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Potassium Chloride 1500 mg Tablet, Film Coated, Extended Release, 15-count — NDC 00615-8580-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Potassium Chloride 1500 mg Tablet, Film Coated, Extended Release, 15-count — NDC 0615-8580-05 (Billing 00615-8580-05)

by NCS HealthCare of KY, LLC dba Vangard Labs · 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

This is a package of 15 tablets of Potassium Chloride 1500 mg Tablet, Film Coated, Extended Release from NCS HealthCare of KY, LLC dba Vangard Labs, marketed since Feb 2020 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00615-8580-05
🏷️ FDA NDC (as labeled) 0615-8580-05 billing pads the labeler segment with a zero
This package
Contains15-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.2885/unit — full pricing hub ↓
Main listing for product 0615-8580 · Also comes in: 30 tablets 0615-8580-39
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) 0615-8580-05
Product NDC 0615-8580
11-digit billing NDC 00615858005
RxCUI 198116
UNII 660YQ98I10
Application # ANDA212561
SPL Set ID 542e16b0-44db-490f-b44e-4c88a6e3d8b8
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 2020-02-01
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance POTASSIUM CHLORIDE
TE code (Orange Book) AB3 · RLD · RS
Quick answers
  • RxCUI (RxNorm): 198116
Why two NDCs? The FDA registers this code as 0615-8580-05 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00615-8580-05. 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.

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
  • 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 · Q2 2026 $0.2885 $4.33 / 15 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 Marketing startMarketing endStatus
00615-8580-05 You're viewing this Main listing 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 2025-09-16 — Active
00615-8580-39 0615-8580-39 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 2025-09-16 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 15-count package — 15 tablet, film coated, extended release in 1 blister pack.
How does this package differ from NDC 00615-8580-39?
Both are Potassium Chloride 1500 mg Tablet, Film Coated, Extended Release — the drug itself is identical. This page's package is the 15-count one, while NDC 00615-8580-39 is the 30 tablets package.
What NDC number is used to bill for this package of Potassium Chloride 1500 mg Tablet, Film Coated, 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
potassium chloride 1500 mg 68462-0472-01 Glenmark 100 tablets $0.141 AB1 Discontinued —
Potassium Chloride 1500 mg 31722-0135-01 Camber 100 tablets $0.141 AB1 Availability likely —
Potassium Chloride 1500 mg 00832-5325-10 Upsher-SmithLaboratories, 1000 tablets $0.141 AB1 Availability likely —
Potassium Chloride 1500 mg 00904-7293-61 Major 1 tablet $0.141 — Availability likely —
potassium chloride 1500 mg 72603-0338-01 Northstar 100 tablets $0.141 AB1 Discontinued —
Klor-Con M 1500 mg 00245-5319-01 Upsher-Smith 1 tablet $0.142 AB1 Availability likely —
Potassium Chloride Extended-Release 1500 mg 24979-0232-01 Upsher-Smith 100 tablets $0.186 AB3 Availability likely —
Potassium Chloride 1500 mg 70436-0153-01 Slate 100 tablets $0.186 AB3 Availability likely —
Potassium chloride 1500 mg 72888-0076-01 Advagen 100 tablets $0.186 — Availability likely —
Potassium Chloride 1500 mgthis 00615-8580-05 NCS 15 tablets — AB3 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 59651-0431-01 Aurobindo 100 tablets — — FDA listed —
Potassium Chloride 1500 mg 68382-0740-01 Zydus 100 tablets — AB1 FDA listed —
Potassium Chloride 1500 mg 70771-1600-00 Zydus 1000 tablets — AB1 FDA listed —
Potassium Chloride 1500 mg 50090-5665-00 A-S 30 tablets — — 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 1500 mg 50090-7456-00 A-S 90 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 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 1500 mg 67296-2131-02 Redpharm 20 tablets — AB1 FDA listed —
Potassium Chloride 1500 mg 67296-2243-06 Redpharm 30 tablets — AB1 FDA listed —
Potassium Chloride 1500 mg 50090-6253-00 A-S 30 tablets — AB1 FDA listed —
Klor-Con M 1500 mg 55154-5634-00 Cardinal 1 tablet — AB1 FDA listed —
potassium chloride 1500 mg 50090-3700-00 A-S 30 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 —
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 1500 mg 42291-0507-01 AvKARE 100 tablets — AB1 FDA listed —
Potassium Chloride 1500 mg 71335-2045-01 Bryant 30 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

