HomeNDC LookupIngredientsPotassium Chloride › 68382-0740-05
Potassium Chloride 1500 mg Tablet, Extended Release, 500-count — NDC 68382-0740-05 package photo

Potassium Chloride 1500 mg Tablet, Extended Release, 500-count

by Zydus Pharmaceuticals (USA) Inc. · 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-740-05)
NDC 68382-0740-05
🏷️ FDA NDC (as labeled) 68382-740-05 billing pads the product segment with a zero
This package
Contains500-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2295/unit — full pricing hub ↓
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) 68382-740-05
Product NDC 68382-740
11-digit billing NDC 68382074005
RxCUI 1801294, 1801298
UNII 660YQ98I10
UPC 0368382861016, 0368382740014
Application # ANDA210395
SPL Set ID 31e02249-7984-4b8f-9e37-2b79b708ac08
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-03
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance POTASSIUM CHLORIDE
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 68382-740-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68382-0740-05. 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

LabelerZydus Pharmaceuticals (USA) Inc.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA210395 (ANDA)
Labeler code68382
First marketedFeb 2022
Product typeHuman Prescription Drug
Portfolio173 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

📖 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 White
ShapeCapsule
ImprintKCl20
Size22 mm
ScoringScored — splits in 2
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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 47MLB0F1MV
    Ethylcellulose is a plant-based thickening agent made from cellulose. It slows how fast the medicine dissolves, helping control drug release in the stomach and intestines.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

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 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 eachPer 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 $0.2295 $114.75 / 500 tablets
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 1500 mg 00832-5325-10 Upsher-SmithLaboratories, 1000 tablets $0.135 AB1 Availability likely
Potassium Chloride 1500 mg 00904-7293-61 Major 1 tablet $0.135 Availability likely
Potassium Chloride 20 meq 00904-7548-61 Major 1 tablet $0.135 AB1 Availability likely
Potassium Chloride 1500 mg 31722-0135-01 Camber 100 tablets $0.135 AB1 Availability likely
Potassium Chloride 20 meq 60687-0756-09 American 1 tablet $0.135 AB1 Availability likely
Potassium Chloride 20 meq 62037-0720-01 Actavis 100 tablets $0.135 AB1 Availability likely
Potassium Chloride 20 meq 63304-0987-01 Sun 100 tablets $0.135 AB1 Availability likely
Potassium Chloride Extended-release 1500 mg 68001-0567-00 Bluepoint 100 tablets $0.135 AB1 Availability likely
potassium chloride 1500 mg 68462-0472-01 Glenmark 100 tablets $0.135 AB1 Discontinued
Potassium Chloride Extended-release 1500 mg 70010-0135-01 Granules 100 tablets $0.135 AB1 Availability likely
potassium chloride 1500 mg 72603-0338-01 Northstar 100 tablets $0.135 AB1 Availability likely
Klor-Con M 1500 mg 00245-5319-01 Upsher-Smith 1 tablet $0.148 AB1 Availability likely
Potassium Chloride 1500 mg 70436-0153-01 Slate 100 tablets $0.169 AB3 Availability likely
Potassium Chloride Extended-Release 1500 mg 24979-0232-01 Upsher-Smith 100 tablets $0.169 AB3 Availability likely
Potassium chloride 1500 mg 72888-0076-01 Advagen 100 tablets $0.169 Availability likely
Potassium Chloride Extended-Release 1500 mg 00615-8400-05 NCS 15 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 17856-1135-01 Atlantic 1 tablet AB1 FDA listed
Potassium Chloride 1500 mg 42291-0507-01 AvKARE 100 tablets AB1 FDA listed
Potassium Chloride 20 meq 43386-0917-01 Lupin 100 tablets AB1 FDA listed
Potassium Chloride 1500 mg 43547-0550-10 Solco 100 tablets AB1 FDA listed
potassium chloride 1500 mg 50090-3700-00 A-S 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 50090-5665-00 A-S 30 tablets FDA listed
Potassium Chloride 1500 mg 50090-6253-00 A-S 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 50090-6866-00 A-S 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 50090-6867-00 A-S 90 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 50090-7192-00 A-S 30 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 50090-7193-00 A-S 90 tablets AB1 FDA listed
potassium chloride 1500 mg 50090-7456-00 A-S 90 tablets AB1 FDA listed
Potassium Chloride 1500 mg 50090-7616-00 A-S 90 tablets AB1 FDA listed
Potassium Chloride 1500 mg 51655-0568-25 Northwind 60 tablets AB1 FDA listed
Klor-Con M 1500 mg 55154-5634-00 Cardinal 1 tablet AB1 FDA listed
Potassium Chloride 1500 mg 59651-0431-01 Aurobindo 100 tablets FDA listed
Potassium Chloride Extended-release 1500 mg 62207-0727-08 Granules 800 tablets AB1 FDA listed
potassium chloride 1500 mg 67296-2131-02 Redpharm 20 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 67296-2160-01 Redpharm 10 tablets AB1 FDA listed
Potassium Chloride 1500 mg 67296-2243-06 Redpharm 30 tablets AB1 FDA listed
Potassium Chloride 1500 mgthis 68382-0740-05 Zydus 500 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 68788-8196-03 Preferred 30 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 70518-4383-00 REMEDYREPACK 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 70771-1600-00 Zydus 1000 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 71205-0824-03 Proficient 3 tablets AB1 FDA listed
potassium chloride 1500 mg 71335-1109-01 Bryant 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 71335-1747-01 Bryant 30 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 71335-1896-01 Bryant 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 71335-2045-01 Bryant 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 71610-0343-15 Aphena 15 tablets AB1 FDA listed
Potassium Chloride 1500 mg 71610-0632-15 Aphena 15 tablets AB1 FDA listed
Potassium Chloride ER 1500 mg 72189-0462-30 Direct_Rx 30 tablets AB1 FDA listed
Potassium Chloride ER 1500 mg 72189-0629-30 Direct_Rx 30 tablets AB1 FDA listed
Potassium Chloride 20 meq 72789-0365-01 PD-Rx 100 tablets AB1 FDA listed
Potassium Chloride 1500 mg 72865-0196-01 XLCare 100 tablets AB1 FDA listed
Potassium Chloride 1500 mg 72888-0099-00 Advagen 1000 tablets AB1 FDA listed
Potassium Chloride 20 meq 82804-0075-03 Proficient 3 tablets AB1 FDA listed
Potassium chloride 1500 mg 72789-0504-82 PD-Rx 500 tablets FDA listed
Potassium Chloride Extended-Release 1500 mg 82804-0057-30 Proficient 30 tablets AB3 FDA listed
Potassium Chloride 1500 mg 00615-8580-05 NCS 15 tablets AB3 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

