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Suppliers and packagers for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
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DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
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 40MEQ | 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 |
Suppliers and packagers for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
DEXTROSE 5% + SODIUM CHLORIDE 0.2% + POTASSIUM CHLORIDE 40 mEq Suppliers: Who Manufactures and Distributes This IV Electrolyte Solution?
Who supplies dextrose 5%, sodium chloride 0.2%, and potassium chloride 40 mEq IV solutions?
This three-component IV solution is typically supplied by large injectable-solutions manufacturers and national wholesalers/distributors that carry ready-to-administer IV products. Exact supplier lists depend on the market (US vs. EU vs. other regions), container configuration (bag size, bottle), and whether the product is a hospital unit-dose item or a bulk manufacturing SKU.
Core supply model
- Primary manufacturers: Sterile IV solution producers with capability for aqueous dextrose and electrolyte compounding under GMP (including PWA/large-volume sterile liquids).
- Channel distributors: Wholesalers that provide procurement pathways to hospitals and GPOs.
- Repackagers/compounders (limited): Where allowed, some regions use repackaging or pharmacy compounding; these generally operate outside the label and may not match the exact finished-goods strength.
Which companies manufacture the exact IV strength: dextrose 5% + sodium chloride 0.2% + potassium chloride 40 mEq?
In practice, finished-goods availability of this exact combination is constrained by:
- formulation manufacturing lines for low-concentration saline in the same bag as dextrose and high KCl content
- sterile fill-finish capacity for potassium-containing solutions
- regulatory labeling of potassium as 40 mEq per specified bag volume (strength is often expressed per bag, per liter, or as KCl content depending on the label)
Actionable procurement approach used by buyers
- Search the label strength exactly as written (including “40 mEq”) and the container (bag size, units).
- Match suppliers through GPO contract catalogues and wholesaler availability feeds by NDC (US) or equivalent product identifiers (EU/other).
- For tendering, require certificate of analysis, sterility assurance documentation, and container closure system specs tied to the exact manufacturer.
Because suppliers are not identifiable from the strength statement alone (there is no single universal manufacturer for this formulation across all geographies and container sizes), a complete, correct list cannot be produced from the information provided.
What distributor network supplies these IV bags to hospitals and wholesalers?
Hospital purchasing typically flows through:
- national wholesalers (carrying multiple manufacturers under the same product strength)
- GPO inventory networks
- direct supply agreements for larger accounts
- emergency allocation processes when shortages occur
Procurement indicators that correlate with supplier identification
- whether the product is listed under a specific national catalog number (NDC in the US)
- whether it is stocked at main distribution centers (not regional only)
- whether it is available via GPO standardization (often the fastest path to identifying “official supplier” for tendering)
How does container size change supplier availability for this formulation?
For combination electrolyte-dextrose IV solutions, container size and fill volume materially affect:
- regulatory presentation (label strength per bag)
- manufacturing campaign size and packaging SKU
- stocking patterns at wholesalers
Even when the active concentrations match, a supplier might carry:
- 500 mL vs 1000 mL presentations
- different overwrap/sterile barrier systems
- different package configurations (single unit vs case packs)
A supplier roster built only on the concentration statement often fails at procurement because the same “strength” is not interchangeable across package sizes.
What patent or regulatory listings determine which suppliers can sell it?
Supply is constrained by:
- whether the product is on the reference-listed drug (RLD) basis (US) or has an approved marketing authorization in the destination country
- whether it is a sterile, large-volume injection with controlled formulation and labeling
- whether it is marketed as a finished sterile product or assembled from component inputs under compounding rules (jurisdiction-dependent)
For the US, the fastest way to validate the legal marketing status and identity of the approved supplier is via product listings tied to the exact NDC and FDA approval status. Without that identifier, supplier identification cannot be made reliably.
Is this product more likely to be sourced during shortages from specific suppliers?
During electrolyte shortages, allocation tends to concentrate supply among:
- manufacturers with the closest upstream supply chain for KCl and dextrose
- plants with spare sterile fill-finish capacity
- firms with existing approvals for similar large-volume sterile liquids
That said, shortage-time supplier rosters change quickly and are not derivable from the strength string alone.
Key suppliers vs. channel distributors: how to separate “who makes it” from “who sells it”?
For procurement and contracting, buyers must distinguish:
- Manufacturer of record: the labeled holder of marketing authorization for the finished IV solution.
- Wholesaler/distributor: the commercial reseller providing supply to hospitals.
- Repackager/secondary packer: may move product through the chain but does not own the finished-goods approval.
A procurement package should request:
- label manufacturer name
- NDC or equivalent product code
- lot-level traceability
- expiration dating and quarantine history policies
Key Takeaways
- “DEXTROSE 5% + SODIUM CHLORIDE 0.2% + POTASSIUM CHLORIDE 40 mEq” is a strength description, not a unique product identifier.
- Supplier identification requires the exact labeled presentation (including bag size and product code such as NDC in the US).
- Finished-goods IV electrolyte solutions are supplied by GMP sterile IV manufacturers, with hospitals served through national wholesalers and GPO networks; repackagers/compounders may appear but do not provide the same “official finished-goods” continuity.
FAQs
- How do I identify the exact NDC for D5% with NaCl 0.2% and KCl 40 mEq?
- Are the suppliers the same for 500 mL vs 1000 mL presentations of this IV electrolyte solution?
- Can hospitals source this formulation through GPO contracts, and how do I validate the manufacturer?
- What documentation should be required from wholesalers for KCl-containing IV bags during shortages?
- Does pharmacy compounding replicate this exact formulation, and how does that affect procurement and compliance?
References (APA)
- FDA. (n.d.). Orange Book and drug listings. U.S. Food and Drug Administration.
- FDA. (n.d.). Drug approval and labeling resources. U.S. Food and Drug Administration.
- FDA. (n.d.). National Drug Code (NDC) directory. U.S. Food and Drug Administration.
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