DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K): Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	018037	NDA	Baxter Healthcare Company	0338-0663-04	1000 mL in 1 BAG (0338-0663-04)	1979-02-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 2, 2026

Suppliers for Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 15 mEq (K) IV: Who Manufactures and Who Can Supply in the US and EU

Executive summary: The product is an IV electrolyte-dextrose combination (commonly used as “D5NS + K” or similar potassium-added dextrose/saline admixture configurations). In practice, supply comes from (1) contract manufacturers producing sterile small-volume or large-volume bags under label, (2) pharma wholesalers/distributors stocking branded/authorized generics, and (3) hospital/IDN compounding under pharmacy-prepared admixture workflows when an exact premix is not commercially available. Exact “premix name + strength” suppliers vary by market and label, and the cleanest supplier identification is driven by the FDA label/NDC or EU marketing authorization holder (MAH) for the specific concentration set (Dextrose 5% w/v, NaCl 0.2% w/v, KCl 15 mEq/L).

What you can operationalize now: If you need a supplier list for procurement, the actionable method is to anchor on the authorized listing (NDC in the US; MA/marketing authorization in the EU) and then map to: (a) MAH/labeler, (b) manufacturing site(s) and CMO/sterile fill-finish vendors, and (c) distributors that carry it. Without the exact NDC or EU MA number tied to your target pack size, the universe of “suppliers” cannot be listed accurately to be litigation-usable for sourcing, audits, or contingency planning.

Which companies supply dextrose 5%, sodium chloride 0.2%, and potassium chloride 15 mEq (K) IV in the US?

Featured snippet answer: In the US, supply is typically split between (1) the company listed as the labeler/marketing authorization holder on the product’s FDA registration/NDC listing and (2) authorized distributors (McKesson, Cardinal Health, AmerisourceBergen, and regional wholesalers) that stock that NDC. For many potassium-containing dextrose/saline admixture strengths, hospitals also use compounding pharmacies to prepare an exact concentration mix when a premixed sterile product is unavailable or backordered.

How to identify the true premix supplier (labeler vs manufacturer)

Labeler/MAH (procurement-facing supplier): the entity that owns the NDC label and is responsible for product release and labeling compliance.
Manufacturer/CMO (supply-chain-facing): the sterile manufacturing site and fill-finish contractor(s) listed on FDA product registration and, when available, the drug establishment inspection program (FDA EIR) entry for the site.
Distributor network: wholesaler catalog availability is NDC-specific. Procurement allocation and substitution control is also NDC-specific.

US procurement reality for potassium-added dextrose/saline

If the exact premix is not consistently marketed, supply often shifts to:
1. Alternative premix strengths (different NaCl percent or different potassium concentration), or
2. Compounded equivalents (pharmacy admixture under state licensure, hospital protocols, and sterile compounding standards).

What patents cover Dextrose 5% / NaCl 0.2% / KCl 15 mEq IV?

Featured snippet answer: This is an aqueous electrolyte-dextrose composition that is commonly treated as a low-innovation sterile solution where composition patents are often absent or already expired, and IP protection, when present, typically centers on packaging, manufacturing process, or specific concentration ranges/sterility-assurance methods for a particular labeled product. Patent coverage is usually not the gating factor for supply compared with manufacturing capacity, sterile fill-finish constraints, and regulatory batch release.

Where IP can still matter for supply

Sterile manufacturing process patents for specific fill volumes, bag materials, or aseptic processing conditions.
Stability and shelf-life improvements for particular container-closure systems (PVC-free bags, multi-layer films, oxygen scavenging, etc.).
Method-of-manufacture claims held by sterile CMOs for particular formulations.

What is the Orange Book status for this potassium-containing dextrose-saline IV?

Featured snippet answer: Whether the product appears in the FDA Orange Book depends on whether it is marketed as a drug with listed patents tied to an approved NDA/ANDA and whether those patents are still active. Many electrolyte IV solutions are not listed in the Orange Book with active exclusivity because there are no patent estates tied to an application.

How to check status in practice

Confirm the exact product via NDC.
Query Orange Book listing for the matching active ingredient(s) and strength.
Map listed patents and expiration dates to assess exclusivity and patent barriers.

Which suppliers can provide sterile IV bags for these exact concentrations (process and compliance)?

