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Suppliers and packagers for POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
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POTASSIUM CHLORIDE 0.15% 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 0.15% 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 |
Suppliers and packagers for POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
Potassium Chloride 0.15% in Dextrose 5% (KCl/D5W) Suppliers by Product Form, Container Type, and Manufacturer
Executive summary: Potassium chloride in dextrose 5% (commonly labeled “KCl in D5W” or “potassium chloride in dextrose injection”) is typically sourced in two ways: (1) wholesalers distributing finished sterile infusion solutions and (2) sterile compounding providers preparing patient-specific admixtures in plastic infusion containers. Because “0.15% KCl in Dextrose 5% in plastic container” maps to an admixture strength and container format that often varies by supplier catalog and local labeling, supplier availability is best analyzed by channel (FDA-approved finished product vs. compounded sterile preparation) and by container format (plastic infusion bag vs. bottle).
Which companies supply potassium chloride 0.15% in dextrose 5% for infusion in plastic containers?
Direct-sale (finished sterile product) suppliers
- Finished sterile infusions at the exact “0.15% potassium chloride in Dextrose 5%” strength are frequently supplied under manufacturer labeling as a premixed IV solution. Distribution is usually handled by national wholesalers (AmerisourceBergen, Cardinal Health, McKesson) plus regional wholesalers, depending on hospital contract terms.
- For the specific concentration and container (“plastic container”), supplier lists change with procurement cycles, National Drug Codes used by each distributor, and container presentation (bag vs. bottle).
Sterile compounding (hospital/outsourced 503A/503B)
- Many health systems obtain this exact concentration through outsourced pharmacy compounding when a branded finished product is not available under contract, when container format must match institutional preference, or when patient-specific adjustments are required.
- Typical compounding supply chain includes:
- 503A pharmacies (hospital-affiliated or independent compounding pharmacies)
- 503B outsourcing facilities (larger-scale sterile manufacturing)
- GPO and distributor-facilitated sourcing for compounders
What supplier channels provide KCl/D5W admixtures: wholesaler, hospital pharmacy, or 503B outsourcing facility?
Wholesalers
- Wholesalers generally source from approved manufacturers and then fulfill hospital purchase orders. They do not “make” the admixture at the stated concentration unless the item is sold as a finished IV solution.
Hospital pharmacy compounding
- Hospital pharmacy may compound admixtures in plastic bags using sterile powders/solutions and perform quality controls under USP <797> requirements.
Outsourced sterile compounding (503B)
- 503B facilities provide “outsourced sterile drug products” and can be a practical route for KCl/D5W strength matching and container standardization, particularly for health systems with centralized purchasing.
How do plastic container requirements change supplier options for potassium chloride in D5W?
Plastic container requirements affect procurement in three practical ways:
-
Container materials and compatibility
- Plastic bags must be compatible with electrolyte solutions and meet the institution’s standard operating procedures.
-
Presentation differences
- Many suppliers offer KCl in D5W in specific volume sizes (for example 100 mL, 250 mL, 500 mL, or 1,000 mL) and in specific bag types.
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Contract-specific NDC and catalog SKUs
- “Plastic container” often maps to a particular product presentation and NDC. Even if two companies both offer “KCl in D5W,” the exact NDC and bag configuration can differ.
Which distributors typically carry potassium chloride in dextrose 5% and manage hospital procurement?
Supplier lists in practice are shaped by distributor coverage:
- AmerisourceBergen
- Cardinal Health
- McKesson
These distributors typically carry a range of IV electrolytes and premixed solutions and can also route orders to compounding partners when the exact admixture format is not stocked as a finished product. Hospital contracts dictate which channels are feasible.
What manufacturing base suppliers make potassium chloride in dextrose 5% solutions used for infusion?
For this specific strength format, finished products are typically produced by sterile drug manufacturers with IV electrolyte lines. The key operational identifiers are:
- Sterile manufacturing capability for IV solutions
- Ability to make admixtures or premixes at defined KCl concentration in D5W
- Packaging in approved plastic infusion containers (bag and size)
In many markets, the same “KCl in D5W” SKU can be manufactured by a small set of sterile IV producers, then redistributed by multiple wholesalers. If a health system requires exact concentration and plastic container size, purchasing often locks onto the NDC/SKU that matches that presentation.
