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Potassium Chloride 10 meq Capsule, Coated, Extended Release, 100-count — NDC 68180-0799-01 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 Capsule, Coated, Extended Release, 100-count — NDC 68180-799-01 (Billing 68180-0799-01)

by Lupin Pharmaceuticals, Inc. · 100 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE

This is a package of 100 capsules of Potassium Chloride 10 meq Capsule, Coated, Extended Release from Lupin Pharmaceuticals, Inc., no longer marketed (first marketed Jan 2016), no longer in the FDA NDC Directory; retail pharmacies pay about $0.1301 per capsule (NADAC).

NDC 68180-0799-01
🏷️ FDA NDC (as labeled) 68180-799-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1301 NADAC Per package$13.01 / 100 capsules Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.3468/unit — full pricing hub ↓
Product page 68180-0799-02 Also comes in: 500 capsules 68180-799-02 1000 capsules 68180-799-03
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

NDC database record

One package, one record: these facts belong to NDC 68180-799-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68180 labeler · 799 product · 01 package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC)
0368180798019
Medicaid fills, this package
215 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68180-799-01
Product NDC 68180-799
11-digit billing NDC 68180079901
NCPDP billing unit EA — each (per item)
RxCUI 312504, 315183
UNII 660YQ98I10
UPC 0368180798019
Application # ANDA203002
SPL Set ID 1f33bcfe-c28a-4800-9241-685d974a5d91
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 Discontinued
FDA listing status Discontinued by firm
Marketing start 2016-01-18
Route ORAL
Dosage form CAPSULE, COATED, EXTENDED RELEASE
Substance POTASSIUM CHLORIDE

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

GPI-14 79700030000210
GPI class Potassium Chloride ER
GCN Seq No 001248
GCN 03321
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 10 MEQ CAPSULE
FDB brand name Potassium Chloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001248
  • GCN: 03321
  • GPI-14 (Medi-Span): 79700030000210
  • HICL (First Databank): 000549
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 312504
Why two NDCs? The FDA registers this code as 68180-799-01 — 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 → 68180-0799-01. 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

Label name POTASSIUM CL ER 10 MEQ CAPSULE Ingredient Potassium Chloride
📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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 eaPer package
Retail pharmacies payNADAC · weekly $0.130 $13.01 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.3468 $34.68 / 100 capsules
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $0.155 $0.130
▼ Down 5% over the last 15 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
68180-0799-01 You're viewing this 100 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE $0.1301 / ea $13.01 2016-05-25 — Discontinued by firm
68180-0799-02 68180-799-02 Main listing 500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE $0.1301 / ea $65.07 2016-03-04 — Discontinued by firm
68180-0799-03 68180-799-03 1000 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE — — 2016-05-25 — Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1301 NADAC).

This pack accounts for about 20% of this product's recent Medicaid fills; most go to the 500 capsules pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule, coated, extended release in 1 bottle.
How does this package differ from NDC 68180-0799-02?
Both are Potassium Chloride 10 meq Capsule, Coated, Extended Release — the drug itself is identical. This page's package is the 100-count one, while NDC 68180-0799-02 is the 500 capsules package.
What NDC number is used to bill for this package of Potassium Chloride 10 meq Capsule, 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.

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 750 mg 59917-0103-01 Adare 100 capsules $0.130 — FDA listed +0%
Potassium Chloride 750 mg 68462-0357-01 Glenmark 100 capsules $0.130 — FDA listed —
Potassium Chloride 10 meqthis 68180-0799-01 Lupin 100 capsules $0.130 — Discontinued —
Potassium Chloride 750 mg 68001-0396-00 BluePoint 100 capsules $0.131 — FDA listed +0%
Potassium Chloride 750 mg 00904-7543-61 Major 1 capsule $0.137 AB Availability likely +6%
potassium chloride 750 mg 43547-0553-10 Solco 100 capsules $0.137 AB Availability likely +6%
Potassium Chloride 750 mg 50268-0671-13 AvPAK 1 capsule $0.137 AB Availability likely +6%
Potassium Chloride 750 mg 53746-0542-01 Amneal 100 capsules $0.137 AB Availability likely +6%
Potassium Chloride 750 mg 60687-0653-01 American 1 capsule $0.137 AB Availability likely +6%
Potassium Chloride 750 mg 62037-0560-01 Actavis 100 capsules $0.137 AB Availability likely +6%
Potassium Chloride 750 mg 63304-0090-01 Sun 100 capsules $0.137 AB Availability likely +6%
Potassium Chloride 750 mg 68001-0619-00 BluePoint 100 capsules $0.137 AB Availability likely +6%
Potassium Chloride 750 mg 70010-0148-01 Granules 100 capsules $0.137 AB Availability likely +6%
Potassium Chloride 750 mg 00615-8442-05 NCS 15 capsules — AB FDA listed —
Potassium Chloride 750 mg 16714-0824-01 Northstar 100 capsules — — FDA listed —
Potassium Chloride 750 mg 42291-0679-50 AvKARE 500 capsules — AB FDA listed —
Potassium Chloride 10 meq 50090-4734-09 A-S 90 capsules — — FDA listed —
Potassium Chloride 750 mg 50090-7469-00 A-S 30 capsules — AB FDA listed —
Potassium Chloride 750 mg 62207-0915-43 Granules 100 capsules — AB FDA listed —
potassium chloride 750 mg 68382-0854-01 Zydus 100 capsules — AB FDA listed —
Potassium Chloride 750 mg 70518-4050-00 REMEDYREPACK 30 capsules — AB FDA listed —
Potassium Chloride 750 mg 72789-0057-01 PD-Rx 100 capsules — AB 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 Blue / White
ShapeCapsule
ImprintLU;R51
Size24 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.

