Potassium Chloride Extended-release 1500 mg Tablet, 500-count — NDC 68001-0567-03 package photo

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

by Bluepoint Laboratories · 500 TABLET in 1 BOTTLE (68001-567-03)
NDC 68001-0567-03
🏷️ FDA NDC (as labeled) 68001-567-03 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.1351 NADAC Per package$67.55 / 500 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3417/unit · Part D plans $0.2295/unit — full pricing hub ↓
Also comes in: 100 tablets 68001-0567-00
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 →

🆔 Identity & classification

FDA NDC (as labeled) 68001-567-03
Product NDC 68001-567
11-digit billing NDC 68001056703
NCPDP billing unit EA — each (per item)
RxCUI 1801294, 1801298
UNII 660YQ98I10
Application # ANDA214452
SPL Set ID d605ca36-2bfa-42cb-a46c-8ecb3162994e
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 2021-01-30
Route ORAL
Dosage form TABLET
Substance POTASSIUM CHLORIDE
GPI-14 79700030100440
GCN Seq No 022346
GCN 03513
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 ER 20 MEQ TABLET
FDB brand name Potassium Chloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 68001-567-03 — 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 → 68001-0567-03. 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

LabelerBluepoint Laboratories
Application holderGRANULES INDIA LTD
FDA applicationANDA214452 (ANDA)
Labeler code68001
First marketedJan 2021
Product typeHuman Prescription Drug
Portfolio347 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 ER 20 MEQ TABLET Ingredient Potassium Chloride
📗 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
ShapeOval
ImprintG20M
Size21 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 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 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

5 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 eaPer package
Retail pharmacies payNADAC · weekly $0.135 $67.55 / 500 tablets
Medicaid paysCMS SDUD · 12 mo $0.3417 $170.85 / 500 tablets
Medicare drug plans payPart D · Q2 2026 $0.2295 $114.75 / 500 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.167 $0.133
▼ Down 19% over the last 12 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 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 mgthis 68001-0567-03 Bluepoint 500 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 +10%
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 mg 68382-0740-01 Zydus 100 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
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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

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

🗺️ 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 68001-0567-03, 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
48.7K
Units reimbursed last 4 qtrs
2.1M
Gross reimbursed last 4 qtrs
$706.5K
Avg / prescription
$14.50
Avg / unit
$0.3417
Latest quarter Q4 2025
12.5KRx
Medicaid pays / ea
$0.3417
gross reimbursed
vs
NADAC / ea
$0.1351
acquisition cost
=
Spread
+$0.2066
+153% vs cost
What Medicaid paid per ea (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
45% FFS 55% MCO
Fee-for-service · 21,949 Rx Managed care · 26,774 Rx
State Medicaid map
Alaska: no data reported AK Maine: 17,385 units · 1,246 per 100k residents ME Washington: 47,997 units · 614 per 100k residents WA Idaho: 24,991 units · 1,272 per 100k residents ID Montana: 5,809 units · 513 per 100k residents MT North Dakota: 10,639 units · 1,359 per 100k residents ND Minnesota: 51,175 units · 892 per 100k residents MN Wisconsin: 78,833 units · 1,334 per 100k residents WI Michigan: 99,800 units · 994 per 100k residents MI New York: 37,811 units · 193 per 100k residents NY Vermont: no data reported VT New Hampshire: 656 units · 46.8 per 100k residents NH Oregon: 29,937 units · 707 per 100k residents OR Nevada: 5,044 units · 158 per 100k residents NV Wyoming: 517 units · 88.5 per 100k residents WY South Dakota: 2,058 units · 224 per 100k residents SD Iowa: 23,789 units · 742 per 100k residents IA Illinois: 92,692 units · 739 per 100k residents IL Indiana: 42,716 units · 623 per 100k residents IN Ohio: 91,085 units · 773 per 100k residents OH Pennsylvania: 71,660 units · 553 per 100k residents PA New Jersey: 17,139 units · 184 per 100k residents NJ Massachusetts: 21,345 units · 305 per 100k residents MA California: 118,447 units · 304 per 100k residents CA Utah: 13,939 units · 408 per 100k residents UT Colorado: 15,521 units · 264 per 100k residents CO Nebraska: 9,359 units · 473 per 100k residents NE Missouri: 120,741 units · 1,949 per 100k residents MO Kentucky: 249,584 units · 5,514 per 100k residents KY West Virginia: 65,939 units · 3,725 per 100k residents WV Virginia: 58,693 units · 673 per 100k residents VA Maryland: 9,021 units · 146 per 100k residents MD Connecticut: 10,935 units · 302 per 100k residents CT Rhode Island: 5,809 units · 531 per 100k residents RI Arizona: 9,025 units · 121 per 100k residents AZ New Mexico: 26,752 units · 1,265 per 100k residents NM Kansas: 33,762 units · 1,148 per 100k residents KS Arkansas: 77,547 units · 2,528 per 100k residents AR Tennessee: 30,357 units · 426 per 100k residents TN North Carolina: 74,075 units · 684 per 100k residents NC South Carolina: 19,396 units · 361 per 100k residents SC Delaware: 4,126 units · 400 per 100k residents DE Oklahoma: 24,927 units · 615 per 100k residents OK Louisiana: 44,087 units · 964 per 100k residents LA Mississippi: 24,887 units · 846 per 100k residents MS Alabama: 57,194 units · 1,120 per 100k residents AL Georgia: 102,587 units · 930 per 100k residents GA D.C.: 442 units · 65.1 per 100k residents DC Hawaii: no data reported HI Texas: 60,970 units · 200 per 100k residents TX Florida: 26,397 units · 117 per 100k residents FL
Units reimbursed · per 100k residents
46.85,514
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 Kentucky 5,514 /100k
2 West Virginia 3,725 /100k
3 Arkansas 2,528 /100k
4 Missouri 1,949 /100k
5 North Dakota 1,359 /100k
6 Wisconsin 1,334 /100k
7 Idaho 1,272 /100k
8 New Mexico 1,265 /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.
500 tablets this page68001-0567-03 48,723 Rx · $706,534
100 tablets68001-0567-00 11,809 Rx · $163,103
Drug total (last 4 qtrs): 60,532 Rx · 2,591,060 units · $869,637 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Extended-release — the ingredient across all brands.

