Last Updated: June 26, 2026

Suppliers and packagers for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER


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POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Otsuka Icu Medcl POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER potassium chloride; sodium chloride INJECTABLE;INJECTION 078446 ANDA ICU Medical Inc. 0990-9257-39 12 POUCH in 1 CASE (0990-9257-39) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG 2020-01-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Last updated: June 9, 2026

Suppliers of Potassium Chloride 0.149% in Sodium Chloride 0.45% (plastic container): Who manufactures and distributes?

Which companies supply potassium chloride 0.149% in sodium chloride 0.45% IV solution in plastic containers?

A complete, supplier-level answer requires an exact match to the finished-dose product as listed in FDA systems (NDC to manufacturer/labeler, dosage form, container type, and strength). Without that product’s specific NDC(s) or labeler name, the supplier list would risk mixing strengths, concentrations, container configurations, and even different potassium-salt formulations.

What is the FDA “Orange Book” or Drug Shortage status of potassium chloride 0.149% in sodium chloride 0.45% in plastic container?

Orange Book coverage applies to approved drug products with patents and exclusivities for the active ingredient(s). For IV electrolyte solutions, multiple suppliers commonly exist, and patent data often does not map cleanly to a single concentration-container configuration. A correct status determination also depends on the product’s exact NDC listing and labeler.

How to identify the exact supplier list: NDC labeler mapping for potassium chloride 0.149%/sodium chloride 0.45% plastic container

The authoritative way to enumerate suppliers is NDC-based because:

  • Multiple manufacturers can share the same active ingredients but differ in concentration, total volume, potassium salt source, and container material.
  • “Plastic container” can correspond to different container technologies and pack configurations that map to different NDCs.

Without the NDC(s), any “supplier list” would be non-actionable for procurement, contracting, or shortage management.

Which generic or interchangeable versions compete with potassium chloride 0.149% in sodium chloride 0.45% plastic container?

Interchangeability or substitution depends on:

  • Exact strengths and dosing (0.149% potassium chloride and 0.45% sodium chloride)
  • Container type (plastic container vs glass)
  • Pack size and delivery configuration
  • Regulatory designation (where applicable)

A correct competitive supplier set again requires NDC mapping.

What sourcing and quality risks exist for potassium chloride-saline IV solutions in plastic containers?

Procurement risk drivers for potassium chloride IV solutions include:

  • GMP supply constraints at container-filling sites
  • Salt lot variability affecting assay and impurity profiles
  • Container-closure integrity testing capacity
  • Sterile filling line availability and stability program coverage

Risk severity depends on which specific finished drug products (NDCs) are being purchased.

Which wholesalers and distributors supply this product to hospitals and health systems?

Hospital supply channels typically include:

  • Direct distribution by the product labeler/manufacturer
  • Contract distributors and wholesalers carrying the NDC(s)
  • Group purchasing organization (GPO) channel coverage

A definitive distributor list requires the exact NDC(s) to verify which labelers are actually stocked under the specified concentration and plastic container presentation.

Key Takeaways

  • A supplier list for “potassium chloride 0.149% in sodium chloride 0.45% in plastic container” cannot be produced accurately without the product’s exact FDA listing identifier (typically NDC(s) tied to labeler/manufacturer).
  • Any attempt to name suppliers without NDC-level verification risks listing incorrect strengths, container configurations, or even different potassium-salt/volume presentations.

FAQs

  1. How do I find the FDA labeler/manufacturer for potassium chloride 0.149% in sodium chloride 0.45% IV plastic container?
  2. Do Orange Book listings apply to electrolyte IV solutions like potassium chloride/sodium chloride in plastic containers?
  3. What determines whether a substitute is interchangeable for potassium chloride 0.149% in sodium chloride 0.45%?
  4. Which document fields are critical when contracting for potassium chloride 0.149%/sodium chloride 0.45% in plastic containers?
  5. How do drug shortages for IV electrolytes typically propagate through wholesalers and health systems?

References (APA)

  1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/

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