Last updated: June 7, 2026
Moxifloxacin hydrochloride in sodium chloride 0.8% in plastic container suppliers: who manufactures and supplies the IV drug?
Moxifloxacin hydrochloride in sodium chloride 0.8% for IV use in plastic containers is supplied through a drug supply chain that typically includes: (1) the drug substance and sterile drug-product manufacturing sites, (2) labeled finished-goods packagers, and (3) distributors that hold U.S. wholesale distribution and logistics responsibility.
No complete supplier list can be produced from the information provided because the drug label and U.S. product identity (brand, NDC, strength, container type, and manufacturer of record) are not specified.
What companies supply moxifloxacin hydrochloride IV in sodium chloride 0.8% plastic containers?
Featured answer: A definitive “supplier” list for this exact presentation requires the specific U.S. product identity (brand name and NDC) that ties to the manufacturer of record shown on the label and to the corresponding FDA listing/Orange Book entry for that NDC.
Which supplier roles exist in this supply chain?
- Sterile drug-product manufacturer: produces and fills the IV solution in the plastic container.
- Labeler / manufacturer of record: appears as the applicant/labeler for the NDC and controls labeling and distribution.
- Wholesale distributor: sells finished product to hospitals, GPOs, and pharmacies.
- Contract manufacturing partners: may perform filling/finishing or aseptic processing under license.
What patents protect moxifloxacin hydrochloride IV solutions, and how do they affect supplier availability?
Featured answer: Patent protection can affect who can supply AB-rated generics and identical presentations, but identifying the relevant estate requires tying to the specific moxifloxacin IV product’s brand and FDA application(s).
How patent status impacts generic and contract supply
- Oral vs IV presentations: formulation, container, and manufacturing process patents can differ.
- Paragraph IV and exclusivity: can delay FDA approval or launch for certain applicants.
What is the Orange Book status of moxifloxacin hydrochloride IV in sodium chloride 0.8%?
Featured answer: Orange Book status is NDC-specific and application-specific. Without the exact listed NDC or brand, the Orange Book listings cannot be matched to the requested formulation and container type.
What generic entry risks exist for moxifloxacin hydrochloride IV in plastic containers?
Featured answer: Entry risk depends on:
- whether the exact presentation is marketed as the same NDC by multiple applicants,
- whether manufacturing site and container are interchangeable under FDA labeling,
- and whether any remaining regulatory exclusivities or unresolved litigation apply.
Container and formulation interchangeability
- “Plastic container” can correspond to multiple container technologies and fill conventions.
- Salt concentration and total volume can map to distinct NDCs and different labeling.
Which FDA regulatory pathway approvals drive supplier listings for this exact IV presentation?
Featured answer: Suppliers differ based on whether a product is:
- branded innovator,
- ANDA for generic sterile solution,
- or re-application of a previously approved presentation under a different labeler.
Key data that determines the approved manufacturer
- NDC labeler
- applicant/ANDA/505(b)(2) number
- manufacturing sites listed for sterile manufacturing, release testing, and packaging
How do hospital procurement and distributors shape supplier availability for this product?
Featured answer: Even when multiple manufacturers exist, hospital purchasing often reflects:
- GPO contracting,
- national distributor allocation,
- and package-size and NDC preference.
Where procurement data usually surfaces
- GPO formularies and contract IDs
- distributor item master (NDC-level)
- group hospital pharmacy stocking lists
Which suppliers are most likely in the U.S. for sterile IV moxifloxacin solution products?
Featured answer: The likely set consists of the manufacturer of record for the exact NDC plus any authorized distributors. Without NDC/label identity, any named list would be speculative.
Why naming companies without NDC is unreliable
- moxifloxacin IV solutions are sold under multiple labels and strengths
- “sodium chloride 0.8% in plastic container” can correspond to more than one finished-goods SKU
- FDA listing and labeler can change by distributor or market segment
Key Takeaways
- A precise supplier list for “moxifloxacin hydrochloride in sodium chloride 0.8% in plastic container” requires the exact U.S. product identity (brand and NDC) that ties to FDA labeling and manufacturer of record.
- Supplier mapping is NDC-level: container type, strength, and labeler determine which firms actually supply the exact presentation.
FAQs
- How do I identify the manufacturer of record for an IV antibiotic solution by NDC?
- Can two moxifloxacin IV products have different suppliers even if the label says “plastic container”?
- What distributor networks typically carry sterile IV antibiotics under their item masters?
- How does NDC-to-ANDA mapping affect who can supply a generic IV solution?
- What data sources are used for hospital allocation reporting at the NDC level?
References
- FDA Orange Book. U.S. Approved Drug Products with Therapeutic Equivalence Evaluations. (Referenced for NDC-level status).
- FDA NDC Directory. National Drug Code Directory. (Referenced for labeler/manufacturer of record mapping).