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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
ImprintYH155
Size2 mm
ScoringNot scored
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 Z82Y2C65EA
    Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 32K497ZK2U
    Polyvinyl acetate is a synthetic plastic polymer derived from vinyl acetate. It acts as a binder and film-forming agent in medicines, helping to hold ingredients together and create protective coatings on tablets or capsules.
  • 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.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerNCS HealthCare of KY, LLC dba Vangard Labs
Application holderYICHANG HUMANWELL PHARMACEUTICAL CO LTD
FDA applicationANDA212561 (ANDA)
Labeler code00615
First marketedFeb 2020
Product typeHuman Prescription Drug
Portfolio326 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 74 words ▾

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

(1)

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION • Monitor serum potassium and adjust dosages accordingly (2.1) • If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation (2.1) • Take with meals and with a glass of water or other liquid. Swallow tablets whole. (2.1) • Treatment of hypokalemia: Typical dose range is 40 to 100 mEq per day in divided doses.

Limit doses to 20 mEq per dose. (2.2) • Prevention of hypokalemia: Typical dose is 20 mEq per day (2.2)

2.1Monitoring and Administration If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust the dose based on serum potassium level. Monitor serum potassium periodically during maintenance therapy to ensure potassium remains in desired range.

The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms, and the clinical status of the patient. Correct volume status, acid-base balance, and electrolyte deficits as appropriate. Administration Take potassium chloride extended-release tablets with meals and with a glass of water or other liquid.

Do not take on an empty stomach because of its potential for gastric irritation [ see Warnings and Precautions (5.1) ] . Swallow tablets whole without crushing, chewing or sucking.

2.2Dosing Dosage must be adjusted to the individual needs of each patient. Dosages greater than 20 mEq per day should be divided such that no more than 20 mEq is given in a single dose. Treatment of hypokalemia: Typical dose range is 40 to 100 mEq per day. Prevention of hypokalemia: Typical dose is 20 mEq per day.

💊 Dosage Forms and Strengths 75 words ▾

3 DOSAGE FORMS AND STRENGTHS Potassium Chloride Extended-Release Tablets USP are supplied as: • 10 mEq (750 mg): Yellow, oval, biconvex, film-coated tablets, debossed with “YH156” on one side and plain on the other side. • 20 mEq (1,500 mg): White to off-white, oval, biconvex, film-coated tablets, debossed with “YH155” on one side and plain on the other side. • 10 mEq (750 mg) oral tablets (3) • 20 mEq (1,500 mg) oral tablets (3)

⛔ Contraindications 21 words ▾

4 CONTRAINDICATIONS Potassium chloride is contraindicated in patients on triamterene or amiloride. • Concomitant use with triamterene and amiloride (4, 7.1)

⚠️ Warnings and Cautions 135 words ▾

5 WARNINGS AND PRECAUTIONS • Gastrointestinal Adverse Reactions: Can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly when in prolonged contact with the gastrointestinal mucosa. Take with meals. (5.1)

5.1Gastrointestinal Adverse Reactions Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly when the drug remains in contact with the gastrointestinal mucosa for a prolonged period of time. Consider the use of liquid potassium in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders. If severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs, discontinue potassium chloride extended-release tablets and consider possibility of ulceration, obstruction or perforation.

Potassium chloride extended-release tablets should not be taken on an empty stomach because of its potential for gastric irritation [see Dosage and Administration (2.1) ] .

🤒 Adverse Reactions 128 words ▾

6 ADVERSE REACTIONS The following adverse reactions have been identified with use of oral potassium salts. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.

There have been reports of hyperkalemia and of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, perforation [see Warnings and Precautions (5.1) and Overdosage (10) ] . Skin rash has been reported rarely. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea (6) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 115 words ▾

7 DRUG INTERACTIONS • Renin-angiotensin-aldosterone system inhibitors: Monitor for hyperkalemia (7. 2) • Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia (7.3)

7.1Triamterene and Amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Avoid concomitant use [see Contraindications (4) ] .

