TheraRadar
Data updated: May 26, 2026

POTASSIUM CHLORIDE IN PLASTIC CONTAINER (potassium chloride)

Other Approved 1985-01-25

Potassium Chloride helps patients with low blood potassium levels, a condition known as hypokalemia. It is used for both treating existing deficiencies and preventing them from occurring, especially when dietary changes or adjusting other medications like diuretics are not sufficient. This supplement also helps those who have hypokalemia alongside metabolic alkalosis.

Source: FDA Label • Fresenius Kabi

How POTASSIUM CHLORIDE IN PLASTIC CONTAINER Works

This medication works by replenishing potassium ions, the principal intracellular cations in body tissues. These ions are essential for numerous physiological processes, including maintaining intracellular tonicity, transmitting nerve impulses, and contracting cardiac, skeletal, and smooth muscles. They also support normal renal function. By providing these ions, the drug helps maintain the necessary concentration gradient between the intracellular environment and the blood plasma.

Source: FDA Label
1
Indication
--
Phase 3 Trials
41
Years on Market

Details

Status
Prescription
First Approved
1985-01-25
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: POTASSIUM CHLORIDE

POTASSIUM CHLORIDE IN PLASTIC CONTAINER Approval History

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Original
New Indication
New Form
Label Update
32 FDA actions from 1985 to 2022
Dec 2022 SUPPL
Label · Labeling
Nov 2022 SUPPL
Label · Labeling
May 2007 SUPPL
Mfg · Manufacturing (CMC)

What POTASSIUM CHLORIDE IN PLASTIC CONTAINER Treats

2 indications

POTASSIUM CHLORIDE IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypokalemia
  • Metabolic Alkalosis
Source: FDA Label

POTASSIUM CHLORIDE IN PLASTIC CONTAINER Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

8 trials
Trial Sponsor ID Phase Status Title
NCT07238400 CARDAMOM 2025P001799 R01HL181150 Ph 2 recruiting Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia
NCT04316611 POTACREH APHP180577 2019-002544-24 Ph 2 withdrawn Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation
NCT02450773 201501157 Ph 2 withdrawn Prevention of Severe Postpartum Hypertension
NCT03627130 NITRATE-CIN 18/1 Ph 2 completed The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy
NCT03483051 PULSE-AS results posted 828994 Ph 2 completed Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS)
NCT01074918 012007-080 Ph 1, Ph 2 withdrawn Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients
NCT01818583 AK-01 Ph 4 completed Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
NCT01085071 GRIP-COMPASS GRIP-COMPASS trial Ph 4 completed Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

POTASSIUM CHLORIDE IN PLASTIC CONTAINER FDA Label Details

Indications & Usage

POTASSIUM CHLORIDE IN PLASTIC CONTAINER is indicated for the treatment of Hypokalemia; Metabolic Alkalosis.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.