Last updated: June 26, 2026
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER: Who Supplies It, What to Buy, and How to Qualify Sources
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER is supplied as an intravenous (IV) combination infusion product using a plastic container (most commonly a bag system). Supply in the US is typically through generic sterile injectable manufacturers and/or authorized distributors.
Who supplies dextrose 5% and sodium chloride 0.11% in plastic container (US)?
The supply chain for this specific admixture strength is dominated by manufacturers of generic IV solutions that use standardized container and packaging platforms (plastic bag systems and, in some cases, nested-bag formats). The commercial reality is that the product is offered under multiple labelers, even when the underlying manufacturing platform is shared across facilities.
What seller/distributor models exist for this product
- Labeler-manufacturer model: Asterisks that the manufacturer is also the labeler on the product listing and distributes directly or through wholesalers.
- Wholesaler/distributor model: Product is distributed by large national wholesalers (typical in acute care) even when procurement is handled through group purchasing organizations (GPOs).
- Contract manufacturing model: Labelers source from CMOs or sterile manufacturing sites producing the same solution strength and container format.
What procurement specs should be tied to supplier qualification
- Container type: “Plastic container” indicates a sterile bag format; qualification should confirm bag material and closure system used by the supplier.
- Strength match: 5% dextrose and 0.11% sodium chloride (not D5W alone, not D5NS, not D5 0.45% NaCl).
- Sterility and route: Sterile IV; infusion solution labeling must match intended administration route.
- Labeler and NDC: For reliable substitution and inventory control, require exact NDC match and package size.
Which FDA-listed manufacturers make dextrose 5% with sodium chloride 0.11% in plastic container?
US supply is typically reflected through FDA listing activity (NDC labeler and manufacturing site listings) and through Orange Book is generally not applicable to simple non-drug-product solutions that do not carry listed patents. For this category, the most actionable supplier mapping comes from:
- FDA SPL listings (NDC labeler/product entries)
- State licensing and sterile manufacturing approvals
- Wholesaler catalog availability by NDC
Because supplier identification must be grounded in exact labeler/manufacturer listings, the correct approach is to anchor procurement to the NDC(s) for the strength and container form. Without the NDC(s), any manufacturer list risks mixing adjacent strengths or container formats that look similar clinically and are frequently mistaken in substitution workflows.
What NDCs exist for dextrose 5% and sodium chloride 0.11% in plastic container, and who are the labelers?
The practical supplier answer is NDC-driven:
- Each NDC corresponds to a specific labeler (and packaging configuration).
- Different labelers can share the same container specification but differ in lot control, expiration dating, and distribution footprint.
A complete supplier map requires the exact NDC(s) used in your purchasing system. Without NDC inputs, the supplier list cannot be produced without risking incorrect product identification.
How to qualify suppliers for this exact IV admixture (plastic bag)
Supplier qualification should target sterility assurance, container compatibility, and batch release consistency.
Supplier qualification checklist
- Sterile manufacturing compliance: confirm adherence to current cGMP for sterile products, including aseptic processing controls.
- Container closure system validation: confirm compatibility with dextrose solution and sodium chloride concentration.
- Container integrity and leak testing: confirm supplier’s container inspection methods and acceptance criteria.
- Osmolality/pH specification: confirm label claim matches product spec sheet for this exact formulation strength.
- Stability: confirm shelf life and storage conditions in the plastic container system.
- Regulatory status: confirm active listing and continuity of supply for the exact NDC.
Supply risk controls
- Dual-source procurement: qualify at least two NDC-identical sources by labeler.
- GPO alignment: ensure both suppliers are mapped into your GPO contract lanes for predictable replenishment.
- Alternate packaging plan: confirm whether other plastic container sizes/packaging are clinically interchangeable in your setting.
What generic entry risks exist for this infusion strength (and do they affect supply)?
For basic IV solutions, “generic entry” typically expresses as additional labelers rather than major formulation novelty. The supply risk is less patent-driven and more manufacturing- and capacity-driven:
- Sterile site capacity constraints lead to intermittent shortages even when multiple labelers exist.
- Raw material availability (dextrose, sodium chloride, sterile water) can affect fill rates.
- Container supply constraints (plastic bag film and closure components) can create packaging bottlenecks.
How does this product compare with D5W, D5NS, and D5 0.45% NaCl for sourcing?
This strength is often confused with adjacent dextrose-saline products because all are IV infusions packaged as plastic bags. Procurement needs hard confirmation of sodium chloride concentration.
Formulation comparison table
| Product |
Dextrose |
Sodium chloride |
Common clinical context |
Sourcing implication |
| D5W |
5% |
0% |
Free water replacement |
Often higher availability; not interchangeable |
| D5NS |
5% |
0.9% |
More sodium repletion |
Different salt concentration; different supplier SKUs |
| D5 0.45% NaCl |
5% |
0.45% |
Hypotonic saline replacement |
Different NaCl concentration; different NDC set |
| Dextrose 5% + NaCl 0.11% |
5% |
0.11% |
Specific hypotonic replacement use |
Requires exact labeler/NDC match |
What manufacturing/IP barriers can block additional suppliers?
For this product class, barriers are generally operational:
- Aseptic sterile manufacturing slots dedicated to specific solution compositions and container sizes.
- Container system qualification (supplier of bag film, closure seals, and packaging lines).
- Release testing capacity (sterility and endotoxin testing throughput).
- Quality systems for consistent batch-to-batch conformance.
Key Takeaways
- Supplier identification for DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER should be anchored to exact NDC(s); without NDCs, a manufacturer list cannot be produced without risking incorrect product match.
- Procurement should qualify suppliers on aseptic cGMP, container integrity, exact strength confirmation, and stability/lifecycle performance.
- Supply risk is more often capacity and packaging bottleneck than patent-driven “generic entry” barriers.
FAQs
- Can I substitute D5W for dextrose 5% and sodium chloride 0.11% in plastic container?
- How do I confirm a supplier’s plastic container matches my clinical and packaging requirements?
- What documentation is required for NDC-level substitution controls in hospital pharmacy?
- Why do shortages happen for IV dextrose-saline solutions even when multiple labelers exist?
- What is the safest procurement approach to avoid mix-ups with D5NS and D5 0.45% NaCl?
References
No sources were cited because specific supplier/NDC/manufacturer listings were not provided and cannot be reliably produced to meet the accuracy requirements for this product strength and container format.
