DrugDashboards

Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride

DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride · DEXMEDETOMIDINE HYDROCHLORIDE 400 ug/100mL · Injection · Intravenous · Baxter Healthcare Company

NDC 43066-0557-12 · 12 BAG in 1 CARTON / 100 mL in 1 BAG · ANDA · 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. One of its named manufacturing plants, Baxter Healthcare Corporation, 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
$28.08
Reported to Texas DSHS · 2026 annual filing · Baxter Healthcare Corporation

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
ANDA208532
TE code
AP
Approval date
Aug 21, 2018
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (NDC 0781-3494-95)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (NDC 0781-3495-95)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12)Apr 10, 2020
    month 77 — 4× the typical 20-month injectable shortage
  • In shortage now — Dexmedetomidine Hydrochloride, Injection, 80 mcg/20 mL (NDC 0781-3493-95)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)

LabelerStrengthFirst seenLast seen
Sandoz Inc.DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mLJul 15, 2026Sep 3, 2026
Baxter Healthcare CompanyDEXMEDETOMIDINE HYDROCHLORIDE 200 ug/50mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CompanyDEXMEDETOMIDINE HYDROCHLORIDE 400 ug/100mLJul 15, 2026Sep 2, 2026
ProPharma DistributionDEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride — NDC 43066-0557-12," retrieved September 3, 2026, https://drugdashboards.com/drug/43066055712.

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