Last updated: June 16, 2026
FLAGYL I.V. RTU IN PLASTIC CONTAINER (metronidazole) — Who Supplies It, and What Contract-Manufacturing Footprints Exist?
FLAGYL I.V. RTU in a plastic container is a branded, regulated parenteral presentation of metronidazole. The supply chain is typically centered on the brand’s NDA/label owner plus one or more contract manufacturers for the finished sterile drug product (SDP) and, in some cases, the metronidazole bulk drug substance (BDS). The key supply question for procurement, licensing, and launch-risk analysis is whether the specific RTU plastic-container configuration is produced by the same manufacturing network as other FLAGYL parenteral SKUs, or whether it is tied to a distinct sterile-fill/finish site.
No actionable, source-citable supplier list for “FLAGYL I.V. RTU in plastic container” can be provided here. Public supplier identification requires specific label-level manufacturing/packaging information (e.g., “Manufactured for…,” “Distributed by…,” storage/manufacturer addresses, NDC-specific label copy, or Drug Master File references) and/or Orange Book and FDA inspection/program linkages that are not provided in the prompt.
What companies supply FLAGYL I.V. RTU in plastic container (metronidazole) to the U.S.?
Answer (data required to be complete): The specific supplier set cannot be stated from the information provided.
What typically appears on the finished label
In the U.S., procurement-relevant manufacturer identifiers usually sit on the carton and vial/bag label, including:
- “Manufactured for” / “Manufactured by” name
- Sterile fill-finish site city/state
- NDC-specific packaging manufacturer name
- Distributor name (which is not the same as the sterile product manufacturer)
Why label/NDC specificity matters
“FLAGYL I.V. RTU in plastic container” can map to multiple NDCs depending on:
- bag size and concentration
- plastic container type (PL/COE bag type)
- RTU vs. alternative parenteral presentations
Each NDC can be produced/packaged by different sites even under the same brand.
What is the Orange Book status of FLAGYL I.V. RTU in plastic container metronidazole?
Answer (data required to be complete): Orange Book listing status cannot be produced from the prompt.
What matters for supply and generic entry risk
Orange Book data is typically used to correlate:
- NDA number(s)
- listed drug entries
- patent expiry schedules
- approved BLA/ANDA substitutes
- “Orange Book” exclusivity that can constrain supplier diversification
Without the exact NDA and listed drug name/NDC, the status cannot be mapped.
When do patents or exclusivities for FLAGYL I.V. RTU in plastic container expire, and who controls supply?
Answer (data required to be complete): Patent and exclusivity timelines cannot be calculated from the prompt.
Why the “RTU plastic container” SKU changes the analysis
Parenteral brands often have different patent sets tied to:
- formulation (concentration, excipients)
- container closure system
- manufacturing methods and sterility assurance processes
- medical use listings (method-of-use patents)
If the prompt does not provide the NDA and NDC, an accurate expiration window cannot be stated.
Which contract manufacturers produce sterile metronidazole RTU for FLAGYL?
Answer (data required to be complete): A supplier list cannot be compiled without:
- NDC-specific label/manufacturer statements, or
- FDA facility/manufacturing site linkages tied to the product, or
- publicly documented inspection outcomes tied to the exact submission.
How does FLAGYL I.V. RTU in plastic container compare with other FLAGYL forms for supplier coverage?
Answer (data required to be complete): Cross-SKU supplier comparison cannot be performed without the product’s exact NDC or label manufacturer.
What to compare across SKUs
- Is the same sterile fill-finish manufacturer used across vials vs. bags?
- Does the brand use the same packaging manufacturer for different container sizes?
- Are sites FDA-inspected under the same sterile drug production program references?
What generic entry risks exist for metronidazole IV RTU in plastic containers (and do they affect supplier lists)?
Answer (data required to be complete): Generic risk cannot be assessed without Orange Book and ANDA/P-IV/Para IV challenge status tied to the exact listed drug.
Key Takeaways
- “Suppliers for FLAGYL I.V. RTU in plastic container” cannot be answered reliably from the prompt.
- Supplier identification for this SKU must be driven by NDC-specific label manufacturing/packaging statements and/or FDA submission-to-facility mappings.
- Without NDA/NDC details or label/manufacturer identifiers, any supplier list would be non-actionable.
FAQs
- How do I identify the actual sterile manufacturer behind FLAGYL IV RTU bags by NDC?
- Do FLAGYL IV RTU plastic containers use the same contract manufacturer as FLAGYL IV premixed vials?
- Which FDA database fields can map metronidazole IV RTU manufacturing sites to NDCs?
- How can Orange Book listed drug entries change when the container closure system changes?
- What commercial procurement signals identify substitution risk for branded metronidazole IV RTU?
References
(No citable sources were provided in the prompt.)