What 503B outsourcing facilities supply KCl/D5W admixtures in plastic bags?
Common outsourcing approach
- Outsourcing facilities that support sterile electrolytes can supply admixtures prepared to order or prepared as defined strengths with standardized container presentations.
Procurement reality
- Outsourcing facility availability is often dynamic and depends on:
- facility-specific sterile workflow capacity
- stability/sterility release testing processes for electrolyte admixtures
- contract pharmacy coverage requirements
How many supplier sources exist for KCl 0.15% in Dextrose 5% in plastic containers?
Answer
- The supply base typically splits into:
- A limited number of finished-product manufacturers for standardized premixed electrolyte solutions.
- A larger number of compounding pharmacies and fewer large-scale 503B facilities that can match defined concentrations and plastic bag formats.
Practical supplier count
- Finished premix sources at the exact label strength are usually fewer than the number of compounding providers capable of preparing it.
What are the main risks in sourcing potassium chloride 0.15% in dextrose 5%: availability, lead times, and substitution?
Sourcing risk is dominated by:
-
Finished product discontinuation or substitution
- If the premixed NDC is unavailable, distributors may propose an alternative presentation or strength.
-
Container format substitution
- Bag type and volume can change, affecting institutional compatibility requirements.
-
Compounding capacity constraints
- For compounded supply, lead times can rise when sterile compounding capacity is constrained or when demand spikes.
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Labeling and strength verification
- Multiple “KCl in dextrose” concentrations exist in market catalogs. Mis-ordering risk increases when orders are placed by description only instead of NDC/SKU.
How does shortage history affect suppliers for KCl in D5W?
KCl admixtures and D5W infusion solutions can be impacted by:
- raw material lead times (potassium chloride, dextrose injection)
- sterile fill-finish and packaging line constraints
- market-wide IV shortage cycles
When shortages occur, supplier strategy typically shifts from finished-product procurement to compounding routes that can match the desired concentration and container format.
What to look for in supplier qualification for KCl/D5W in plastic containers (sterility and quality systems)?
For hospital procurement and pharmacy qualification, supplier documentation generally includes:
- sterile manufacturing controls aligned with USP compounding and sterile production standards
- container closure integrity controls
- stability and compatibility data for electrolyte admixtures
- COA availability and batch traceability
- adverse event and recall response capability
Key Takeaways
- Supply of “potassium chloride 0.15% in dextrose 5% in plastic container” typically comes from either (1) finished premixed sterile IV solution manufacturers distributed by national wholesalers or (2) sterile compounding providers preparing the admixture in plastic infusion bags to match concentration and container requirements.
- Distributor availability is often the fastest route for identifying workable sources, but exact concentration and container format usually require locking to the correct NDC/SKU.
- In periods of constrained supply, outsourcing sterile compounding (503B and sometimes 503A) is the most common alternative to maintain strength and packaging consistency.
FAQs
1) What is the most reliable supplier path for KCl 0.15% in D5W in a plastic bag?
Directly procure the finished premix by NDC/SKU via major wholesalers when available; otherwise use a qualified sterile compounding partner that can confirm strength and container compatibility.
2) Can wholesalers supply KCl/D5W compounded admixtures or only finished products?
Wholesalers primarily distribute finished products; some can route orders to compounding partners, but that depends on local contract arrangements and whether the item is sold as a finished premix.
3) What container size and bag type should be specified to prevent substitution risk?
Specify the exact volume and bag type used by the institution and tie the order to the correct NDC/SKU rather than description alone.
4) Are 503B facilities able to standardize KCl in D5W concentrations more consistently than hospital compounding?
Often yes for standardized strengths, but consistency depends on the facility’s sterile workflow capacity and release testing practices for electrolyte admixtures.
5) How should procurement handle KCl concentration mismatches across “in dextrose” SKUs?
Require unit-by-unit verification against the ordered concentration label (and NDC/SKU) at receiving and before dispensing.
References
- USP. USP <797> Pharmaceutical Compounding-Sterile Preparations. United States Pharmacopeia.
- FDA. Outsourcing Facilities (503B). U.S. Food and Drug Administration.
- FDA. Drug Shortages. U.S. Food and Drug Administration.
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