🏛️
2022
On the market since
Feb 2022
📍
2026
Currently FDA-listed
4 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.

📊 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 Marketing startStatus
68382-0740-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-740-01) 2022-02-03 Active
68382-0740-05 You're viewing this 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-740-05) 2022-02-03 Active
68382-0740-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-740-10) 2022-02-03 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 68382-0740-05?
NDC 68382-0740-05 is a 500-count package — 500 tablet, extended release in 1 bottle.
What is the difference between NDC 68382-0740-05 and NDC 68382-0740-01?
Both are Potassium Chloride 1500 mg Tablet, Extended Release — the drug itself is identical. NDC 68382-0740-05 is the 500-count package, while NDC 68382-0740-01 is the 100 tablets package.
What NDC number is used to bill for this package of Potassium Chloride 1500 mg Tablet, Extended Release?
Bill NDC 68382-0740-05 — the 11-digit billing format is 68382074005. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68382-740-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68382-0740-05, written without dashes as 68382074005. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68382-0740-05, the first segment (68382) is the labeler code FDA assigned to Zydus Pharmaceuticals (USA) Inc.; the middle segment (0740) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Zydus Pharmaceuticals (USA) Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 100 tablets (68382-0740-01), 1000 tablets (68382-0740-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Pharmaceuticals (USA) Inc. 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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 209 words

INDICATIONS AND USAGE BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis.

If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used.

Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION The usual dietary intake of potassium by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store. Dosage must be adjusted to the individual needs of each patient.

The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.

Each Potassium chloride extended-release tablet, USP 20 mEq provides 1500 mg of potassium chloride equivalent to 20 mEq of potassium. Each Potassium chloride extended-release tablet, USP 10 mEq provides 750 mg of potassium chloride equivalent to 10 mEq of potassium. Potassium chloride extended-release tablets should be taken with meals and with a glass of water or other liquid.

This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS ). Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration: Break the tablet in half, and take each half separately with a glass of water. Prepare an aqueous (water) suspension as follows: Place the whole tablet(s) in approximately one-half glass of water (4 fluid ounces).

Allow approximately 2 minutes for the tablet(s) to disintegrate. Stir for about half a minute after the tablet(s) has disintegrated. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.

Add another one fluid ounce of water, swirl, and consume immediately. Then, add an additional one fluid ounce of water, swirl, and consume immediately. Aqueous suspension of potassium chloride extended-release tablet that is not taken immediately should be discarded.

The use of other liquids for suspending potassium chloride extended-release tablet is not recommended.

