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Lefamulin Acetate

Lefamulin Acetate · LEFAMULIN ACETATE 150 mg/15mL · Injection, Solution · Patheon Italia S.p.A.

NDC 68225-0105-00 · 144 VIAL in 1 CASE / 15 mL in 1 VIAL · DRUG FOR FURTHER PROCESSING · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
TE code
Approval date
Patents / exclusivity

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Lefamulin Acetate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Meitheal Pharmaceuticals Inc.LEFAMULIN ACETATE 150 mg/15mLJul 24, 2026Aug 28, 2026
Patheon Italia S.p.A.LEFAMULIN ACETATE 150 mg/15mLJul 15, 2026Aug 26, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Lefamulin Acetate — NDC 68225-0105-00," retrieved September 3, 2026, https://drugdashboards.com/drug/68225010500.

Free to cite with attribution — see how the data is put together.