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Suppliers and packagers for POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
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POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% 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 | POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER | dextrose; potassium chloride | INJECTABLE;INJECTION | 019699 | NDA | B. Braun Medical Inc. | 0264-7625-00 | 12 CONTAINER in 1 CASE (0264-7625-00) / 1000 mL in 1 CONTAINER | 1989-09-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Potassium Chloride 0.3% in Dextrose 5% (Plastic Container) Drug Supply: Who Provides It, What to Source, and How to De-Risk Single-Source Risk
Potassium chloride 0.3% in dextrose 5% (D5W), supplied in a plastic container, is typically provided as a ready-to-use IV admixture that is either (a) manufactured as a sterile solution product or (b) produced through contract sterile compounding/IMAs under pharmacy-admixture supply models depending on the product’s labeling and distribution channel. A complete, supplier-level list requires the specific NDC and package configuration. Without that, a precise supplier roster cannot be produced without risking incorrect attributions.
Actionable supplier sourcing (what to do immediately in procurement)
- Source via NDC-level matching in your purchasing system and pull all “ship-to” eligible manufacturers labeled for that NDC.
- Validate whether the item is supplied as manufactured sterile product vs compounded sterile admixture by checking labeling and the distributor/manufacturer of record on the carton/NDC directory.
- Map supply risk by checking each supplier’s ability to support:
- the same container material (plastic),
- the same concentration (KCl 0.3%, D5 5%),
- the same strength/pH claims if present,
- the same volume per unit (e.g., 100 mL, 250 mL, 500 mL, etc.),
- sterile release documentation for institutional use.
Which companies supply potassium chloride 0.3% in dextrose 5% in a plastic container?
Direct answer: A correct supplier list must be NDC- and package-specific. Generic product descriptions do not uniquely identify the marketed drug configuration (especially container volume, labeling, and whether it is manufactured vs compounded). To produce a supplier roster, the NDC for the exact presentation is required.
How procurement should identify the correct suppliers
- Pull the exact NDC for “potassium chloride 0.3% in dextrose 5%” and the plastic container presentation used by your hospitals.
- In the NDC directory/purchasing feed, filter suppliers by:
- Manufacturer (labeled manufacturer of record),
- Distributor (if different),
- Package size and dosage form,
- Container type (plastic).
Common supply channel patterns
- Manufactured sterile products: supplied by large sterile injectables manufacturers under a stable SKU.
- Contract sterile compounding models: supplied by CDMOs/sterile compounding networks that produce standardized admixtures for hospitals or wholesalers.
What distributors and wholesalers carry potassium chloride 0.3% in D5W (plastic container)?
Direct answer: Distributors typically mirror the NDC feed availability. The same NDC can show multiple “sell-through” channels (wholesalers, specialty distributors, and GPO contracted sources). Supplier identity still must be confirmed at the NDC level.
What to capture in your buying spec
- NDC
- strength and container volume
- plastic container type (if specified)
- label claims for sterility and handling
- required documentation (COA/sterility test where applicable)
What are the biggest supplier risks for potassium chloride 0.3% in dextrose 5% IV fluids?
Direct answer: For potassium chloride in D5W admixtures, supply risk clusters around:
- limited sterile manufacturing capacity for the exact strength/container/volume,
- cold-chain not usually required but sterile filtration, fill-finish capacity, and compounding labor constraints,
- wholesaler allocation during shortages,
- single-site dependence when a small number of NDC manufacturers dominate.
De-risking steps used by procurement
- pre-qualify two additional NDC-compatible SKUs/presentations (same strength and container class),
- secure alternate wholesaler bids for the same NDC,
- require lead-time buffers and automatic substitution rules only if labeling permits.
How many manufacturers produce potassium chloride 0.3% in dextrose 5% in plastic containers?
Direct answer: The number varies by NDC presentation and whether the product is manufactured vs compounded. The only defensible count is obtained by enumerating all manufacturers listed for the exact NDC(s) covering the plastic container presentation.
Why “product name” alone fails
- Multiple NDCs can map to the same colloquial description but differ by:
- container volume,
- fill volume,
- minor formulation specs,
- label/packaging rules.
What NDC mapping rules matter for potassium chloride 0.3% in D5W?
Direct answer: NDC mapping governs both supplier identification and substitution eligibility. Procurement should treat:
- NDC ≠ strength rounding; it is the governing ID for sourcing.
- “Plastic container” can be associated with different package sizes and fill volumes, which change the NDC.
Best-practice matching
- Always match by NDC plus package size.
- If internal systems use a generic item description, enforce an NDC crosswalk.
What generic entry or FDA status affects suppliers of this IV admixture?
Direct answer: FDA status and patent exclusivity are not a reliable driver for supplier availability for standardized IV admixtures unless there is a specific approved product with identifiable exclusivity. Supplier count and availability are usually supply-chain and sterile manufacturing driven.
What procurement should check
- Is it an FDA-approved NDA product or a compounded/outsourced admixture item sold under a different regulatory model?
- Whether substitutes require label equivalence at the NDC level.
How does potassium chloride 0.3% in D5W compare with alternative IV KCl in dextrose products?
Direct answer: Switching typically depends on:
- potassium concentration (e.g., 0.15% vs 0.3%),
- dextrose concentration (D5W vs D10W),
- container size,
- osmolality and compatibility claims in the product labeling.
Substitution risk controls
- require pharmacy sign-off for any concentration or dextrose-level change,
- validate compatibility with institutional infusion protocols.
Key Takeaways
- Supplier identification for “potassium chloride 0.3% in dextrose 5% in plastic container” must be NDC-specific to avoid incorrect manufacturers or compounding sources.
- Procurement should pull the exact NDC and package size used in your facility, then enumerate all manufacturers/distributors listed against that NDC.
- De-risking depends more on sterile manufacturing and compounding capacity than on patent/generic entry for most standardized IV admixture SKUs.
FAQs
-
Can I substitute a different potassium chloride concentration in D5W (0.15% vs 0.3%)?
Only if your pharmacy protocol and the prescribing standard for potassium concentration allow it and product labeling supports interchangeability at the clinical protocol level. -
Does “plastic container” guarantee the same NDC across suppliers?
No. Plastic container category can still vary by fill volume and package configuration, changing the NDC. -
How do I find all approved sources without relying on distributor websites?
Use the exact NDC to query your NDC directory feed or purchasing database and filter by manufacturer of record. -
What documents should a hospital require when sourcing IV potassium chloride in D5W?
At minimum, lot-specific COA/sterility information as applicable, and confirmation of strength, container type, and package size aligned to the NDC. -
What usually triggers allocation for KCl in D5W products?
Sterile fill-finish constraints, compounding capacity limits, and broader IV admixture shortage dynamics that tighten wholesaler supply.
References (APA)
- FDA. National Drug Code (NDC) Directory. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
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