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Suppliers and packagers for POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
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POTASSIUM CHLORIDE 0.075% 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 |
|---|---|---|---|---|---|---|---|---|---|
| B Braun | POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER | dextrose; potassium chloride | INJECTABLE;INJECTION | 019699 | NDA | B. Braun Medical Inc. | 0264-7625-00 | 12 CONTAINER in 1 CASE (0264-7625-00) / 1000 mL in 1 CONTAINER | 1989-09-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Potassium Chloride 0.075% in Dextrose 5% (Plastic Container): Manufacturing, Contract, and Distribution Landscape
Potassium chloride 0.075% in dextrose 5% (commonly supplied as an IV admixture in plastic containers) is distributed through GPO-aligned hospital supply chains and shipped by major sterile-drug manufacturers and contract packagers. The supplier set is highly container- and concentration-specific, and the authorized commercial source list is typically governed by FDA drug product authorization (NDC), state wholesaler licensing, and GPO contract awards rather than by a single universal “list of suppliers.”
Who supplies potassium chloride 0.075% in dextrose 5% in plastic containers to hospitals?
Featured snippet answer: Suppliers are the manufacturers and repackagers that hold the specific NDC(s) for “potassium chloride in dextrose 5%” IV solutions and the distribution intermediaries (wholesalers and specialty distributors) that service hospital purchasing under GPO contracts.
How supply is usually structured
- Sterile drug manufacturer / labeler (NDC holder): Produces or contracts sterile compounding, then holds the FDA-labeled product authorization for the specific concentration and container type.
- Contract packager / sterile logistics partner (when applicable): Supplies pre-filled plastic container product or performs sterile filling and labeling.
- Wholesaler / distributor: Moves product into health systems, often under GPO agreements.
- Hospital pharmacy compounding (where permitted): Some sites produce potassium chloride in D5W from bulk components, but that is not a “supplier” in the same sense as an NDC-labeled product.
Common procurement channels
- GPO contracts: Hospital systems typically buy through GPO-negotiated pricing, with one or more preferred wholesalers.
- Authorized distributors: Repackagers and distributors with active sourcing agreements with NDC holders.
- Direct supply from manufacturers: Some suppliers ship directly to large systems with negotiated terms.
Which companies manufacture potassium chloride in Dextrose 5% IV solutions for plastic containers?
Answer frame: The “right” manufacturers are those that list the matching NDCs for the exact formulation strength (potassium chloride 0.075% in dextrose 5%) in a plastic container. In practice, the market is dominated by companies that have large sterile product platforms, including IV solution and electrolyte portfolios.
Typical manufacturer profiles in this category
- Sterile IV solution manufacturers with electrolyte lines
- Companies with PLASTIC-CONTAINER IV admixture capabilities
- Firms with established hospital distribution networks
NDC-specific reality check
The supplier list cannot be reliably enumerated without an NDC-to-product mapping for:
- exact strength (0.075% potassium chloride)
- diluent concentration (dextrose 5%)
- container type (plastic container)
- package size and presentation
Without those identifiers, any named supplier list would risk conflating:
- different potassium concentrations (e.g., 0.15% or other strengths)
- different diluents (D5W vs other dextrose strengths)
- different container formats (glass vs different plastic systems)
- differently labeled products with the same active ingredients but different concentration
What NDC holders supply potassium chloride 0.075% in dextrose 5% in plastic containers?
Featured snippet answer: NDC holders are the FDA-listed labelers that market the specific product strength and container type. This is the authoritative way to identify suppliers. The exact NDC holder list is determined by FDA’s product database and is a prerequisite for a precise supplier roster.
Why NDC holder matters
- It drives FDA product authorization and substitution at the pharmacy and wholesaler level.
- It determines patent and exclusivity constraints for the specific labeled product.
- It ties to supply availability during shortages.
What wholesaler distributors supply this IV formulation into hospital systems?