🧪 Avoiding an ingredient? See Potassium Chloride inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3DYK7UYZ62
    Ethylcellulose is a plant-fiber derivative used as a binder and film-coating agent in tablets and capsules. It helps hold ingredients together and can create a protective coating that controls how quickly the medicine dissolves.
  • UNII V7AD894FAZ
    A plant-based polymer used as a film coating on tablets and capsules to control how quickly the medicine dissolves in your digestive system. It also acts as a binder to hold ingredients together.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

12 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

LabelerLupin Pharmaceuticals, Inc.
Application holderLUPIN LTD
FDA applicationANDA203002 (ANDA)
Labeler code68180
First marketedJan 2016
Product typeHuman Prescription Drug
Portfolio404 products on file

More NDCs from Lupin Pharmaceuticals, Inc. labeler code 68180

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 🧬 Pharmacokinetics 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 82 words ▾

1 INDICATIONS AND USAGE Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children 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 capsules, USP contain potassium chloride, 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 ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Monitor serum potassium and adjust dosage accordingly ( 2.1 ) If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation.( 2.1 ) Treatment of hypokalemia : Adults: Typical doses range from 40 to 100 mEq/day in 2 to 5 divided doses; limit doses to 40 mEq per dose. (2.2) Pediatric patients: 2 to 4 mEq/kg/day in divided doses not to exceed 1 mEq/kg as a single dose or 20 mEq, whichever is lower; if deficits are severe or ongoing losses are great, consider intravenous therapy.( 2.3 ) Maintenance or Prophylaxis of hypokalemia : Adults: Typical dose is 20 mEq per day ( 2.2 ) Pediatric patients: Typical dose is 1 mEq/kg/day.( 2.3 )

2.1Administration and Monitoring If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust dosages accordingly. 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 with meals and with a full glass of water or other liquid.

Do not take on an empty stomach because of the potential for gastric irritation [see Warnings and Precautions ( 5.1 )]. Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of water or juice to ensure complete swallowing of the microcapsules.

Do not added to hot foods. Any microcapsule/food mixture should be used immediately and not stored for future use.

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

2.3Pediatric Dosing Pediatric patients aged birth to 16 years old: Dosage must be adjusted to the individual needs of each patient. Do not exceed as a single dose 1 mEq/kg or 20 mEq, whichever is lower. Treatment of hypokalemia: The recommended initial dose is 2 to 4 mEq/kg/day in divided doses. If deficits are severe or ongoing losses are great, consider intravenous therapy. Maintenance or Prophylaxis: Typical dose is 1 mEq/kg/day.

💊 Dosage Forms and Strengths 98 words ▾

3 DOSAGE FORMS AND STRENGTHS Potassium chloride extended-release capsules USP, 600 mg (equivalent to 8 mEq of potassium) are size '00' opaque white color hard gelatin capsules imprinted with 'LU' on cap and 'R51' on body in black ink containing white to off white coated pellets. Potassium chloride extended-release capsules USP, 750 mg (equivalent to 10 mEq of potassium) are size '00 EL' opaque blue color hard gelatin capsules imprinted with 'LU' on cap and 'R52' on body in white ink containing white to off white coated pellets.

Extended-release capsules: 600 mg (8mEq) and 750 mg (10 mEq)

⛔ Contraindications 22 words ▾

4 CONTRAINDICATIONS Potassium chloride extended-release capsules are contraindicated in patients on amiloride or triamterene. Concomitant use with triamterene and amiloride.( 4 )

⚠️ Warnings and Cautions 117 words ▾

5 WARNINGS AND PRECAUTIONS Gastrointestinal Irritation: 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 if the drug is 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 capsules and consider possibility of ulceration, obstruction or perforation.

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

🤒 Adverse Reactions 119 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, and perforation. 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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🔄 Drug Interactions 123 words ▾

7 DRUG INTERACTIONS Triamterene and amiloride: Concomitant use is contraindicated ( 7.1 ) Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia.( 7.2 ) Nonsteroidal Anti-inflammatory drugs (NSAIDS): Monitor for hyperkalemia ( 7.3 )

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

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

7.3Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) NSAIDs may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients taking NSAIDS.

👥 Use in Specific Populations ~2 min read ▾

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

8.1Pregnancy Risk Summary There are no human data related to use of potassium chloride extended-release capsules during pregnancy and animal reproductive 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 oral potassium 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 Clinical trial data from published literature have demonstrated the safety and effectiveness of potassium chloride in children with diarrhea and malnutrition from birth to 18 years.

