DrugDashboards

Dexmedetomidine Hydrochloride

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride · DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL · Injection, Solution · Intravenous · Eugia US LLC

NDC 55150-0296-10 · 10 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 50 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. It is in shortage right now. One of its named manufacturing plants, Eugia Pharma Specialities Limited, 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
$250.00
Reported to Texas DSHS · 2026 annual filing · Eugia Us Llc

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

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
ANDA210321
TE code
AP
Approval date
Dec 7, 2020
Patents / exclusivity
None on file

Shortage history

  • In shortage now Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage
  • In shortage now Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Eugia US LLCDEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Dexmedetomidine Hydrochloride — NDC 55150-0296-10," retrieved September 3, 2026, https://drugdashboards.com/drug/55150029610.

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