Last updated: May 28, 2026
Gentamicin sulfate in sodium chloride 0.9% injection for IV use is supplied by multiple branded and generic manufacturers through plastic-container presentations (commonly single-dose bags). Supply is split across (1) original-NDA and branded contract manufacturers and (2) generic manufacturers filing ANDAs with the FDA.
Because “suppliers” can mean either (a) drug-product manufacturers on the label or (b) distributors/contracted wholesalers, the most decision-useful view for procurement, sourcing risk, and launch planning is the set of finished-dose IV-plastic-container manufacturers that produce the drug product listed in FDA databases (ANDA holders and label manufacturers) and the procurement channels that distribute those products to health systems.
Who supplies gentamicin sulfate in 0.9% sodium chloride in plastic containers in the US?
Direct answer: The US supply base is primarily made of generic ANDA manufacturers plus any branded labelers that contract manufacturing. The supplier set for the exact presentation (“gentamicin sulfate in sodium chloride 0.9% in plastic container”) is determined by the specific NDC for the bag strength and bag size.
What “plastic container” means for sourcing and NDC mapping?
Most procurement confusion comes from NDC fragmentation:
- Route: IV infusion (not IM/SC injection).
- Solution: 0.9% sodium chloride carrier.
- Container: plastic bag (often EVA or similar).
- Strength: expressed as gentamicin (base) per volume (mg/mL) plus the total mg per bag.
- Volume: bag size drives NDC and allocation.
For sourcing, you match by NDC-11/12 (not just by product name). If the bag is not the same strength and fill volume, you should treat it as a separate commodity for supply continuity, contracts, and substitution rules.
Which companies manufacture the finished-dose product for the specific IV plastic-bag presentation?
Direct answer: Finished-dose suppliers are the ANDA holders and/or labelers that hold the FDA application for each NDC, with manufacturing often performed by contract manufacturers named on labeling and/or in FDA application records.
How to identify the correct “supplier” for procurement decisions?
For any gentamicin-sulfate-in-NS IV plastic bag:
- Use the NDC for the exact bag strength + bag volume.
- Pull the labeler/holder listed in FDA labeling and the application holder in FDA’s ANDA records.
- Track manufacturer of record from labeling and FDA listing, then layer on distributor/wholesaler availability.
Typical supplier categories in practice
- ANDA labelers / application holders: companies that commercialize the product under multiple NDCs and may shift manufacturing among contract sites.
- Contract manufacturing sites: producers of sterile IV solutions and re-packaging into plastic bags.
- Branded incumbents: less common for this specific format at present, but possible where a branded product remains marketed.
- Wholesalers / GPO channels: McKesson, Cardinal Health, AmerisourceBergen, Vizient, and similar, which distribute branded or generic NDCs rather than manufacturing.
How do suppliers compare: branded vs generic ANDA labelers?
Direct answer: Generic suppliers often compete on:
- supply allocation during shortages,
- bag fill/strength equivalence,
- ability to maintain sterile manufacturing capacity,
- contract flexibility with distribution networks.
Commercial and operational differences that affect availability
- Sterile fill-finish capacity: sterile solution and bag filling constraints drive allocation.
- Raw material sourcing: gentamicin sulfate and saline bulk availability can impact lead times.
- Regulatory status stability: multiple ANDA-approved sites reduce risk, while single-site supply increases outage probability.
What patent status matters for gentamicin sulfate in sodium chloride 0.9% plastic bags?
Direct answer: Gentamicin sulfate is an older antibiotic and the IV plastic-bag presentation is broadly generic in the US. For this specific format, market access is typically driven by ANDA approvals and manufacturing capability rather than active exclusivity barriers.
Practical sourcing implication
Procurement risk rarely hinges on “patent blocking” for this drug product. The more actionable risk factors are:
- temporary manufacturing shutdowns,
- sterile facility contamination events,
- raw material constraints,
- distribution and allocation decisions during shortage periods.
What is the FDA regulatory status and Orange Book relevance?
Direct answer: For gentamicin sulfate IV in 0.9% sodium chloride plastic container, the FDA status is reflected in:
- ANDA approvals for generic drug products,
- FDA drug product labeling for each NDC,
- Orange Book listings where applicable to patent-protected formulations or uses.
How this affects suppliers
If an ANDA is approved for the exact NDC presentation, the supplier can market that product once manufacturing and distribution are in place, subject to quality and current good manufacturing practice compliance.
What generic entry risks exist for this presentation?
Direct answer: The main “entry risk” is not patent life. It is the ability to:
- pass sterility/quality requirements at scale,
- maintain consistent bag fill/closure and container compatibility,
- sustain supply through sterile manufacturing and QC release.
Manufacturing/IP barriers that can disrupt supply
- sterile filling line downtime,
- container supplier constraints,
- viscosity/compatibility validation for the container and closure system,
- batch-to-batch release timing changes.
Supplier mapping by NDC: what you should use for sourcing contracts
Direct answer: Procurement contracts should specify NDC and strength/volume, not only the drug name.
Contract-ready specification fields
- Active ingredient: gentamicin sulfate
- Carrier: sodium chloride 0.9%
- Container type: plastic bag
- Strength: mg/mL
- Total bag volume and total gentamicin per bag
- Sterility/QC release requirements per label
- NDC and labeler/manufacturer of record (as currently listed)
- Substitution rules and allowed interchangeability under pharmacy policy
Key Takeaways
- Suppliers for gentamicin sulfate in sodium chloride 0.9% plastic containers are identified by NDC-specific ANDA labelers/manufacturers, not by the drug name alone.
- Procurement should map by exact strength, bag size, and NDC to avoid substitution errors and supply surprises.
- For a widely generic antibiotic format, availability risk is driven mainly by sterile manufacturing capacity, quality releases, and supply allocation, not by active exclusivity blocking.
FAQs
1) How do I find the exact manufacturers for gentamicin sulfate in 0.9% sodium chloride plastic bags?
Use the product NDC for the specific strength and bag volume, then extract the ANDA holder/labeler and manufacturer of record from FDA drug labeling/approval records.
2) Are plastic-container NDCs interchangeable across bag sizes and strengths?
No. Even with the same active ingredient and carrier, strength and fill volume differences create different NDCs, which can change supplier availability and billing.
3) Do gentamicin sulfate IV plastic bags have shortage-driven allocation?
Allocation occurs when sterile production capacity or QC release bottlenecks tighten. The allocation source is typically tied to the specific NDC and its manufacturing site.
4) What is the most procurement-relevant way to compare suppliers?
Compare by NDC-linked manufacturer sites, lead times, historical fill rates, and whether multiple ANDA-approved production lines exist.
5) Do patents meaningfully constrain generic supply for this drug product?
For gentamicin sulfate IV formulations, supply is generally driven by ANDA readiness and manufacturing capacity rather than active patent life, so the operational bottlenecks matter most.
References
- FDA. Orange Book: Approved Drug Products With Therapeutapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-05-28).
- FDA. Drugs@FDA: Product Details for ANDAs and NDAs. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-05-28).
