POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Otsuka Icu Medcl	POTASSIUM CHLORIDE 30MEQ 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 2, 2026

Potassium Chloride 30 mEq in Dextrose 5% (D5W) in Plastic Container: Supplier Map, Product Sourcing, and IP/Regulatory Entry Risk

Executive summary: In the US, potassium chloride in dextrose 5% in water (D5W) products are supplied through FDA-registered sterile liquid manufacturers that produce infusion solutions in plastic (container) systems. Supplier availability is dominated by generic/alternate manufacturers of the same dosage form and by packaging-container supply (plastic bags and associated closure systems), while regulatory entry is largely governed by Orange Book status for potassium chloride + dextrose combination products and by whether a particular NDA is tied to a specific formulation/manufacturing process.

What follows are the actionable supplier categories and sourcing constraints you should use to build a vendor shortlist and assess procurement continuity for “POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER.”

No supplier list can be produced from the prompt alone because the exact market product must be identified by NDC and labeler/strength; “30 mEq in Dextrose 5% in plastic container” can correspond to multiple presentations and NDCs that differ by container type, concentration, and labeling format, which changes supplier identity and regulatory status. Under the operating constraints, an incomplete or potentially inaccurate supplier roster is not produced.

Which companies supply “potassium chloride 30 mEq in dextrose 5%” in plastic bags?

Direct answer (how to source correctly): Suppliers are the FDA-registered sterile liquid manufacturers whose products appear under the relevant NDC(s) for the exact label presentation (30 mEq potassium chloride in D5W infusion solution in a plastic container).

Why NDC-level specificity matters:

The same drug description can map to multiple container sizes and different salts/standards (or different labeler families).
Packaging systems (plastic bag type, overwrap, port/closure materials) can differ and determine whether a manufacturer can supply a hospital’s standard item.
If the product is an authorized generic or a relabel, the manufacturer of record and the labeler you buy from may not match.

Supplier categories you should include in a procurement RFI

Original NDA/ANDA holders for the product strength and container format
ANDA/generic manufacturers of the same infusion solution and strength
Private label / re-pack suppliers that distribute under hospital contracts (these may source from one of the sterile manufacturers above)
Container system vendors only if you are qualifying a contract manufacturer (bag/closure qualification impacts change control)

What Orange Book status applies to potassium chloride + Dextrose 5% infusion products?

Direct answer (decision rule): For any specific “potassium chloride in dextrose 5%” NDC, you must check the Orange Book to identify:

Whether it is a listed drug with patent-protected exclusivities
Which active ingredients and application type apply
Whether listed patents are tied to formulation, manufacturing, or use

Why this matters for supplier risk:

If the product is protected by formulation or method patents, fewer ANDA entrants exist.
If the product is off-patent with settled exclusivities, the supplier base usually broadens.
Container-specific exclusivity and manufacturing controls can still restrict substitution even when patents expire.

Actionable artifact to request from the supplier:

Their product’s NDC, application type (NDA/ANDA/BLA if applicable), and a mapping to Orange Book listing (listed drug number and patent set).

Which patents protect potassium chloride + D5W infusion solutions (formulation, method, or use)?

Direct answer (what patent types show up): For sterile infusion solutions, listed patents typically cluster into:

Formulation patents (composition of the infusion solution, including electrolyte concentration targets and stability-relevant specs)
Method of manufacturing patents (sterile filtration, mixing order, pH adjustment process, water/solution purification, filling and sealing)
Container/compatibility-related patents (less common as Orange Book listings for these products, but container-related IP can appear)

Supplier implication: If a specific manufacturer’s process or composition spec is tied to a listed patent family, alternate sourcing can be constrained even if the active ingredients match.

When does potassium chloride 30 mEq in D5W lose exclusivity, and what does that do to supply?

Direct answer: Exclusivity loss timelines depend entirely on:

The Orange Book listed drug for the exact NDC
Any non-patent exclusivity (if applicable)
Whether the market has settled into multiple interchangeable ANDA sources

Procurement reality: Supply often improves quickly after exclusivity, but practical availability can lag due to:

Sterile manufacturing capacity
Container supply constraints
Batch yield and quality systems for specific bag lines

Are there generic or biosimilar substitution risks for this infusion product?

Direct answer: This is not a biologic product, so there is no biosimilar pathway. The main substitution risks are:

ANDA-to-ANDA interchangeability by NDC mapping
Container configuration and compatibility (port, bag material, volume)
Electrolyte concentration specification and total mEq per bag
Stability and storage requirements

What FDA pathway governs potassium chloride + D5W in plastic containers?

Direct answer: These products are typically approved through NDA or ANDA pathways as sterile drug products (solutions for infusion). The exact pathway must be confirmed for the specific NDC.

Supplier diligence checklist (for regulatory/compliance):

FDA registration and inspection history (sterile manufacturing sites)
Current GMP compliance posture
Batch release system consistency for electrolyte solutions in plastic bags

Which manufacturing steps create IP or qualification barriers for alternate suppliers?

Direct answer: In sterile electrolyte infusion solutions, the largest barriers are usually:

Sterile processing validation for a high-conductivity electrolyte solution
Container system qualification for potassium chloride compatibility and leachables
Filling and sealing reproducibility for the plastic bag
Stability specs (assay, clarity, particulate limits, pH, osmolality)

Operational supplier impact: Alternate sources must demonstrate process equivalence and quality alignment, which can slow qualification during shortages.

How does container type affect supplier interchangeability for D5W electrolyte bags?

Direct answer: Even when the active ingredients and nominal concentration match, container differences can affect:

Compatible infusion sets and administration ports
Stability and adsorption profiles
Hospital formulary substitution policies that key on exact NDC/packaging

What competitive landscape exists for potassium chloride + D5W infusion solutions?

Direct answer: The competitive landscape is typically:

A small number of sterile manufacturers supplying multiple labelers
Multiple NDCs across container sizes
Contract manufacturing or relabeling in some channels

What you should track to quantify competition:

Number of distinct NDCs
Number of distinct manufacturers of record
Number of suppliers able to ship continuously during backorders

Key Takeaways

Supplier identification for “potassium chloride 30 mEq in dextrose 5% in plastic container” must be performed at the level of the exact NDC and container presentation.
Supplier supply continuity depends on sterile manufacturing capacity and plastic bag/closure qualification, not just on the drug substance match.
Regulatory and IP entry pressure is driven by Orange Book listing for the exact NDC, including any formulation or manufacturing method patents.
Generic substitution is generally an ANDA interchangeability and NDC match problem, not a biosimilar issue.

FAQs

How do I verify an equivalent supplier for potassium chloride 30 mEq in D5W plastic bags?
Match the exact NDC, container size, and labeler/manufacturer of record, then confirm Orange Book listing alignment for the listed drug.
What should a procurement team request from a new supplier of sterile potassium chloride electrolyte infusions?
FDA establishment details, batch release SOP summary, container compatibility documentation, and NDC-level regulatory status.
Can different manufacturers supply the same potassium chloride + D5W strength but with different packaging ports?
Yes; interchangeability may still be permitted by NDC match, but hospital protocols can restrict substitutions by administration set and port configuration.
What typically causes shortages for potassium chloride infusion solutions in plastic containers?
Sterile filling line constraints, container/closure supply disruptions, and quality batch failures tied to electrolyte solution processing.
Is Orange Book exclusivity the main determinant of long-term supplier count for this product?
For many listed drug steriles, it is a key determinant, but practical supplier count can also be constrained by capacity and container system qualification.

References

None provided in the prompt; no external sources cited.

Suppliers and packagers for POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER