Suppliers and packagers for POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% 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 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	dextrose; potassium chloride	INJECTABLE;INJECTION	018371	NDA	ICU Medical Inc.	0990-7905-09	12 POUCH in 1 CASE (0990-7905-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG	2020-11-20

Suppliers and packagers for POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER

Last updated: May 31, 2026

Potassium Chloride 40 mEq in Dextrose 5% in Plastic Container: What suppliers provide this IV drug and how to qualify sources

Who supplies potassium chloride 40 mEq in dextrose 5% IV (plastic container)

This product is commonly sourced through large US sterile injectable manufacturers and authorized contract packagers that produce potassium chloride in D5W as IV admixture/combination products or as a premix depending on labeling and container configuration. Supplier lists are typically constrained to what appears on the FDA’s Drug Shortages postings, the Orange Book if a listed NDA exists, and the actual NDC labeler/manufacturer on distributor listings for the exact strength and container (plastic).

In practice, purchasing and qualification is executed at three levels:

1. Labeler/NDA holder for the exact NDC (the company responsible for the marketed product).
2. Sterile manufacturing site (often disclosed on labeling and BLA/NDA establishment databases).
3. Secondary suppliers (distributors and wholesalers) that hold inventory for fulfillment.

Actionable procurement approach: treat “40 mEq potassium chloride in D5W in plastic container” as an NDC-specific SKU and qualify sources by NDC labeler + manufacturer code + container type + package size.

Which manufacturers make potassium chloride in dextrose 5% IV solutions in plastic containers

Potassium chloride IV products in D5W are typically produced by:

• Large sterile injectable manufacturers with potassium chloride lines and D5W premix capability
• Admixture plants that prepare “components plus dextrose base” into sterile containers under validated aseptic processes

Because your request specifies a specific combination strength and container type, the only defensible “supplier” list is the set of companies tied to the exact NDC. Without the NDC (or labeler/manufacturer code) for your exact SKU, any supplier list would be incomplete or potentially wrong.

What are the most common supplier categories for this IV potassium chloride product

For procurement and continuity of supply, suppliers fall into these buckets:

Premix manufacturers (commercial sterile product)

• Sell a packaged, sterile combination product with defined strength and container configuration.
• Lower variability risk versus admixture if you standardize on the same NDC.

Aseptic admixture manufacturers (prepared to order or in batches)

• Prepare sterile infusions using validated processes.
• Supplier diversity is often broader during shortages but documentation requirements are heavier (lot traceability, endotoxin, sterility, particulate testing, and COA linkage).

Distributors and wholesalers

• Source from upstream labelers and allocate inventory.
• Useful for short-term continuity but do not replace upstream GMP risk assessments.

What NDC-specific data should be used to identify eligible suppliers

Supplier qualification for this exact drug should be pinned to these fields from label/COA:

• NDC (11 or 10 digit) for the exact strength and presentation
• Labeler name (NDC labeler)
• Manufacturer name/code (from the NDC directory)
• Package size (e.g., single container vs multipack)
• Container type (plastic container format, including bag vs vial)
• Storage conditions and expiration dating requirements
• Sterility assurance level documentation and release specs on COA

How do you qualify alternative suppliers for potassium chloride 40 mEq in D5W

For a sterile IV potassium chloride admixture/premix, supplier qualification typically requires:

• GMP and quality system audit (or reliance on existing audits)
• Review of:
  • Sterility assurance package
  • Endotoxin limits and test methodology
  • Particulate matter controls
  • Container closure integrity data
  • Stability program for potassium chloride in D5W in plastic packaging
• Lot-level review process and inbound QC plan
• Compatibility confirmation for your site’s clinical use (administration set materials, line compatibility, infusion rates)

When do shortages change supplier availability for this potassium chloride IV product

Supplier availability for IV potassium chloride in D5W can change quickly due to:

• Sterile manufacturing capacity constraints
• Raw material supply variability (potassium chloride and D5W base)
• Sterility testing throughput
• Container supply constraints (plastic bag component availability)

In shortage periods, procurement often shifts from:

• Premix labelers to
• Admixture providers and multi-source distributor supply.

What licensing or substitution rules apply when switching suppliers

Switching suppliers for the same NDC is typically treated as:

• Same drug product if NDC and presentation match exactly
• Different drug product if container, concentration, or packaging configuration differs even if the active ingredients match

For US supply chain, substitution decisions generally track:

• The FDA NDC directory listing and label configuration
• Your facility’s pharmacy policy and state substitution rules
• Whether your product is treated as a commercial NDC vs compounded/prepared supply

Key takeaways

• “Potassium chloride 40 mEq in dextrose 5% in plastic container” is NDC-specific for supplier identification.
• The only reliable supplier list comes from the exact NDC labeler/manufacturer and presentation tied to your SKU.
• In practice, sources fall into premix manufacturers, aseptic admixture plants, and distributors, with different qualification and risk profiles.
• During shortages, supply often shifts toward aseptic admixture and alternate distributor inventory, but only if the NDC/presentation match your clinical and packaging requirements.

FAQs

1) What documentation do hospitals need to switch suppliers for IV potassium chloride in D5W?

COA per lot, sterility/endotoxin confirmation, stability/expiration confirmation for that container configuration, and traceability linking the supplied lot to the labeler manufacturing batch.

2) Is “potassium chloride 40 mEq in D5W” interchangeable across different container types?

No. Compatibility, labeling, and NDC presentation can differ by container format. Substitution should be controlled by matching the exact NDC and presentation.

3) Can I source this product through a distributor during shortages?

Yes, but distributors must be treated as logistics providers. Your quality qualification still depends on the upstream labeler/manufacturer lot documentation and NDC match.

4) What are the main quality risks when using alternate manufacturers for sterile IV potassium chloride?

Sterility assurance consistency, endotoxin controls, particulate control, container closure integrity, stability in plastic, and correct labeling of concentration and total mEq delivered.

5) How do I confirm the supplier for my exact presentation?

Match the NDC from your order packaging/label to the NDC directory listing and use the labeler/manufacturer identity and manufacturing site data from that listing for qualification.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. National Drug Code (NDC) Directory. FDA.
3. U.S. Food and Drug Administration. Drug Shortages. FDA.