Answer frame: Even when multiple labelers exist, hospital availability depends on which wholesalers carry the NDCs under contract and which products are in distributor inventory.
Where distributors typically appear in the chain
- Large national wholesalers provide broad hospital coverage.
- Specialty distributors may cover intermittent allocation when supplies tighten.
- Smaller regional distributors fill gaps for particular container formats or package sizes.
Which contract packagers can supply potassium chloride 0.075% in dextrose 5% in plastic containers?
Featured snippet answer: Contract packagers supply the product only if they are tied to the labeler’s specific sterile filling and packaging configuration for that exact formulation and container.
Contracting drivers
- Allocation and manufacturing slot constraints during shortages
- Regional capacity for plastic-container filling
- Regulatory approval status for that specific strength and presentation
How do shortages affect the supplier list for potassium chloride in D5W?
Featured snippet answer: During shortages, hospitals often see increased substitution between NDC holders and, less commonly, substitution to alternate strengths or container configurations if clinically acceptable and permitted by policy.
Supplier-switch mechanisms
- Switching between NDC holders of the same formulation strength
- Short-term import or alternative manufacturing site (within the same labeler, different facility)
- Rebalancing of wholesaler allocations and prioritization to contracted health systems
What formulations are typically substituted when potassium chloride 0.075% in D5W is unavailable?
Answer frame: Substitutions usually remain within the same therapeutic class (electrolyte supplementation) but change concentration or container configuration. The most common substitution paths are:
- different potassium chloride percentage in D5W (higher or lower KCl concentration)
- different dextrose concentration (D5W vs D10W or other)
- different container system (if institution-level substitution is permitted)
A precise substitution map also requires the institution’s therapeutic interchange rules and the NDC-level labeling constraints.
Regulatory and compliance: how suppliers prove they can sell this plastic-container IV product
Featured snippet answer: Suppliers must market the specific FDA-labeled product (NDC) and stay compliant with sterile manufacturing and distribution regulations, including DSCSA for traceability.
What compliance affects in practice
- Cold-chain is usually not a driver for D5W electrolyte admixtures, but sterile integrity and packaging integrity are.
- Temperature excursions, seal integrity, and shipment conditions affect product lot acceptance in hospital receiving.
- DSCSA traceability dictates which wholesaler lots can be traced and resold in the supply chain.
Key Takeaways
- The supplier list for potassium chloride 0.075% in dextrose 5% in plastic containers is fundamentally NDC-holder driven, not generic ingredient driven.
- Hospitals buy through GPO contracts and distributor inventory, so “supplier availability” depends on the labeler’s distribution footprint as well as manufacturing uptime.
- Any accurate supplier roster must be anchored to the exact NDC(s) for the formulation strength and plastic container presentation.
FAQs
-
How do I identify the correct supplier for “potassium chloride 0.075% in dextrose 5%” without confusion with other KCl strengths?
Match the specific NDC and package size to the labeled formulation strength and plastic container. -
Can I substitute another potassium chloride concentration in D5W if 0.075% is out of stock?
Substitution depends on institutional policy, prescriber direction, and clinical compatibility; it is typically handled via the formulation options available under the same therapeutic intent. -
Do wholesaler distributors change from facility to facility for this IV product?
Yes. Distributors vary by GPO contract coverage and local inventory management. -
Are there contract packagers for this product, or is it only made by large manufacturers?
Both models exist, but contract packaging is only relevant when tied to the labeler’s FDA-authorized NDC for this exact strength and container. -
How can DSCSA affect availability for hospital receiving of KCl in D5W?
It affects traceability and lot-level authorization, which can delay or block receiving if documentation does not align with traceability requirements.
References
- U.S. Food and Drug Administration. Orange Book and product databases (labeler/NDC-driven product authorization). APA: FDA.
- FDA DSCSA guidance and traceability frameworks. APA: U.S. Food and Drug Administration.
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