Last updated: June 1, 2026
Lidocaine Hydrochloride 0.1% and Dextrose 5% in a plastic container is typically sourced as a specialty IV additive in plastic infusion containers (commonly VIAFLEX or PL 244-style systems) via drug product manufacturers and contract manufacturing/bottling partners that fill, label, and package combination solutions for hospital distribution.
However, an authoritative supplier list requires a defined FDA product record (NDC) or manufacturer/labeler name, because multiple equivalent-strength combinations exist across different container formats, labelers, and distribution networks. Without a specific NDC labeler or listing source, any “suppliers” list would risk mixing non-equivalent products (wrong container type, different concentration, different salt form, or different route).
What suppliers provide “lidocaine hydrochloride 0.1% + dextrose 5%” in plastic containers?
Direct answer: Suppliers are the FDA labeler/manufacturer(s) for the exact NDC presentation matching:
- Active ingredients: lidocaine hydrochloride 0.1% and dextrose 5%
- Dosage form: injection solution
- Packaging: plastic container (not glass; not prefilled syringe unless explicitly labeled)
Typical supplier categories
- Primary drug product manufacturers with sterile fill-finish for small-volume/IV solutions in plastic containers.
- Contract manufacturing organizations that perform aseptic compounding, sterile filling, and packaging for a labeler.
- Distribution “suppliers” (wholesalers and hospital distributors) that may not manufacture the product but are the point of purchase for hospitals.
Which companies are actual manufacturers for lidocaine HCl 0.1% and dextrose 5% in plastic containers?
Direct answer: The manufacturer set must be taken from:
- FDA NDC Directory (labeler/manufacturer names tied to the exact strength and container)
- Orange Book (if listed) or FDA product labels for the listed presentation
A correct supplier identification depends on the exact NDC for the plastic container presentation. Different NDCs can reflect different labelers even for the same strength.
How to distinguish “plastic container” presentations in supplier sourcing
- Container material and system (commonly PVC-free bags and related systems)
- Fill volume (e.g., 100 mL vs 250 mL vs larger bags)
- Sterility and route labeling
- Labeler name vs manufacturing site
Do suppliers vary by container size or container system (VIAFLEX/PL 244 vs other)?
Direct answer: Yes. Plastic container systems often differ by:
- Bag type (material, oxygen/moisture barrier, connector type)
- Volume and fill line
- Compatibility labeling (small-volume add-ons vs primary infusion)
These differences can shift the manufacturer and contract fill-finish partner even when the active strengths remain constant.
What is the FDA status for lidocaine HCl 0.1% + dextrose 5% in plastic containers?
Direct answer: FDA status is determined per NDC:
- Whether it is an approved NDA/BLA product or an FDA-licensed compounded product (less common for sterile commercial IV combinations)
- Whether it has AB-rated generic equivalents or multiple labelers for the same presentation
Supplier access for procurement is constrained by the approved label and current manufacturing authorization tied to the NDC.
How do generic and alternative-brand suppliers affect availability?
Direct answer: Availability changes when:
- The product’s labeler undergoes site changes (different manufacturing plant)
- There is shortage or discontinuation at the manufacturer level
- Alternate labelers launch under different NDCs for the same strength/container configuration
A supplier plan should map:
- Active NDCs in the market
- Current manufacturing labeler(s)
- Historical shortage patterns tied to that specific NDC presentation
What documentation procurement teams should require from suppliers?
Direct answer: For this sterile IV-type solution in plastic containers, buyers typically require:
- Certificate of Analysis (CoA) per lot
- Sterility assurance documentation aligned to the product’s manufacturing license
- Labeling that matches the exact strength and container system
- Current Good Manufacturing Practice (cGMP) attestation or DMF/sterile manufacturing compliance references as applicable
Key takeaways
- Correct supplier identification for lidocaine hydrochloride 0.1% + dextrose 5% in plastic container requires the exact NDC presentation because labeler/manufacturer names differ across container systems and volumes.
- Procurement should be NDC-driven: map labeler/manufacturer from FDA listings for the exact plastic container strength and volume, then identify contract packaging/fill-finish partners behind each labeler.
- Generic/alternate-brand suppliers can exist under different NDCs and materially affect availability and lead times.
FAQs
1) Can I source lidocaine HCl 0.1% + dextrose 5% from wholesalers without knowing the manufacturer?
Yes for purchasing, but for compliance and supply continuity you still need NDC-to-manufacturer traceability.
2) Are compounding pharmacy suppliers an acceptable substitute for commercial plastic-container products?
Only if substitution is permitted by your regulatory and quality framework; the safest substitution is one with matching NDC label and sterile packaging specifications.
3) What matters most when switching between “plastic container” suppliers?
NDC match, container system, fill volume, connector type, and labeling for route and concentration.
4) How do I confirm supplier legitimacy for a sterile IV combination?
Use FDA NDC Directory mapping to labeler/manufacturer names and obtain CoA and labeling matching that NDC per lot.
5) Do shortages usually track the active ingredients or the NDC presentation?
In practice, shortages track the specific NDC presentation because manufacturing and fill-finish capacity are tied to container system and packaging lines.
References
- U.S. Food and Drug Administration. NDC Directory.
- FDA Orange Book (where applicable for listed references).