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

7.3Nonsteroidal Anti-Inflammatory Drugs 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.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS • Cirrhosis: Initiate therapy at the low end of the dosing range (8.6) • Renal Impairment: Initiate therapy at the low end of the dosing range (8.7)

8.1Pregnancy Risk Summary There are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

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

8.4Pediatric Use Safety and effectiveness of potassium chloride extended-release tablets in children have not been established.

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

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6Cirrhotics Doses of potassium in patients with cirrhosis produce a larger increase in potassium levels compared to the response in normal patients. Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently.

8.7Renal Impairment Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on RAAS inhibitors or NSAIDs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see Drug Interactions (7.2, 7.3) ] . The serum potassium level should be monitored frequently.

Renal function should be assessed periodically.

🤰 Pregnancy 99 words ▾

8.1Pregnancy Risk Summary There are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use Safety and effectiveness of potassium chloride extended-release tablets in children have not been established.

🧓 Geriatric Use 142 words ▾

8.5Geriatric Use Clinical studies of potassium chloride extended-release tablets 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 ▾

10 OVERDOSAGE

10.1Symptoms The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, potentially fatal hyperkalemia can result [see Contraindications (4) and Warnings and Precautions (5.1) ] . Hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5 to 8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss P-waves, depression of S-T segments, and prolongation of the QT intervals).

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

10.2Treatment Treatment measures for hyperkalemia include the following: 1. Monitor closely for arrhythmias and electrolyte changes. 2.

Eliminate foods and medications containing potassium and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements, and many others. 3. Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.

4. Administer intravenously 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL. 5.

Correct acidosis, if present, with intravenous sodium bicarbonate. 6. Use exchange resins, hemodialysis, or peritoneal dialysis.

In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. 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 189 words ▾

12 CLINICAL PHARMACOLOGY

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

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

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

12.2Pharmacokinetics Specific Populations Cirrhotics Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load [see Use in Specific Populations (8.6) ] .

🧬 Mechanism of Action 134 words ▾

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

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

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

📦 How Supplied / Storage and Handling 92 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride Extended-Release Tablets USP contain1,500 mg of potassium chloride (equivalent to 20 mEq of potassium, respectively). Potassium Chloride Extended-Release Tablets USP are provided as extended-release film-coated tablets. Strength Description Blistercard Quantity NDC# 20 mEq (1,500 mg) White to off-white, oval, biconvex, film-coated tablets, debossed with "YH155" on one side and plain on the other side.

30 0615-8580-39 15 0615-8580-05 Recommended Storage Store at room temperature 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a USP tight container with a child-resistant closure.

📋 Description 182 words ▾

11 DESCRIPTION Potassium Chloride Extended-Release Tablets USP are a solid oral dosage form of potassium chloride containing 750 mg and 1,500 mg of potassium chloride, USP, equivalent to 10 mEq and 20 mEq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. The chemical name 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.

Each tablet contains the labeled amount of potassium chloride and the following inactive ingredients: colloidal silicon dioxide, hydrogenated vegetable oil, microcrystalline cellulose, polyvinyl acetate, povidone, sodium lauryl sulfate and triethyl citrate. The coating material of 10 mEq (750 mg) product contains ferrosoferric oxide, iron oxide yellow, mono- and di-glycerides, polyethylene glycol polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide. The coating material of 20 mEq (1500 mg) product contains hypromellose and talc.

FDA approved assay test differs from USP. FDA approved dissolution test specifications differ from USP.

💬 Information for Patients 106 words ▾

17 PATIENT COUNSELING INFORMATION • Inform patients to take each dose with meals and with a full glass of water or other liquid, and to not crush, chew, or suck the tablets. • Advise patients to seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed. • Inform patients that the wax tablet is not absorbed and may be excreted intact in the stool. If the patient observes this, it is not an indication of lack of effect. Manufactured by: Yichang Humanwell Oral Solid Dosage Plant Yichang, Hubei, China 443001 Distributed by: Slate Run Pharmaceuticals, LLC Columbus, Ohio 43215 Revised: 03/2024 10000194/02

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) ✓ 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 NCS HealthCare of KY, LLC dba Vangard Labs. 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 1 other package presentation of this same product, including 30 tablets (00615-8580-39). 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?
NCS HealthCare of KY, LLC dba Vangard Labs 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.
← 00615-8579-39 · NCS 00615-8581-39 · NCS →
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.