Featured snippet answer: The suppliers that can credibly provide this product at scale are the ones with:

sterile aseptic capability for aqueous electrolyte solutions
validated compounding/fill lines for bag sizes used by the label
controlled moisture/COA-based release for dextrose, NaCl, and KCl
quality systems aligned with CGMP and USP <797>/<<800> expectations for sterile products (for hospital compounding equivalents)

Primary supply-chain categories

Sterile contract manufacturers (CMOs): fill-finish and packaging for IV solutions
Packagers/bag suppliers: supply primary packaging materials and may co-develop stability
Distributors/wholesalers: logistics and inventory management for the labeled NDC

What generic entry risks exist for dextrose/saline/potassium IV premixes?

Featured snippet answer: “Generic entry risk” is usually driven by manufacturing availability and regulatory standing (approved applications, batch release capacity, and site inspection outcomes) rather than exclusivity. If a premix is temporarily absent, substitution and compounding typically fill the gap.

Common constraint drivers

sterile fill-finish line downtime or sterility assurance failures
ingredient supply constraints (dextrose monohydrate, KCl, bag components)
delayed batch release due to sterility testing or analytical method verification

How does the supplier landscape differ between US wholesaler supply vs hospital compounding?

Featured snippet answer: US wholesaler supply is NDC-specific and follows allocated distribution during shortages; hospital compounding is recipe-specific and follows state licensure, facility capability, and stability beyond-use dating protocols.

Operational implications

If your requirement is exact Dextrose 5% / NaCl 0.2% / KCl 15 mEq, premix supply reduces variability.
If compounding is used, the practical differentiator becomes:
- ingredient grade and incoming COAs
- mixing order, final pH considerations
- container compatibility and assigned beyond-use dating

Which distributors typically stock electrolyte-dextrose IV products in bulk?

Featured snippet answer: Large national wholesalers usually list most mainstream IV solutions, but stocking for specific potassium-added strengths is inventory- and allocation-dependent.

US distributor tiers (typical channels)

National wholesalers (broad formulary coverage)
Regional wholesalers (faster local allocation in some markets)
Group purchasing organizations (GPO) contracted supplier networks
Hospital supply chain partners (IDN-managed sourcing)

What pack sizes and container-closure systems impact supplier availability?

Featured snippet answer: Supplier availability often tracks the container format:

bag size (for example, 500 mL, 1000 mL, 250 mL)
bag material (PVC vs non-PVC)
infusion set integration or stopper/port configuration

Why the container matters

stability and leachables
adsorption to bag films
compatibility with KCl and dextrose under intended shelf life

Timeline: When do these products typically go into or out of shortage?

Featured snippet answer: Shortage events for IV solutions are often linked to sterile manufacturing capacity and batch release delays. For procurement planning, you monitor FDA shortage alerts tied to the exact product listing (again, anchored by NDC).

Procurement planning framework

monitor shortage notices
prequalify substitution SKUs (near-concentration equivalents)
prequalify compounding partners if premix is unavailable

Key Takeaways

Supplier identification must be anchored to the exact authorized product listing (US: NDC; EU: MA/MAH) to produce a correct, procurement-grade supplier map.
Supply comes from the labeler/MAH plus sterile fill-finish/manufacturing sites, distributed through authorized wholesalers; hospitals may compound when premixes are unavailable.
IP is usually not the primary bottleneck for this electrolyte-dextrose combination; manufacturing capacity and sterility release are the dominant constraints.
Container size and bag material strongly influence whether a supplier can provide the exact configuration.

FAQs

How do I find the exact supplier for a specific potassium-added dextrose/saline IV strength? Use the product’s NDC (US) or MAH (EU) and map labeler to manufacturing site and distributor stocking.
Can hospitals substitute this premix with a compounded equivalent? Yes, under licensed sterile compounding workflows using validated recipes, but it introduces recipe variability and beyond-use dating constraints.
What typically causes shortages of IV dextrose/saline/potassium products? Aseptic manufacturing line capacity limits, analytical release delays, sterility assurance testing timelines, and ingredient or packaging component disruptions.
Do these electrolyte IV solutions have Orange Book-listed patents that block generics? Often no or limited; for many such solutions the practical risk is supply capacity rather than patent exclusivity.
Does bag material (PVC vs non-PVC) affect supplier eligibility? Yes, because compatibility, stability, and extractables/leachables profiles can limit which manufacturers can support the required shelf life.

References

FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
FDA Drug Shortages. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-shortages
FDA National Drug Code Directory. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory

Suppliers and packagers for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)