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Potassium Chloride 10 meq Tablet, Extended Release, 90-count — NDC 43386-0915-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Potassium Chloride 10 meq Tablet, Extended Release, 90-count — NDC 43386-915-09 (Billing 43386-0915-09)

by Lupin Pharmaceuticals,Inc. · 90 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 90 tablets of Potassium Chloride 10 meq Tablet, Extended Release from Lupin Pharmaceuticals,Inc., marketed since Jan 2016 and currently FDA-listed.

NDC 43386-0915-09
🏷️ FDA NDC (as labeled) 43386-915-09 billing pads the product segment with a zero
This package
Contains90-count Pack sizes4 compare ↓
Product page 43386-0915-01 Also comes in: 100 tablets 43386-915-01 500 tablets 43386-915-05 1000 tablets 43386-915-10
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43386-915-09
Product NDC 43386-915
11-digit billing NDC 43386091509
RxCUI 1801294, 1801298
UNII 660YQ98I10
Application # ANDA206347
SPL Set ID fe08221d-74d5-490a-8db4-eaf3ed20b289
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 2016-01-21
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance POTASSIUM CHLORIDE
TE code (Orange Book) AB1 · RLD · RS

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

GPI-14 79700030100430
GPI class Potassium Chloride Crys ER
Quick answers
  • GPI-14 (Medi-Span): 79700030100430
  • RxCUI (RxNorm): 1801294
Why two NDCs? The FDA registers this code as 43386-915-09 — 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 → 43386-0915-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Potassium class.

Drug family (ATC) Potassium, Electrolyte solutions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It treats and prevents low potassium. Doctors often use it when you take diuretics or lose fluids through diarrhea or vomiting and food alone isn't enough. The injection is used in...
  • Take tablets and capsules with meals, not on an empty stomach, to protect your stomach. Powders and liquids need to be diluted first. Follow your prescriber's directions and keep y...
  • The most common issue is stomach upset. Taking it with food helps. Call your doctor if you have severe vomiting, belly pain, swelling or bleeding, since that can mean an ulcer or b...
  • Check with me first. Blood pressure medicines such as ACE inhibitors and ARBs, spironolactone, and NSAIDs can raise potassium. Triamterene and amiloride should be avoided with it.
📖 Read our full Potassium Chloride guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 100 tablets 500 tablets 1000 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
43386-0915-01 43386-915-01 Main listing 100 TABLET, EXTENDED RELEASE in 1 BOTTLE $0.1495 / ea $14.95 2016-01-21 — Active
43386-0915-05 43386-915-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE — — 2016-01-21 — Active
43386-0915-09 You're viewing this 90 TABLET, EXTENDED RELEASE in 1 BOTTLE — — 2016-01-21 — Active
43386-0915-10 43386-915-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE $0.1495 / ea $149.51 2017-01-30 — Active

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet, extended release in 1 bottle.
How does this package differ from NDC 43386-0915-01?
Both are Potassium Chloride 10 meq Tablet, Extended Release — the drug itself is identical. This page's package is the 90-count one, while NDC 43386-0915-01 is the 100 tablets package.
What NDC number is used to bill for this package of Potassium Chloride 10 meq Tablet, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Chloride 10 meq 00378-4561-05 Mylan 500 tablets $0.083 AB2 Availability likely —
Potassium Chloride 750 mg 00832-5324-10 Upsher-SmithLaboratories, 1000 tablets $0.127 AB1 Availability likely —
Potassium Chloride Extended-Release 750 mg 00904-7547-61 Major 1 tablet $0.127 AB1 Availability likely —
Potassium Chloride 750 mg 31722-0133-01 Camber 100 tablets $0.127 AB1 Availability likely —
Potassium Chloride Extended-Release 750 mg 60687-0632-01 American 1 tablet $0.127 AB1 Availability likely —
Potassium Chloride Extended-Release 750 mg 63304-0076-01 Sun 100 tablets $0.127 AB1 Availability likely —
Potassium Chloride Extended-release 750 mg 68001-0566-00 Bluepoint 100 tablets $0.127 AB1 Availability likely —
potassium chloride 750 mg 68462-0471-01 Glenmark 100 tablets $0.127 AB1 Discontinued —
Potassium Chloride Extended-release 750 mg 70010-0136-01 Granules 100 tablets $0.127 AB1 Availability likely —
potassium chloride 750 mg 72603-0337-01 Northstar 100 tablets $0.127 AB1 Availability likely —
Klor-Con M 750 mg 00245-5317-01 Upsher-Smith 1 tablet $0.133 AB1 Availability likely —
Potassium Chloride 750 mg 00904-7292-61 Major 1 tablet $0.135 — Discontinued —
Potassium Chloride 10 meq 62037-0710-01 Actavis 100 tablets $0.135 AB1 Discontinued —
Potassium Chloride 750 mg 63739-0972-10 Mckesson 10 tablets $0.150 AB1 Discontinued —
Potassium Chloride Extended-Release 750 mg 00615-8399-05 NCS 15 tablets — AB1 FDA listed —
Potassium Chloride 10 meqthis 43386-0915-09 Lupin 90 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 43547-0549-10 Solco 100 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 59651-0429-01 Aurobindo 100 tablets — — FDA listed —
Potassium Chloride Extended-release 750 mg 62207-0726-43 Granules 100 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 63629-1072-01 Bryant 100 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 63629-1073-01 Bryant 1000 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 63629-1074-01 Bryant 90 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 63629-1075-01 Bryant 500 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 68382-0861-01 Zydus 100 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 70518-3024-01 REMEDYREPACK 90 tablets — AB1 FDA listed —
Potassium Chloride Extended-release 750 mg 70518-4095-02 REMEDYREPACK 30 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 70771-1599-00 Zydus 1000 tablets — AB1 FDA listed —
potassium chloride 750 mg 71335-1781-01 Bryant 30 tablets — AB1 Discontinued —
Potassium Chloride Extended-Release 750 mg 71335-1900-01 Bryant 30 tablets — AB1 FDA listed —
Potassium Chloride Extended-release 750 mg 71335-2503-01 Bryant 30 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 71335-2607-01 Bryant 30 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 71335-2866-01 Bryant 100 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 71335-2913-01 Bryant 500 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 71335-2958-01 Bryant 90 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 72162-1786-00 Bryant 1000 tablets — AB1 FDA listed —
Potassium Chloride ER 750 mg 72189-0648-04 Direct_Rx 4 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 72865-0194-01 XLCare 100 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 72888-0097-00 Advagen 1000 tablets — AB1 FDA listed —
Potassium Chloride Extended-release 750 mg 82804-0109-30 Proficient 30 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 82868-0027-90 Northwind 90 tablets — AB1 FDA listed —
Potassium Chloride 10 meq 50090-6635-00 A-S 90 tablets — AB2 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

