TheraRadar
Data updated: May 26, 2026

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% (potassium chloride)

Other Approved 1979-02-02

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% is indicated for the treatment of Hypokalemia; Metabolic Alkalosis.

Source: FDA Label • Baxter

How POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% Works

Potassium is the principal intracellular cation, essential for maintaining intracellular tonicity and the electrochemical gradient across cell membranes via the Na+/K+-ATPase pump. It is a critical cofactor in numerous physiological processes, including the transmission of nerve impulses, the contraction of cardiac, skeletal, and smooth muscle, and the maintenance of normal renal function. By providing exogenous potassium, this medication restores the necessary concentration gradient required for proper cellular depolarization and repolarization.

2
Indications
--
Phase 3 Trials
47
Years on Market

Details

Status
Prescription
First Approved
1979-02-02
Routes
INJECTION
Dosage Forms
INJECTABLE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% Approval History

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Original
New Indication
New Form
Label Update
54 FDA actions from 1979 to 2020
Sep 2020 ORIGINAL
Update
Jan 2019 SUPPL
Label · Labeling
Nov 2016 SUPPL
Mfg · Manufacturing (CMC)

What POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% Treats

2 indications

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% is approved for 2 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypokalemia
  • Metabolic Alkalosis
Source: FDA Label

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% Competitive Set

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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NCT04316611 POTACREH APHP180577 2019-002544-24 Ph 2 withdrawn Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation
NCT02450773 201501157 Ph 2 withdrawn Prevention of Severe Postpartum Hypertension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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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 0.15% IN SODIUM CHLORIDE 0.9% FDA Label Details

Indications & Usage

FDA Label (PDF)

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 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.