: 20%; 2.6 mEq potassium per mL ( 3 )

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 45 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 53 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 Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 115 words

7 DRUG INTERACTIONS Potassium Sparing Diuretics: Avoid concomitant use ( 7.1 ) Renin-Angiotensin-Aldosterone System 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 (8.6) Renal Impairment: Initiate therapy at the low end of the dosing range (8.7)

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 defects, 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 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.

8.6Cirrhosis 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 94 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 defects, 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 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 213 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 mEq/L to 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 mEq/L to 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 203 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 mEq to 160 mEq per liter.

The normal adult plasma concentration is 3.5 mEq 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 mEq 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 136 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 mEq to 160 mEq per liter.

The normal adult plasma concentration is 3.5 mEq 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 mEq to 100 mEq per day.

📦 How Supplied / Storage and Handling 136 words

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium chloride oral solution USP, 10% (20 mEq per 15 mL) is supplied as a clear, orange colored solution available as follows: Bottle of 473 mL NDC 69238-1459-2 10 x 15 mL unit dose cups in a tray NDC 69238-1459-4 Potassium chloride oral solution USP, 20% (40 mEq per 15 mL) is supplied as a clear, orange colored solution available as follows: Bottle of 473 mL NDC 69238-1458-2 10 x 15 mL unit dose cups in a tray NDC 69238-1458-4 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 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. Rx only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.

07-2026-04

📋 Description 110 words

11 DESCRIPTION Potassium chloride, USP is a white granular powder. It is freely soluble in water and insoluble in alcohol. Chemically, potassium chloride, USP 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 #6, glycerin, methylparaben, natural/artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural/artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

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