🏛️
2016
On the market since
Jan 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

What it looks like

Color White
ShapeOval
ImprintP20
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerLupin Pharmaceuticals,Inc.
Application holderNOVEL LABORATORIES INC
FDA applicationANDA206347 (ANDA)
Labeler code43386
First marketedJan 2016
Product typeHuman Prescription Drug
Portfolio89 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 211 words ▾

INDICATIONS AND USAGE BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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 tablet 20 mEq provides 1500 mg of potassium chloride equivalent to 20 mEq of potassium. Each potassium chloride extended-release tablet 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: 1. Break the tablet in half and take each half separately with a glass of water.

2. Prepare an aqueous (water) suspension as follows: 1. Place the whole tablet(s) in approximately one-half 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 extended-release tablet that is not taken immediately should be discarded. The use of other liquids for suspending potassium chloride extended-release tablets is not recommended.

⛔ Contraindications 179 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 ).

Extended-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 Extended-release Tablets ( 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 164 words ▾

WARNINGS Voriconazole treatment-related visual disturbances are common. In therapeutic trials, approximately 21% of patients experienced abnormal vision, color vision change and/or photophobia. Visual disturbancesmay be associated with higher plasma concentrations and/or doses.

There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema [ see Warnings and Precautions (5.3)] . The mechanism of action of the visual disturbance is unknown, although the site of action is most likely to be within the retina. In a study in healthy subjects investigating the effect of 28-day treatment with voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude, a decrease in the visual field, and an alteration in color perception.

The ERG measures electrical currents in the retina. The effects were noted early in administration of voriconazole and continued through the course of study drug dosing. Fourteen days after end of dosing, ERG, visual fields and color perception returned to normal [ see Warnings and Precautions (5.7) ].

🤒 Adverse Reactions 89 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 mEq/L 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 mEq/L to 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 to 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 154 words ▾

HOW SUPPLIED Potassium chloride extended-release tablets USP 20 mEq K are supplied as oblong white to off-white colored, scored for flexibility of dosing, debossed "P 20" on one side and bisected on other side. Bottles of 90: 43386-917-09 Bottles of 100: 43386-917-01 Bottles of 400: 43386-917-04 Bottles of 500: 43386-917-05 Bottles of 1000: 43386-917-10 Potassium chloride extended-release tablets USP 10 mEq K are supplied as oblong, white to off-white colored tablets, debossed "P 10" on one side and plain on other side.

Bottles of 90: 43386-915-09 Bottles of 100: 43386-915-01 Bottles of 500: 43386-915-05 Bottles of 1000: 43386-915-10 Keep tightly closed. Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted between 15 o to 30 o C (59 o to 86 o F) [See USP Controlled Room Temperature]. Manufactured by: Novel Laboratories, Inc Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc Baltimore, MD 21202 PI9170000202 Revised: 11/2016

📋 Description ~1 min read ▾

DESCRIPTION Potassium chloride extended-release tablet USP 20 mEq K 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. Potassium chloride extended-release tablet USP 10 mEq K 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 crystalline powder.

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 tablet 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 tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride.

Inactive Ingredients : microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending.

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

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.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lupin Pharmaceuticals,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 3 other package presentations of this same product, including 100 tablets (43386-0915-01), 500 tablets (43386-0915-05), 1000 tablets (43386-0915-10). 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?
Lupin Pharmaceuticals,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.
← 43386-0871-01 · Lupin 43386-0917-01 · Lupin →
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.