DrugDashboards

Levetiracetam

levetiracetam · LEVETIRACETAM 500 mg/5mL · Injection · Intravenous · Solco Healthcare US, LLC

NDC 43547-0454-10 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

14 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Zhejiang Huahai Pharmaceutical Co., Ltd., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

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
$45.00
Reported to Texas DSHS · 2026 annual filing · Solco Healthcare

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

Medicaid spend (2025)

$9,449
246 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 · avg $52.15 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA209474
TE code
AP
Approval date
Mar 28, 2022
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of levetiracetam (Injection)

LabelerStrengthFirst seenLast seen
Hikma Pharmaceuticals USA Inc.LEVETIRACETAM 100 mg/mLJul 15, 2026Sep 3, 2026
Armas Pharmaceuticals Inc.LEVETIRACETAM 100 mg/mLJul 15, 2026Sep 2, 2026
B. Braun Medical Inc.LEVETIRACETAM 10 mg/mLJul 15, 2026Sep 2, 2026
B. Braun Medical Inc.LEVETIRACETAM 5 mg/mLJul 15, 2026Sep 2, 2026
B. Braun Medical Inc.LEVETIRACETAM 15 mg/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationLEVETIRACETAM 10 mg/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationLEVETIRACETAM 5 mg/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationLEVETIRACETAM 15 mg/mLJul 15, 2026Sep 2, 2026
Civica, Inc.LEVETIRACETAM 100 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCLEVETIRACETAM 10 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCLEVETIRACETAM 15 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCLEVETIRACETAM 5 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedLEVETIRACETAM 15 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedLEVETIRACETAM 5 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedLEVETIRACETAM 10 mg/mLJul 15, 2026Sep 2, 2026
Hp Halden Pharma ASLEVETIRACETAM 5 mg/mLJul 15, 2026Sep 2, 2026
Hp Halden Pharma ASLEVETIRACETAM 10 mg/mLJul 15, 2026Sep 2, 2026
Hp Halden Pharma ASLEVETIRACETAM 15 mg/mLJul 15, 2026Sep 2, 2026
Method Pharmaceuticals, LLCLEVETIRACETAM 500 mg/5mLJul 15, 2026Sep 2, 2026
Micro Labs LimitedLEVETIRACETAM 100 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCLEVETIRACETAM 5 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCLEVETIRACETAM 15 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCLEVETIRACETAM 10 mg/mLJul 15, 2026Sep 2, 2026
Nexus Pharmaceuticals LLCLEVETIRACETAM 10 mg/mLJul 15, 2026Sep 2, 2026
Nexus Pharmaceuticals LLCLEVETIRACETAM 15 mg/mLJul 15, 2026Sep 2, 2026
Nexus Pharmaceuticals LLCLEVETIRACETAM 5 mg/mLJul 15, 2026Sep 2, 2026
Solco Healthcare US, LLCLEVETIRACETAM 500 mg/5mLJul 15, 2026Sep 2, 2026
WG Critical Care, LLCLEVETIRACETAM 15 mg/mLJul 15, 2026Sep 2, 2026
WG Critical Care, LLCLEVETIRACETAM 5 mg/mLJul 15, 2026Aug 31, 2026
WG Critical Care, LLCLEVETIRACETAM 10 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Levetiracetam — NDC 43547-0454-10," retrieved September 3, 2026, https://drugdashboards.com/drug/43547045410.

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