DrugDashboards

Dexmedetomidine

Dexmedetomidine · DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL · Injection, Solution · Intravenous · Gland Pharma Limited

NDC 68083-0527-25 · 25 VIAL in 1 CARTON / 2 mL in 1 VIAL · ANDA · View full market →

The short version

7 companies supply this market — a reasonable cushion if one runs into trouble. 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.

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
ANDA202126
TE code
AP
Approval date
Aug 20, 2015
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03)Apr 10, 2021
    month 65 — 3× the typical 20-month injectable shortage
  • Planned discontinuation — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93)Apr 10, 2020
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 200 ug/2 mL (NDC 66794-230-42)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)

LabelerStrengthFirst seenLast seen
Piramal Critical Care IncDEXMEDETOMIDINE HYDROCHLORIDE 200 ug/2mLJul 15, 2026Sep 3, 2026
Accord Healthcare Inc.DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mLJul 15, 2026Sep 2, 2026
Eugia US LLCDEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedDEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLCDEXMEDETOMIDINE HYDROCHLORIDE 200 ug/2mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mLJul 15, 2026Sep 2, 2026
ProPharma DistributionDEXMEDETOMIDINE HYDROCHLORIDE 200 ug/2mLJul 15, 2026Sep 2, 2026
ProPharma DistributionDEXMEDETOMIDINE 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 68083-0527-25," retrieved September 3, 2026, https://drugdashboards.com/drug/68083052725.

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