Suppliers and packagers for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

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DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% 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	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631	NDA	B. Braun Medical Inc.	0264-7608-00	12 CONTAINER in 1 CASE (0264-7608-00) / 1000 mL in 1 CONTAINER	1988-02-24
B Braun	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631	NDA	B. Braun Medical Inc.	0264-7608-10	24 CONTAINER in 1 CASE (0264-7608-10) / 500 mL in 1 CONTAINER	1988-02-24
B Braun	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631	NDA	B. Braun Medical Inc.	0264-7610-00	12 CONTAINER in 1 CASE (0264-7610-00) / 1000 mL in 1 CONTAINER	1988-02-24

Pharmaceutical Suppliers for Dextrose 2.5% and Sodium Chloride 0.2% in Plastic Containers: Who Makes the Bulk Solution and Who Supplies the Finished Product

Last updated: May 31, 2026

Suppliers depend on whether you buy bulk solution under a drug master file (DMF) or purchase an FDA-sterile, packaged finished dosage form (plastic container). This depends on the intended use (hospital pharmacy admixture, direct infusion, or contract manufacturing). The market typically splits between (1) large sterile injectables manufacturers that package in plastic bags (flexible containers) and (2) specialty chemical suppliers that provide dextrose and sodium chloride bulk inputs, sometimes via DMFs into sterile manufacturers’ processes.

Which companies supply Dextrose 2.5% and Sodium Chloride 0.2% in plastic container solutions?

What is the exact product form you buy: finished packaged infusion vs bulk API-grade inputs?

• Finished product: sterile dextrose-saline infusion in a flexible plastic container (common hospital use).
• Inputs only: pharmaceutical-grade dextrose (D-glucose) and sodium chloride, supplied as bulk chemicals to sterile drug manufacturers.

Because “dextrose 2.5% and sodium chloride 0.2%” is an IV combination solution, most hospital-facing supply is through finished sterile injectables or contract sterile fill-finish providers. Bulk chemical suppliers rarely sell “the combination solution”; they sell dextrose and sodium chloride separately.

Finished dosage-form suppliers (sterile packaged products)

The primary suppliers are typically:

• Major sterile injectables manufacturers with flexible-container lines (common packaging for IV fluids).
• Hospital/IDN brands supplied by contract manufacturers (private label).

Who supplies dextrose (2.5%) and sodium chloride (0.2%) for IV sterile combination products?

Dextrose suppliers

Typical categories:

• Large glucose and dextrose manufacturers that sell pharmaceutical-grade dextrose monohydrate or anhydrous dextrose for sterile manufacturing.
• Suppliers that can provide DMF/CoA support for pharmaceutical applications.

Sodium chloride suppliers

Typical categories:

• Pharmaceutical-grade sodium chloride producers using USP/EP quality systems.
• Suppliers with robust impurity specifications for sterile injectables.

What are the most common plastic container types for dextrose-saline IV solutions?

Container formats

• Flexible plastic bags (PVC-free options exist depending on formulation and manufacturer).
• Small-volume vs larger-volume containers driven by facility dosing patterns and regulatory packaging requirements.

How container choice affects sourcing

The container system and materials can change which sterile line you can use and which supplier is eligible for a specific product label and NDC.

How do you qualify suppliers for sterile IV dextrose-saline plastic containers?

Qualification criteria used by pharma procurement

• Sterility assurance and terminal sterilization/aseptic process details.
• GMP inspection history for sterile injectables.
• Container closure integrity and leachables/extractables documentation.
• Stability program for the labeled shelf life.
• Supply continuity for critical production inputs (dextrose and sodium chloride are usually available; sterile packaging and container components can be constrained).

What supply risks affect dextrose-saline IV plastic solutions?

Input supply risk vs packaging risk

• Dextrose and sodium chloride supply is usually less constrained than sterile packaging.
• Packaging components (bags, seals, connectors) can drive allocation.
• Cold-chain is usually not required for dextrose-saline, but storage and handling specifications still matter for requalification and shipment.

What is the FDA regulatory sourcing structure for IV dextrose-saline products?

How the market is mapped

• Finished products are listed under an NDC with labeling, strength, and container type.
• Manufacturers typically run sterile fill-finish and container packing under NDA/ANDA product programs.
• Contract manufacturing agreements often include raw-material control plus finished-product release testing.

How does sourcing differ by intended use: hospital IV administration vs contract sterile manufacturing?

Hospital pharmacy direct purchase

• Buy the finished infusion product with finished label and container system matched to clinical workflows.
• Supplier selection focuses on NDC availability, allocation history, and lead-time reliability.

Contract manufacturing / private label

• Qualification centers on cGMP, change control, comparability, and extractables/leachables.
• Raw material sourcing is governed by the sterile manufacturer’s validated process and approved vendor list.

Who can contract manufacture dextrose-saline IV solutions in plastic containers?

Common contract sterile manufacturing capabilities

• Sterile compounding and fill-finish in flexible containers.
• Labeling and distribution support.
• Stability and compatibility packages for container closure systems.

What documentation should a supplier provide for this specific combination solution?

Core documents procurement usually requests

• Certificate of Analysis (CoA) per lot for labeled strengths.
• Sterility assurance and bioburden release results.
• Endotoxin testing documentation.
• Container closure integrity testing results (and/or extractables/leachables reports).
• Stability summary and shelf-life statement.

Key Takeaways

• “Dextrose 2.5% and sodium chloride 0.2% in plastic container” is typically sourced as a finished sterile IV infusion product, not as a bulk chemical combination.
• Supplier landscape splits between finished sterile injectables manufacturers (plastic bag filling and packaging) and separate bulk chemical suppliers for dextrose and sodium chloride inputs.
• Qualification is driven by sterility assurance, container system compatibility (leachables/extractables), validated GMP processes, and supply continuity, not just raw-material availability.

FAQs

1. Are there DMF holders for dextrose and sodium chloride used in sterile IV solutions?
2. Which plastic bag materials (PVC-free vs PVC) are commonly used for dextrose-saline IV combinations?
3. What causes shortages for dextrose-sodium chloride IV products: API inputs or bag/connector components?
4. How do hospital formularies handle NDC substitutions for dextrose-saline plastic containers during allocation?
5. What testing does procurement require for sterile IV fluids beyond CoA (endotoxin, sterility, CCI)?

References

1. U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”). FDA.
2. U.S. Food and Drug Administration. Drug Shortages. FDA.
3. European Medicines Agency. Guideline on quality of medicinal products. EMA.