NDC 60687-466 Potassium Chloride

Potassium Chloride

NDC Product Code 60687-466

NDC Code: 60687-466

Proprietary Name: Potassium Chloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Potassium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

YELLOW (C48330)
Shape: OVAL (C48345)
15 MM
Score: 1

NDC Code Structure

  • 60687 - American Health Packaging

NDC 60687-466-01

Package Description: 100 BLISTER PACK in 1 BOX, UNIT-DOSE > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (60687-466-11)

NDC Product Information

Potassium Chloride with NDC 60687-466 is a a human prescription drug product labeled by American Health Packaging. The generic name of Potassium Chloride is potassium chloride. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Labeler Name: American Health Packaging

Dosage Form: Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Potassium Chloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: American Health Packaging
Labeler Code: 60687
FDA Application Number: NDA018279 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA AUTHORIZED GENERIC - A product marketed as a “generic” drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-15-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Potassium Chloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

2.1 Monitoring 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 (
Swallow tablets whole without crushing, chewing or sucking.

2.2 Dosing

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 40-100 mEq per day.

Prevention of hypokalemia: Typical dose is 20 mEq per day.

3 Dosage Forms And Strengths

  • 8 mEq (600 mg): Round, yellow, debossed extended-release tablets with “K-TAB” on one side
  • 10 mEq (750 mg): Ovaloid, yellow, debossed extended-release tablets with “10” on one side and “K‑TAB” on the other side
  • 10 mEq (750 mg): Ovaloid, yellow, debossed extended-release tablets with the “a” logo on one side and “K‑TAB” on the other side
  • 20 mEq (1500 mg): Ovaloid, white, debossed extended-release tablets with “K-TAB” on one side

4 Contraindications

Potassium chloride is contraindicated in patients on triamterene or amiloride.

5.1 Gastrointestinal 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 (

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 (
Skin rash has been reported rarely.

7.1 Triamterene And Amiloride

Use with triamterene or amiloride can produce severe hyperkalemia. Avoid concomitant use
[see Contraindications (

7.2 Renin-Angiotensin-Aldosterone System Inhibitors

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

7.3 Nonsteroidal Anti-Inflammatory Drugs

Nonsteroidal anti-inflammatory drugs (NSAIDs) may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients receiving concomitant NSAID therapy.

8.1 Pregnancy

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 2-4% and 15-20%, respectively.

8.2 Lactation

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.

8.4 Pediatric Use

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

8.5 Geriatric 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.

8.6 Cirrhotics

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.

8.7 Renal 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 (
. The serum potassium level should be monitored frequently. Renal function should be assessed periodically.

10.1 Symptoms

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 (
Warnings and Precautions (
Hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss P-waves, depression of S-T segments, and prolongation of the QT intervals). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

10.2 Treatment

  • Treatment measures for hyperkalemia include the following:Monitor closely for arrhythmias and electrolyte changes.
  • 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.
  • Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
  • Administer intravenously 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.

11 Description

Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride containing 600 mg, 750 mg and 1500 mg of potassium chloride, USP, equivalent to 8 mEq, 10mEq 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.The 8 mEq and 10 mEq tablets also contain castor oil, cellulosic polymers, colloidal silicon dioxide, D&C Yellow No. 10, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin, and vitamin E.The 20 mEq tablets also contain castor oil, cellulosic polymers, colloidal silicon dioxide, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin, and vitamin E.

12.1 Mechanism 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.

12.2 Pharmacokinetics

Specific PopulationsCirrhotics
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 (

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

16 How Supplied/Storage And Handling

Potassium chloride extended-release tablets, USP contain 750 mg of potassium chloride (equivalent to 10 mEq of potassium). Potassium chloride extended-release tablets, USP are provided as extended-release, film-coated tablets.Potassium chloride extended-release 750 mg tablets (10 mEq) are ovaloid, yellow, debossed with “10” on one side and “K TAB” on the other side. They are supplied as follows:

Unit dose packages of 100 (10 x 10) NDC 60687-466-01
Recommended Storage
Store at room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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.

Packaging Information

American Health Packaging unit dose blisters (see
HOW SUPPLIED section) contain drug product from Zydus Pharmaceuticals USA Inc. as follows:

(750 mg (10 mEq) / 100 UD) NDC 60687-466-01 packaged from NDC 68382-320
Distributed by:
American Health Packaging
Columbus, OH 43217

Package/Label Display Panel – Carton – 10 Meq (750 Mg)

NDC 60687-
Potassium Chloride

Tablets, USP
10 mEq (750 mg)100 Film-Coated Tablets (10 x 10)        Rx OnlyEach Tablet Contains:
750 mg potassium chloride (equivalent to 10 mEq).
Usual Dosage: See package insert for full prescribing

Store at 20° to 25°C (68° to 77°F); excursions permitted

between 15° to 30°C (59° to 86°F) [see USP Controlled

Room Temperature].
Keep this and all drugs out of reach of children.FOR YOUR PROTECTION: Do not use if blister is torn or

The drug product contained in this package is from

NDC # 68382-320, Zydus Pharmaceuticals USA Inc.
Packaged and Distributed by:

American Health Packaging

Columbus, Ohio 43217


Package/Label Display Panel – Blister – 10 Meq (750 Mg)

Potassium Chloride Extended-

Release Tablet, USP
10 mEq (750 mg)

* Please review the disclaimer below.