DrugDashboards

Dexmedetomidine

Dexmedetomidine · DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL · Injection, Solution, Concentrate · Intravenous · WG Critical Care, LLC

NDC 44567-0601-04 · 4 VIAL in 1 CARTON / 10 mL in 1 VIAL · NDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. It is in shortage right now.

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
$133.23
Reported to Texas DSHS · 2026 annual filing · WG Critical Care

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

Medicaid spend (2025)

$80
102 prescriptions paid by Medicaid nationally · all Medicaid spend →

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
NDA206628
TE code
AP
Approval date
Oct 21, 2015
Patents / exclusivity
4 patents, 0 exclusivities
TypeNumber / codeExpires
patent9717796Apr 20, 2036
patent9649296Apr 20, 2036
patent9717796Apr 20, 2036
patent9649296Apr 20, 2036

Shortage history

  • In shortage now Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage
  • In shortage now Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage
  • In shortage now Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage
  • In shortage now Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02)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 (Injection, Solution, Concentrate)

LabelerStrengthFirst seenLast seen
WG Critical Care, LLCDEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mLJul 15, 2026Sep 3, 2026
Avenacy Inc.DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCDEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Dexmedetomidine — NDC 44567-0601-04," retrieved September 3, 2026, https://drugdashboards.com/drug/44567060104.

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