TheraRadar
Data updated: May 26, 2026

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

Other Approved 1989-09-29

This intravenous medication is indicated as a source of water and electrolytes for the prevention and treatment of potassium deficiency (hypokalemia) when oral replacement is not feasible or is inadequate. It serves as an electrolyte replenisher, providing potassium, sodium, and chloride to maintain or restore fluid and electrolyte balance.

Source: FDA Label • B BRAUN

How POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Works

This drug works by providing potassium ions, which are the principal intracellular cations of most body tissues. These ions are essential for maintaining intracellular tonicity, transmitting nerve impulses, contracting cardiac, skeletal, and smooth muscle, and maintaining normal renal function. The solution also provides sodium and chloride ions, which are the primary electrolytes of the extracellular fluid, helping to maintain osmotic pressure and acid-base balance.

1
Indication
--
Phase 3 Trials
36
Years on Market

Details

Status
Prescription
First Approved
1989-09-29
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: POTASSIUM CHLORIDE , SODIUM CHLORIDE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Approval History

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Original
New Indication
New Form
Label Update
15 FDA actions from 1989 to 2026
Jan 2026 SUPPL
Label · Labeling
Aug 2014 SUPPL
Mfg · Manufacturing (CMC)
Aug 2005 SUPPL
Label · Labeling

What POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Treats

2 indications

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 1989. 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% 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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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% IN PLASTIC CONTAINER FDA Label Details

Indications & Usage

FDA Label (PDF)

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 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.