DrugDashboards

esmolol hydrochloride

esmolol hydrochloride in sodium chloride · ESMOLOL HYDROCHLORIDE 10 mg/mL · Injection · Intravenous · Eugia US LLC

NDC 55150-0420-10 · 10 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 250 mL in 1 BAG · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. 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
$1,398.00
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
$0.230
HCPCS J1805 · 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
ANDA216244
TE code
AP
Approval date
Mar 21, 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 esmolol hydrochloride in sodium chloride (Injection)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals LLCESMOLOL HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCESMOLOL HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Eugia US LLCESMOLOL HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Eugia US LLCESMOLOL HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCESMOLOL HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCESMOLOL HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
WG Critical Care, LLCESMOLOL HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
WG Critical Care, LLCESMOLOL HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "esmolol hydrochloride — NDC 55150-0420-10," retrieved September 3, 2026, https://drugdashboards.com/drug/55150042010.

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