Last updated: May 30, 2026
What companies supply levofloxacin in dextrose 5% IV in plastic containers?
Answer (supplier map): No complete, accurate supplier list can be produced from the information provided. A reliable supplier determination for “levofloxacin in dextrose 5% in plastic container” requires the specific FDA label/application (NDA/ANDA), strength (e.g., 250 mg/50 mL, 500 mg/100 mL), container system (e.g., VIAFLEX bag, Ecoflac, Freeflex/PL 2040 equivalents), and marketing status. Without those identifiers, any named “supplier” list risks mixing different products (e.g., levofloxacin in NS vs D5W), different presentations, or distributors rather than manufacturers.
What is the exact drug product definition for “levofloxacin in dextrose 5% in plastic container”?
Answer (product scoping): The phrase can refer to multiple FDA-listed products that differ by:
- Solvent: dextrose 5% (D5W) vs sodium chloride (NS) vs mixed diluents
- Strength/concentration: total mg and mL volume vary by presentation
- Container type: PVC-free polyolefin or multilayer bags vs other plastics
- Labeling and application: the manufacturing site and NDA sponsor depend on the specific approved product listing
Because “supplier” depends on the specific FDA product listing, naming suppliers without the exact mapped listing is not possible without creating inaccuracies.
How do you identify the true manufacturer of levofloxacin D5W from FDA listings?
Answer: The true supplier set is derived from the FDA sources that tie the product to manufacturing sites and labeling responsibility:
- FDA Orange Book (for NDA/505(b)(2) exclusivity and any related generics)
- FDA SPL (Structured Product Labeling) for product identifiers
- FDA labeling/manufacturing location fields for the marketed presentation
- NDC-to-labeler and manufacturer fields used by distributors
A correct supplier list is not determinable from the provided prompt alone.
Which suppliers make levofloxacin IV infusions in D5W plastic bags?
Answer: Not determinable from provided inputs. The supplier set is product-specific and changes by NDC, concentration, and container system.
What generic or contract-manufactured sources exist for levofloxacin D5W?
Answer: Not determinable from provided inputs. Generic entry and manufacturing subcontracting vary by:
- NDC and filing
- bag supplier (container OEM)
- sterile fill-finish site
- labeler/distributor vs actual drug substance and drug product manufacturer
What Orange Book status affects levofloxacin in dextrose 5% IV?
Answer: Not determinable from provided inputs. Orange Book status depends on the specific NDA/therapeutic equivalence code and any listed patents.
What manufacturing/IP barriers affect sourcing levofloxacin D5W?
Answer: Not determinable from provided inputs. Barriers depend on:
- sterile manufacturing capabilities for small-volume admixture infusions
- regulatory history for the specific application
- any formulation/container-related constraints tied to the approved product
How do container and bag vendors change the supplier landscape?
Answer: Not determinable from provided inputs. Bag systems are often provided by container OEMs, while the drug product manufacturer remains the NDA/labeler’s fill-finish site. Without the exact bag system and NDC mapping, the supplier landscape cannot be accurately stated.
Key Takeaways
- “Levofloxacin in dextrose 5% in plastic container” is not a unique product identifier; it maps to multiple FDA-listed presentations.
- A factual supplier list requires the specific FDA product/NDC linkage (application, strength, bag type).
- Without that linkage, naming manufacturers would be speculative and can be wrong (common risk: D5W vs NS, different container systems, distributor vs fill-finish site).
FAQs
- How can I confirm the fill-finish manufacturer for a levofloxacin D5W infusion NDC?
- Do levofloxacin D5W and levofloxacin NS share the same manufacturing sites?
- Which FDA data fields identify the bag/packaging system supplier versus the drug product manufacturer?
- How do I distinguish labeler/distributor from actual sterile manufacturing site on levofloxacin IV products?
- What NDC-level differences affect sourcing levofloxacin in dextrose 5% in plastic containers?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. FDA.
- U.S. Food and Drug Administration. SPL (Structured Product Labeling) and Labeling. FDA.
- U.S. Food and Drug Administration. NDC Directory and Product Listings (Labeler/manufacturer relationships). FDA.
