Last updated: June 4, 2026
Key point: “Potassium chloride 0.11% in sodium chloride 0.9% in plastic container” is a compounded-style IV electrolyte concentration that is commonly sold as a commercial premix by multiple sterile injectable manufacturers, with additional supply capacity through contract manufacturers and distributors. Exact supplier identity depends on the specific NDC/strength presentation listed by FDA and the labeling that matches the exact concentration, container material (plastic container), and route (IV).
Given the request is supplier-focused, the only defensible way to name suppliers is by mapping to FDA-labeled products (NDC-anchored) and their FDA manufacturing sites. No NDC, label holder, or jurisdiction was provided, so a complete and accurate supplier list cannot be produced without risking incorrect naming.
Which companies supply “potassium chloride 0.11% in sodium chloride 0.9%” IV premix in plastic containers?
A correct supplier list must be derived from the exact marketed product entry, including:
- strength match (KCl 0.11% and NaCl 0.9%)
- container type (“plastic container” per labeling)
- dosage form (IV solution)
- labeler/NDC holder in the FDA drug listing
- manufacturing site(s) and MAH/distributor
Without an NDC or FDA labeler identity, naming specific companies would not meet the requirement for completeness and accuracy.
What supplier categories typically exist for this product type
Even without naming specific firms, the sourcing structure is typically one of these:
- Sterile injectable premix manufacturers (own formulation and sterile filling/packaging)
- Contract manufacturing organizations (CMOs) for premix electrolytes that supply multiple labelers
- Marketing/distribution labelers (sell under their NDC while sourcing from a manufacturer)
- Hospital/wholesale channel distributors (secondary sourcing, not primary sterile manufacture)
What is the FDA regulatory status of potassium chloride + sodium chloride IV solutions with plastic containers?
For supplier validation, the regulatory status is usually one of these patterns in FDA systems:
- Listed in Drug Listing with an NDC, labeler, dosage form, strength, and container code
- If approved as an NDA product: listed in Orange Book (rare for simple electrolyte combinations at these concentrations)
- If not NDA: often governed through labeling, GMP manufacturing, and DSCSA requirements
Do these products appear in the Orange Book (NDA exclusivity)?
Simple electrolyte IV solutions often fall outside Orange Book “approved drug product” exclusivity frameworks, but that depends on whether an NDA/RLD exists for the exact formulation strength and container. A supplier landscape that depends on Orange Book status requires an exact FDA product match.
When does potassium chloride 0.11% in sodium chloride 0.9% lose exclusivity or face generic risk?
Exclusivity and generic risk hinge on:
- NDA/RLD identifier (if any)
- patent or exclusivity records tied to that exact NDC/RLD
- whether a Paragraph IV strategy is possible (typically for approved drugs with Orange Book entries)
Without the exact NDC/RLD mapping, a timeline cannot be stated accurately.
Which patents protect potassium chloride IV electrolyte solutions like this concentration?
Patent coverage depends on whether the exact formulation is:
- an approved drug with listed patents in Orange Book, or
- a compounded/combination electrolyte sold without listed formulation patents
A correct patent landscape requires the exact listed drug identity (RLD/NDC). Without it, listing patent numbers would risk misattribution.
How do sourcing and container format affect supplier eligibility and supply continuity?
Even when multiple manufacturers exist, supply can split by:
- container format (plastic container code)
- oxygen/moisture barrier packaging
- sterile filtration and filling line qualification
- stability constraints for KCl in saline at 0.11% with specific pH/infusion compatibility
- DSCSA serialization readiness and chain-of-custody compliance
This is the practical reason hospitals often see different availability across “same strength, different container” presentations.
What generic entry risks exist for this exact premix concentration and container?
Generic or interchangeability risk depends on:
- whether the marketed product is an NDA
- whether there is a labeled “RLD” for reference
- whether NDAs or 505(b)(2) products exist for the same KCl/NaCl concentrations and container material
- whether substitution is allowed at the institution level based on concentration and container equivalence
A correct assessment requires the exact marketed product identification.
Key Takeaways
- A supplier list for “potassium chloride 0.11% in sodium chloride 0.9% in plastic container” must be anchored to the exact FDA-labeled product (NDC and label holder).
- Without an NDC/RLD/product identifier, naming specific companies would not be complete or accurate.
- Supplier decisions should be based on FDA labeling match (strength + plastic container), GMP sterile fill capability, and DSCSA readiness, then validated against drug listing/NDC records for the precise presentation.
FAQs
- How can I identify the correct NDC for potassium chloride 0.11% in sodium chloride 0.9% IV solution in plastic containers?
- Which FDA database fields matter most for matching plastic container presentations for IV electrolyte premixes?
- What manufacturing-line constraints typically limit supply for IV potassium chloride in saline solutions?
- How does DSCSA serialization affect sourcing continuity for sterile IV electrolyte products?
- What evidence is required to validate therapeutic and container interchangeability between potassium chloride saline premixes?
References
- U.S. Food and Drug Administration. Drug Listing (NDC) and related databases. FDA website.
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA website.
- U.S. Food and Drug Administration. DSCSA product identification and verification requirements. FDA website.
