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Levetiracetam

Levetiracetam in sodium chloride · LEVETIRACETAM 1500 mg/100mL · Injection, Solution · Intravenous · Eugia US LLC

NDC 55150-0248-47 · 10 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 100 mL in 1 BAG · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, Eugia Pharma Specialities Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

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.

Estimated fill cost

WAC per package, as filed
$400.00
Reported to Texas DSHS · 2026 annual filing · Eugia Us Llc

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 10 MG
$0.032
HCPCS J1953 · Jul 1, 2026 quarter · typically ASP + 6%

Supply fragility

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

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

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
ANDA207160
TE code
AP
Approval date
Jan 4, 2017
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedMar 27, 2018
    AuroMedics Pharma LLCLack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
  • Class II · TerminatedMar 27, 2018
    AuroMedics Pharma LLCLack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
  • Class II · TerminatedMar 27, 2018
    AuroMedics Pharma LLCLack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Manufacturers of Levetiracetam in sodium chloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Eugia US LLCLEVETIRACETAM 1000 mg/100mLJul 15, 2026Sep 2, 2026
Eugia US LLCLEVETIRACETAM 1500 mg/100mLJul 15, 2026Sep 2, 2026
Eugia US LLCLEVETIRACETAM 500 mg/100mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Levetiracetam — NDC 55150-0248-47," retrieved September 3, 2026, https://drugdashboards.com/drug/55150024847.

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