Suppliers and packagers for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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 30MEQ	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

Suppliers for Dextrose 5% + Sodium Chloride 0.2% + Potassium Chloride 30 mEq (IV Solution)

Last updated: April 25, 2026

What product specification are suppliers typically asked to meet?

The requested admixture is an IV solution containing:

• Dextrose: 5% w/v
• Sodium chloride: 0.2% w/v
• Potassium chloride: 30 mEq/L (commonly delivered as KCl; 30 mEq corresponds to a defined gram-per-liter basis depending on the salt form)

Because this is an admixture, “supplier” usually means one of two supply models:

1. Centralized hospital/national compounding (pharmacy-manufactured and distributed under local licensure/regulatory frameworks)
2. Contract manufacturing / sterile compounding vendors that produce ready-to-use admixtures or provide sterile starting components plus compounding services

Which supplier types can provide these specific admixtures?

1) Major sterile compounding and IV admixture contract manufacturers

These firms typically offer:

• Multi-dose and single-dose sterile production
• Admixture capability for common electrolytes and dextrose-based fluids
• Release testing, cold-chain handling, and batch traceability

Common examples in many markets (verify local distribution and formulation capability for the exact strengths requested):

• Baxter (sterile IV solutions and admixture capability in select programs)
• Hospira/Pfizer sterile portfolio (varies by market; admixture programs depend on contracting)
• Fresenius Kabi (IV solutions and infusion-related manufacturing; admixture programs vary)
• McKesson/Omnicell-affiliated sterile services in some regions (distribution and compounding models vary)

2) Third-party sterile compounding pharmacies (regional)

These suppliers typically serve hospitals and long-term care with:

• Customized admixture preparation
• Labeling and barcoding
• Controlled cold-chain shipping when required

3) Hospital in-house sterile compounding

Where supply contracts do not cover the exact admixture, hospitals compound from:

• Dextrose 5% injection
• Sodium chloride injection
• Potassium chloride injection concentrate under institutional sterile compounding SOPs.

What are the component suppliers most often used to build this admixture?

In practice, many purchasing workflows source the following sterile components, then compound to the target final concentrations:

Component in admixture	Typical sterile component form	Supplier categories that provide it
Dextrose 5%	Dextrose injection (5% w/v)	Major IV solution manufacturers and distributors
Sodium chloride 0.2%	Sodium chloride injection (strength selected to allow 0.2% final)	Major IV solution manufacturers and distributors
Potassium chloride 30 mEq/L	Potassium chloride injection concentrate (KCl)	Major injection manufacturers; specialty KCl concentrations vary

For purchasing accuracy, buyers typically confirm:

• Potency labeling (mEq/mL or gram/mL for KCl concentrate)
• Container/volume configuration (to hit exact mEq/L in the final bag)
• Compatibility (trace additive restrictions, plastic bag considerations)

How do suppliers price and package this item (what buyers should expect)?

Most supplier quotes fall into one of these structures:

• Per-bag contract price for pre-compounded sterile admixtures
• Per-component pricing when compounding is done in-house or by a regional pharmacy
• Volume tiers (hospital utilization drives unit pricing)

Packaging and labeling typically include:

• Bag size (common IV bag volumes: 100 mL, 250 mL, 500 mL, 1000 mL depending on institution)
• Sterile compounding label with final concentrations and total mEq of potassium
• Expiration dating based on compounding process and sterile control standards

What documentation suppliers should provide for procurement?

For sterile compounded IV admixtures, procurement usually requires:

• Batch/lot traceability
• Sterility assurance and release documentation
• End-product specifications (final concentrations: 5% dextrose, 0.2% sodium chloride, 30 mEq potassium)
• Handling/storage requirements (including temperature controls if required)

What are the regulatory and quality expectations that gate supplier selection?

Supplier approval typically depends on:

• Licensure for sterile compounding/manufacturing
• GMP or equivalent quality system controls for sterile production
• Documented stability and expiration assignment methods
• Sterile filtration/aseptic processing controls where applicable

Key Takeaways

• This admixture is typically supplied either as pre-compounded sterile product from contract sterile manufacturers/sterile compounding pharmacies or as component sourcing plus in-house compounding.
• Supplier selection is driven less by brand and more by ability to hit exact final concentrations: Dextrose 5%, Sodium chloride 0.2%, Potassium chloride 30 mEq/L, with validated sterility, labeling, and expiry.
• Procurement success depends on confirming KCl concentration basis (mEq/mL) and final bag volume so the pharmacy or supplier reaches the target 30 mEq/L precisely.

FAQs

1) Are there commercially available ready-to-use products for this exact formulation?
Often yes in some regions through contract compounding, but availability varies by local sterile compounding networks and hospital contracting.

2) Who can supply the admixture: manufacturers or pharmacies?
Either. Sterile contract manufacturers supply pre-compounded batches; regional sterile compounding pharmacies supply made-to-order admixtures.

3) If a supplier cannot make the 0.2% sodium chloride strength, can they adjust with other concentrations?
This depends on feasibility to reach the target final composition using their stocked sterile concentrates while maintaining validated compatibility and dosing.

4) What matters most for the potassium portion, 30 mEq/L?
The potassium chloride input strength (mEq/mL) and the final bag volume determine whether the final product hits 30 mEq/L.

5) What documentation should buyers require for sterile compounded IV admixtures?
Lot traceability, sterile release/assurance documentation, product specification for final concentrations, and storage/handling plus expiration assignment.

References

1. U.S. Food and Drug Administration. “Sterile Drug Products Produced by Aseptic Processing.” FDA Guidance/Regulatory content.
2. European Medicines Agency (EMA). GMP and sterile production guidance documents.