Last Updated: May 11, 2026

Suppliers and packagers for generic pharmaceutical drug: OXACILLIN SODIUM


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OXACILLIN SODIUM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Baxter Hlthcare BACTOCILL IN PLASTIC CONTAINER oxacillin sodium INJECTABLE;INJECTION 050640 NDA Baxter Healthcare Corporation 0338-1015-41 50 mL in 1 BAG (0338-1015-41) 1989-10-26
Eugia Pharma Speclts OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 201539 ANDA Eugia US LLC 55150-127-15 10 VIAL in 1 BOX (55150-127-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2013-01-18
Eugia Pharma Speclts OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 201539 ANDA Eugia US LLC 55150-128-24 10 VIAL in 1 BOX (55150-128-24) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2013-01-18
Eugia Pharma Speclts OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 201538 ANDA Eugia US LLC 55150-129-99 1 VIAL, PHARMACY BULK PACKAGE in 1 BOX (55150-129-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2013-01-18
Fresenius Kabi Usa OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 206198 ANDA Fresenius Kabi USA, LLC 63323-812-20 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-812-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-812-01) 2020-11-01
Fresenius Kabi Usa OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 206198 ANDA Fresenius Kabi USA, LLC 63323-813-20 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-813-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-813-01) 2020-11-01
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Suppliers and packagers for generic pharmaceutical drug: OXACILLIN SODIUM

Last updated: April 26, 2026

Who Supplies OXACILLIN SODIUM to the Pharmaceutical Market?

Oxacillin sodium is an injectable penicillin-class antibiotic used in hospital care for susceptible Gram-positive infections. Commercial supply is split across: (1) finished-dose injectables (brand and authorized generics) and (2) upstream API and sterile-manufacturing supply chains. Patent status and exclusivity are not the controlling constraint for “who supplies,” but regulatory capability and sterile manufacturing capacity are.

Which Companies Supply Oxacillin Sodium as a Finished Injectable?

The market for oxacillin sodium injectables is concentrated in a limited set of sterile manufacturers with approved product dossiers. Commonly distributed products are marketed under “oxacillin for injection” and are typically in 250 mg or 500 mg vials, depending on jurisdiction and labeler.

Common finished-dose labelers found in the oxacillin sodium injectable market

  • Sandoz (US labeler for oxacillin sodium injection in the historical US portfolio)
  • Hospira / Pfizer affiliates (historically active in hospital antibiotic injection portfolios)
  • Teva (historical presence in US hospital sterile injectables)
  • Apotex / parent entities (historical generics participation in hospital penicillin injectables)
  • Mylan / Viatris entities (historical generics participation in antibiotic injectables)

This list reflects typical labeler roles for oxacillin sodium injectables in large markets, where the “supplier” to providers is the labeler and wholesaler distribution network, not the API producer.

What are the typical product presentations?

While presentations vary by country and manufacturer, oxacillin sodium injectable products are usually supplied as:

  • Powder for injection in vials (reconstituted prior to administration)
  • Strengths commonly shown as 250 mg/vial or 500 mg/vial
  • Distribution into hospital purchasing channels via wholesalers and group purchasing organizations

Which Companies Supply the Oxacillin Sodium API or Sterile Manufacturing Supply Chain?

API and sterile supply tend to be less visible than finished-dose labelers. In practice, upstream suppliers often include:

  • API manufacturers (oxacillin sodium bulk drug substance)
  • Contract manufacturers (sterile vial filling and packaging, including aseptic processing and batch release)

Across the antibiotic sector, the supply chain often consolidates into a small number of antibiotic-competent plants. The most direct “supplier” signals come from:

  • API manufacturer listings on regulatory inventories (where available)
  • sterile manufacturing consortia with recurring antibiotic injectable production lines
  • authorized generic filings and contract manufacturing relationships

What Supply Constraints Matter for Oxacillin Sodium?

Oxacillin sodium supply is sensitive to:

  • Sterile manufacturing capacity for penicillin beta-lactam vials
  • Quality system readiness under current GMP and EU Annex 1 (where applicable)
  • Raw material sourcing for beta-lactam intermediates and sodium salt conversion steps
  • Global batch release bandwidth (batch testing and documentation throughput)

How to Map “Suppliers” for Procurement and R&D

For practical procurement or partnering, the market divides into three actionable supplier classes:

1) Finished-dose labelers (to hospital buyers and distributors)

  • These control product availability and packaging lead times.

2) Contract sterile manufacturers (to labelers)

  • These control fill-finish capacity, aseptic readiness, and vial/batch formats.

3) API producers (to contract sterile manufacturers and labelers)

  • These control bulk availability, impurity profiles, and API change notifications.

Supply Snapshot: Supplier Roles by Market Function

Supplier role Who it is in practice What they control What procurement should watch
Finished-dose supplier (labeler) US/EU labelers for oxacillin sodium injection Product labeling, distribution channel, lot release Shortages, NDC/PL availability, vial strength coverage
Contract sterile manufacturer CDMOs producing sterile vial products for labelers Fill-finish capacity, aseptic line scheduling Lead times, batch qualification status
API supplier Bulk drug substance manufacturers Oxacillin sodium bulk supply, impurity system API change management, CoA continuity, retest dates

Market Alternatives Used When Oxacillin Sodium Supply Tightens

When oxacillin sodium injectable supply tightens, hospitals and distributors typically substitute within the same clinical class or equivalent agents, depending on local formulary rules:

  • Nafcillin (common US alternative for MSSA-susceptible infections)
  • Cloxacillin (where available in local markets)
  • Other antistaphylococcal penicillins subject to susceptibility and label constraints

Key Takeaways

  • “Suppliers” of oxacillin sodium split into finished-dose labelers (what hospitals buy), contract sterile manufacturers (who fills and bottles), and API producers (bulk supply).
  • Market visibility is highest for finished-dose labelers; upstream API and fill-finish partners are harder to identify but drive supply continuity.
  • Shortages typically track sterile capacity and beta-lactam manufacturing scheduling rather than clinical demand.

FAQs

Who is the primary supplier for hospitals purchasing oxacillin sodium?

The primary supplier is the finished-dose labeler whose product is distributed through hospital wholesaling channels.

Is oxacillin sodium supplied by multiple manufacturers or one?

It is supplied by multiple labelers, though sterile manufacturing capacity is usually concentrated in fewer plants.

Do API suppliers determine final product availability?

Yes. When API bulk supply is disrupted or changes occur, sterile fill-finish and lot release slow accordingly.

What presentation sizes are typical for oxacillin sodium injection?

Commonly vials at strengths such as 250 mg or 500 mg, with format varying by market and labeler.

What happens during oxacillin sodium shortages?

Procurement frequently turns to class alternatives such as nafcillin or equivalent antistaphylococcal beta-lactams that meet local formularies and susceptibility requirements.

References

[1] FDA. Drug Shortages. https://www.accessdata.fda.gov/scripts/drugshortages/
[2] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] EMA. Medicines Shortages. https://www.ema.europa.eu/en/human-regulatory/overview/medicines-shortages

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