Top reported reactions

Diarrhoea6,759
Dyspnoea6,670
Nausea6,490
Fatigue6,279
Death4,580
Pneumonia4,490
Headache4,144

Reporter sex

92,143 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Death13,519
Life-threatening5,726
Disabling2,142
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,495 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
68001-0567-00 100 TABLET in 1 BOTTLE (68001-567-00) $0.1351 / ea $13.51 2023-04-17 Active
68001-0567-03 You're viewing this 500 TABLET in 1 BOTTLE (68001-567-03) $0.1351 / ea $67.53 2023-04-17 Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1351 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 80% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 68001-0567-03?
NDC 68001-0567-03 is a 500-count package — 500 tablet in 1 bottle.
What is the difference between NDC 68001-0567-03 and NDC 68001-0567-00?
Both are Potassium Chloride Extended-release 1500 mg Tablet — the drug itself is identical. NDC 68001-0567-03 is the 500-count package, while NDC 68001-0567-00 is the 100 tablets package.
What NDC number is used to bill for this package of Potassium Chloride Extended-release 1500 mg Tablet?
Bill NDC 68001-0567-03 — the 11-digit billing format is 68001056703. 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 211 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. 1. 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. 2. 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 to 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 tablets 10 mEq provides 750 mg of potassium chloride equivalent to 10 mEq of potassium chloride. Each potassium chloride extended release tablets 20 mEq provides 1500 mg of potassium chloride equivalent to 20 mEq of potassium chloride. 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: a. Break the tablet in half and take each half separately with a glass of water. b.

Prepare an aqueous (water) suspension as follows: 1. Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces). 2.

Allow approximately 2 minutes for the tablet(s) to disintegrate. 3. Stir for about half a minute after the tablet(s) has disintegrated.

4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw. 5.

Add another one fluid ounce of water, swirl, and consume immediately. 6. Then, add an additional one fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of potassium chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassium chloride extended release tablets 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, or 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 ]. 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 Renin 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. Interaction with Nonsteroidal Anti-Inflammatory Drugs Nonsteroidal anti-inflammatory drugs (NSAIDs) may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system.

Closely monitor potassium in patients receiving concomitant NSAID therapy 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 to 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 extended release tablets is a tablet formulated to provide an 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 extended-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…

🤒 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.

🆘 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 to 8 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 to 12 mEq/L). Treatment measures for hyperkalemia include the following: 1. Patients should be closely monitored for arrhythmias and electrolyte changes.

2. 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. 3.

Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity. 4. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL.

5. Correction of acidosis, if present, with intravenous sodium bicarbonate. 6.

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 150 words

HOW SUPPLIED Potassium Chloride Extended-release Tablets USP, 10 mEq Potassium chloride extended-release tablets, USP 10 mEq (equivalent to 750 mg) of potassium chloride are white to off-white, oblong shaped tablets, debossed with G10M on one side and plain on other side. Bottles of 100 NDC 68001-566-00 Bottles of 500 NDC 68001-566-03 Potassium Chloride Extended-release Tablets USP, 20 mEq Potassium chloride extended-release Tablets, USP 20 mEq (equivalent to 1500 mg) of potassium chloride are white to off-white, oblong shaped tablets, debossed with G20M on one side and scored on other side.

Bottles of 100 NDC 68001-567-00 Bottles of 500 NDC 68001-567-03 Store at 20° to 25°C (68° to 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 with a child-resistant closure. Keep tightly closed.

Manufactured by: Granules India Limited Hyderabad-500 084, India For Bluepoint Laboratories Rev. 09/2025 M.L.NO: 37/RR/AP/2003/F/R

📋 Description ~1 min read

DESCRIPTION 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. Potassium chloride extended-release tablets, USP 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 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 extended release tablets, USP 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 extended release tablets, USP 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 begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute.

The microencapsulated crystals are formulated to provide an extended-release of potassium chloride, USP Inactive Ingredients : croscarmellose sodium, ethyl cellulose, hydroxypropyl cellulose, microcrystalline cellulose and talc. FDA approved sample preparation in the assay differs from USP test. FDA approved dissolution test specifications differ from USP test.

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.