Suppliers and packagers for POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% 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 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	potassium chloride; sodium chloride	INJECTABLE;INJECTION	019708	NDA	B. Braun Medical Inc.	0264-7865-00	12 CONTAINER in 1 CASE (0264-7865-00) / 1000 mL in 1 CONTAINER	1989-09-29

Potassium Chloride 0.075% in Sodium Chloride 0.9% (Plastic Container) Suppliers: Who Manufactures and Supplies the IV Solution in the U.S.?

Last updated: June 5, 2026

Major suppliers for potassium chloride 0.075% in sodium chloride 0.9% (IV solution, plastic container) are the companies that own and market the specific NDC-labeled presentations on U.S. shelves through wholesalers and GPO channels. These products are typically marketed under multiple NDCs depending on container size and labeler.

Who are the main suppliers for potassium chloride 0.075% in sodium chloride 0.9% IV (plastic container)?

Suppliers generally fall into three buckets: (1) manufacturers with FDA-approved facilities and NDA/ANDA labeling rights, (2) private labelers/GPO brands, and (3) distribution partners. The supply chain is dominated by the manufacturers that produce sterile potassium chloride in normal saline admixture-style IV solutions and ship in plastic containers (often ViaFlex or equivalent).

Common U.S. manufacturer/labeler groups active in sterile IV electrolyte products

The market for potassium chloride in 0.9% sodium chloride includes large sterile injectables manufacturers and specialty IV producers. These companies typically cover multiple electrolyte strengths and container formats, including plastic.

Primary supplier entities to check first (by labeler/NDC on the box):

• Hospira (Pfizer)
• Baxter
• B. Braun
• ICU Medical
• Fresenius Kabi
• Sagent
• Hikma (where applicable by product line and NDC)
• Exela PharmaSciences (where applicable by contract manufacturing/labeling)

Distribution channel suppliers (who “supply” to hospitals)

Hospitals often receive the product via GPO/wholesale distribution. Common U.S. distributors include:

• McKesson
• Cardinal Health
• AmerisourceBergen

These firms usually do not manufacture the sterile IV solution. They supply the product after the manufacturer/labeler releases inventory.

What suppliers make potassium chloride in 0.9% sodium chloride IV solutions in plastic containers?

The manufacturing of sterile IV solutions is controlled by facility and labeling controls. For this specific strength and container type, the manufacturer is identified by the FDA labeler and the NDC for the exact pack (concentration and container volume).

How to identify the correct “supplier” for this exact concentration

Use the product labeler shown on the packaging or the NDC listing:

• If the NDC list shows labeler = a company, that company is the “supplier” for compliance and procurement.
• If the product is private-labeled, the NDC labeler is still the entity responsible for the listed drug product.

Why container type matters for supplier mapping

Plastic container lines are typically produced using standardized bag formats, and procurement lists may restrict by:

• Bag brand family (generic “plastic container” vs specific bag system)
• Bag volume (commonly 100 mL, 250 mL, 500 mL, 1000 mL classes)
• Overwrap and packaging configuration

A supplier that makes one container size may not make every size.

Which companies supply this potassium chloride/saline IV strength under GPO or hospital brand names?

GPO/private label is common in IV sterile electrolytes. Under these arrangements:

• The GPO brand may show a different distributor or hospital label name.
• The NDC “labeler” still points to the actual NDA/ANDA holder for the marketed presentation.

Supplier patterns to expect

• Hospitals commonly stock “bought-in” IV electrolyte solutions under contract with a GPO.
• Multiple manufacturers can be interchangeable clinically, but substitution is driven by the NDC and packaging format.

How many suppliers cover potassium chloride 0.075% in sodium chloride 0.9% in plastic containers?

For this exact combination (0.075% KCl + 0.9% NaCl, plastic container), the number of viable suppliers is usually limited because:

• sterile electrolyte products require validated compounding/sterile filling and stability controls
• demand can be relatively specific to clinical protocols and pharmacy formularies
• shortages often occur, pulling in alternate labelers or container sizes

In most IV electrolyte niches, the effective supply base is often single digits at the NDC level (but can vary by container size).

What is the Orange Book status of potassium chloride 0.075% in sodium chloride 0.9%?

This specific question is typically resolved via Orange Book listings for the exact drug product (route, strength, dosage form). For sterile IV solutions, the Orange Book record governs the application and listed patents and exclusivity (if any).

However, Orange Book status is presentation-specific. A correct answer requires the exact marketed product identifiers (NDC/labeler and dosage form) to map to the correct Orange Book entry.

When does exclusivity end for potassium chloride 0.075% in sodium chloride 0.9% IV solutions?

Exclusivity and patent timing depend on:

• the application type (NDA vs ANDA)
• any listed patents in the Orange Book
• whether the product is subject to 180-day exclusivity for first-filer ANDAs

This again is NDC-labeler specific.

What generic entry risks exist for potassium chloride 0.075% in sodium chloride 0.9% (plastic container)?

Generic entry risk is driven by:

• sterile manufacturing capacity and inspections
• stability and package compatibility testing for the plastic container system
• whether multiple strengths are made on the same line (capacity constraints can ripple)

If the market has few labelers, risks of supply disruption increase even when “generic” appears available in abstract.

What formulation and process patents protect potassium chloride 0.075% in sodium chloride 0.9%?

Patent protection in electrolyte IV solutions typically covers:

• composition/formulation (sometimes tied to specific concentrations and stability)
• container/packaging compatibility
• manufacturing process validation and sterility assurance
• method-of-use is less common for basic IV electrolytes, but dosing protocols can appear in separate use-related patents in some therapeutic categories

This requires Orange Book and patent record mapping to the exact drug product.

What patent litigation affects suppliers of this potassium chloride/saline IV solution?

Litigation in injectable electrolyte products is usually less visible than oncology or biologics, but supply and exclusivity disputes can arise at the ANDA/patent-listing stage.

A litigation impact assessment must match:

• the exact drug product identifiers
• the paragraph IV/PGR status for the correct application

Which biosimilar risks apply to potassium chloride 0.075% in sodium chloride 0.9%?

Biosimilar frameworks do not apply because this is a small-molecule electrolyte IV solution, not a biologic.

How does potassium chloride 0.075% in sodium chloride 0.9% compare with other KCl strengths in normal saline (supplier switching)?

Procurement substitution often happens by:

• different KCl % strength (e.g., 0.05%, 0.1%, 0.15% classes)
• different bag size
• different labeler/manufacturer

Switching suppliers or strengths can trigger protocol non-interchangeability if dosing calculations are concentration-sensitive.

Key Takeaways

• “Suppliers” for this product are identified at the NDC labeler/manufacturer level, with hospital distribution commonly handled by major wholesalers.
• Major sterile IV manufacturers with broad electrolyte portfolios are the most likely sources, but the exact supplier list depends on the specific NDC presentation (bag volume, labeler, plastic container system).
• Orange Book status, exclusivity, patents, and litigation are presentation-specific and require direct mapping to the exact drug product record.

FAQs

1. How can hospitals verify the manufacturer for potassium chloride 0.075% in sodium chloride 0.9% using only the box label?
2. What NDC differences typically exist between potassium chloride 0.075% bags of different volumes?
3. Can distributors substitute another potassium chloride strength in the same normal saline bag format during shortages?
4. Do plastic container brands (bag systems) affect supplier selection for electrolyte IV solutions?
5. What procurement factors matter most for IV potassium chloride/saline availability: labeler, bag size, or package system?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. DailyMed. U.S. National Library of Medicine.
3. FDA Drug Shortages database. U.S. Food and Drug Administration.