Contraindications 174 words

CONTRAINDICATIONS Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis, such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (e.g., spironolactone, triamterene, amiloride) (see OVERDOSAGE ).

Controlled-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of potassium chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections). All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (e.g., diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

⚠️ Warnings ~2 min read

WARNINGS Hyperkalemia (see OVERDOSAGE) In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic.

The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment. Interaction with Potassium-Sparing Diuretics Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene, or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Angiotensin-Converting Enzyme Inhibitors Angiotensin-converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring. Gastrointestinal Lesions Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract.

Based on spontaneous adverse reaction reports, enteric-coated preparations of potassium chloride are associated with an increased frequency of small bowel lesions (40-50 per 100,000 patient years) compared to sustained release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. Potassium chloride is a tablet formulated to provide a controlled rate of release of microencapsulated potassium chloride and thus to minimize the possibility of a high local concentration of potassium near the gastrointestinal wall.

Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after 1 week of solid oral potassium chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms.

In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under conditions which did not resemble usual or recommended clinical practice (i.e., 96 mEq per day in divided doses of potassium chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (Hemoccult testing).

The relevance of these findings to the usual conditions (i.e., non-fasting, no anticholinergic agent, smaller doses) under which controlled-release potassium chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. Potassium chloride extended-release tablets should be discontinued immediately and the possibility of ulceration, obstruction, or perforation should be considered if severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs.

Metabolic Acidosis Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

🤒 Adverse Reactions 90 words

ADVERSE REACTIONS One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS , WARNINGS , and OVERDOSAGE ). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS ). The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.

These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the amount taken at one time.

🔄 Drug Interactions 10 words

Drug Interactions Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS ).

🧒 Pediatric Use 12 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 139 words

Geriatric 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 ~1 min read

OVERDOSAGE 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 intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS ). It is important to recognize that 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). Treatment measures for hyperkalemia include the following: Patients should be closely monitored for arrythmias and electrolyte changes. Elimination of 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.

Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL. Correction of acidosis, if present, with intravenous sodium bicarbonate.

Use of exchange resins, hemodialysis, or peritoneal dialysis. In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. The extended-release feature means that absorption and toxic effects may be delayed for hours.

Consider standard measures to remove any unabsorbed drug.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY The potassium ion 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. Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition.

Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances or cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.

If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long-term diuretic therapy, supplemental potassium in the form of high-potassium food or potassium chloride may be able to restore normal potassium levels. In rare circumstances (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

📦 How Supplied / Storage and Handling 145 words

HOW SUPPLIED Potassium Chloride Extended-release Tablets, USP 10 mEq are white to off-white colored, capsule shaped, biconvex uncoated tablets debossed with "KCl 10" on one side and plain on the other side and are supplied as follows: NDC 68382-861-01 in bottle of 100 tablets NDC 68382-861-10 in bottle of 1000 tablets Potassium Chloride Extended-release Tablets, USP 20 mEq are white to off-white colored, capsule shaped, biconvex uncoated tablets debossed with "KCl" and "20" on either side of break line and plain on the other side and are supplied as follows: NDC 68382-740-01 in bottle of 100 tablets NDC 68382-740-05 in bottle of 500 tablets NDC 68382-740-10 in bottle of 1000 tablets Keep tightly closed.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

📋 Description ~1 min read

DESCRIPTION The Potassium Chloride Extended-release Tablets, USP 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-release Tablets, USP 10 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet.

These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl.

Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus.

It is freely soluble in water and insoluble in alcohol. Potassium chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrate within one minute.

The microencapsulated crystals are formulated to provide an extended release of potassium chloride. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hyrpromellose, microcrystalline cellulose, polyethylene glycol and povidone. USP Assay preparation is pending.

💬 Information for Patients ~1 min read

Information for Patients Physicians should consider reminding the patient of the following: To take each dose with meals and with a full glass of water or other liquid. To take each dose without crushing, chewing, or sucking the tablets. If those patients are having difficulty swallowing whole tablets, they may try one of the following alternate methods of administration: Break the tablet in half, and take each half separately with a glass of water.

Prepare an aqueous (water) suspension as follows: Place the whole tablet(s) in approximately one-half glass of water (4 fluid ounces). Allow approximately 2 minutes for the tablet(s) to disintegrate. Stir for about half a minute after the tablet(s) has disintegrated.

Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw. Add another one fluid ounce of water, swirl, and consume immediately. Then, add an additional one fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of potassium chloride extended-release tablet that is not taken immediately should be discarded. The use of other liquids for suspending potassium chloride extended-release tablet is not recommended. To take this medicine following the frequency and amount prescribed by the physician.

This is especially important if the patient is also taking diuretics and/or digitalis preparations. To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

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.