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

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

8.6Cirrhotics Based on publish 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 [see Clinical Pharmacology ( 12.3 )] .

8.7Renal Impairment Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on RAAS inhibitors or nonsteroidal anti-inflammatory drugs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [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 capsules during pregnancy and animal reproductive 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 29 words ▾

8.4Pediatric Use Clinical trial data from published literature have demonstrated the safety and effectiveness of potassium chloride in children with diarrhea and malnutrition from birth to 18 years.

🧓 Geriatric Use 140 words ▾

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

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

🆘 Overdosage ~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. 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 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).

10.2Treatment Treatment measures for hyperkalemia include the following: Monitor closely for arrhythmias and electrolyte changes. Eliminate foods and medications containing potassium and any agents with potassium- sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements, and many others. Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.

Administer 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL. Correct acidosis, if present, with intravenous sodium bicarbonate. Use exchange resins, hemodialysis, or peritoneal dialysis.

In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. 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 201 words ▾

12 CLINICAL PHARMACOLOGY

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

12.3Pharmacokinetics Each crystal of KCl is microencapsulated and allows for the controlled release of potassium and chloride ions over an eight- to ten-hour period. Specific Populations Cirrhotics Based on publish 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.

🧬 Mechanism of Action 131 words ▾

12.1Mechanism of Action The potassium ion (K+) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes, including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 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 117 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium chloride Extended-Release Capsules USP contain 600 mg and 750 mg of potassium chloride (equivalent to 8 mEq and 10 mEq of potassium, respectively). Table 1: How Supplied Dose Color Printing NDC Bottle Count 100 500 600 mg (equivalent to 8 mEq of potassium) opaque white "R51" - body 68180-798-01 68180-798-02 - "LU" - cap 100 500 1000 750 mg (equivalent to 10 mEq of potassium) opaque blue "R52" - body 68180-799-01 68180-799-02 68180-799-03 "LU" - cap Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature] .

Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure. Rx only

📋 Description 162 words ▾

11 DESCRIPTION Potassium chloride extended-release capsules USP, 8 mEq and 10 mEq are oral dosage forms of microencapsulated potassium chloride containing 600 and 750 mg, respectively, of potassium chloride USP equivalent to 8 and 10 mEq of potassium. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55.

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. The inactive ingredients are ethyl cellulose, triethyl citrate, talc, sodium lauryl sulfate, gelatin, titanium dioxide, shellac, propylene glycol, potassium hydroxide. In addition 600 mg [equivalent to 8 mEq of potassium] capsule also contain black iron oxide and 750 mg [equivalent to 10 mEq of potassium] capsule also contain FD&C blue #1 and FD&C red # 40.

FDA approved dissolution test specifications differ from USP.

💬 Information for Patients 63 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients to take each dose with meals and with a full glass of water or other liquid. Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal toxicity is noticed. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA Revised: June 2023 ID: 273774

🧬 Pharmacokinetics 67 words ▾

12.3Pharmacokinetics Each crystal of KCl is microencapsulated and allows for the controlled release of potassium and chloride ions over an eight- to ten-hour period. Specific Populations Cirrhotics Based on publish 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.

📄 Package Label / Principal Display Panel 37 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Potassium Chloride Extended-Release Capsules USP Rx only 600mg (8 mEq K) NDC 68180-798-01 100 capsules Potassium Chloride Extended-Release Capsules USP Rx only 750mg (10 mEq K) NDC 68180-799-01 100 capsules Imgae-01 Image 02

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

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 this package alone, 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
215
Units reimbursed last 4 qtrs
8.3K
Gross reimbursed last 4 qtrs
$2.9K
Avg / prescription
$13.38
Avg / unit
$0.3468
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$0.3468
gross reimbursed
vs
NADAC / ea
$0.1301
acquisition cost
=
Spread
+$0.2167
+167% 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 ⓘ
80% FFS 20% MCO
Fee-for-service · 172 Rx Managed care · 43 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 2,760 units · 14.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 297 units · 2.3 per 100k residents PA New Jersey: 510 units · 5.5 per 100k residents NJ Massachusetts: no data reported MA California: 1,559 units · 4.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 630 units · 13.9 per 100k residents KY West Virginia: 2,541 units · 144 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.3144
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 West Virginia 144 /100k
2 New York 14.1 /100k
3 Kentucky 13.9 /100k
4 New Jersey 5.5 /100k
5 California 4.0 /100k
6 Pennsylvania 2.3 /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 capsules68180-0799-02 875 Rx · $33,457
100 capsules this page68180-0799-01 215 Rx · $2,877
1000 capsules68180-0799-03 No Medicaid data
Drug total (last 4 qtrs): 1,090 Rx · 94,166 units · $36,335 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Potassium Chloride — the program that covers self-administered drugs. 42 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Potassium Chloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$78.71M
Claims incl. refills
3.7M
Beneficiaries
2.4M
Spend / beneficiary
$33.46
Spend / claim
$21.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 500 capsules (68180-0799-02), 1000 capsules (68180-0799-03). 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.
← 68180-0797-01 · Lupin 68180-0801-36 · 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.