DrugDashboards

Dexmedetomidine Hydrochloride

dexmedetomidine hydrochloride · DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL · Injection · Intravenous · Slayback Pharma LLC

NDC 71225-0126-04 · 10 VIAL in 1 CARTON / 20 mL in 1 VIAL · ANDA · View full market →

The short version

6 companies supply this market — a reasonable cushion if one runs into trouble. It is in shortage right now — FDA lists the reason as “other”.

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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.

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
ANDA212791
TE code
AP
Approval date
Dec 4, 2019
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05)Jun 5, 2026
  • Planned discontinuation — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-06)Jun 5, 2026
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24)Apr 10, 2020
    Other
    month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of dexmedetomidine hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
Baxter Healthcare CompanyDEXMEDETOMIDINE HYDROCHLORIDE 400 ug/100mLJul 15, 2026Sep 3, 2026
Gland Pharma LimitedDEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mLJul 15, 2026Sep 3, 2026
Piramal Critical Care IncDEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mLJul 15, 2026Sep 3, 2026
Wilshire Pharmaceuticals, Inc.DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mLJul 15, 2026Sep 3, 2026
Sagent PharmaceuticalsDEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CompanyDEXMEDETOMIDINE HYDROCHLORIDE 200 ug/50mLJul 15, 2026Aug 31, 2026
Civica, Inc.DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mLJul 15, 2026Aug 31, 2026
Slayback Pharma LLCDEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mLJul 15, 2026Jul 29, 2026

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

Cite this page

DrugDashboards, "Dexmedetomidine Hydrochloride — NDC 71225-0126-04," retrieved September 3, 2026, https://drugdashboards.com/drug/71225012604.

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