DrugDashboards

Lidocaine Hydrochloride

Lidocaine Hydrochloride Anhydrous · LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL · Injection, Solution · Epidural; Infiltration; Intracaudal; Perineural · Spectra Medical Devices, LLC

NDC 65282-1605-01 · 25 AMPULE in 1 CARTON / 5 mL in 1 AMPULE · 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 — FDA lists the reason as “other. A Class II recall hit this product in the past year (Spectra Medical Devices, Llc). One of its named manufacturing plants, Huons Co., Ltd., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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.

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
ANDA208017
TE code
AP
Approval date
Apr 18, 2018
Patents / exclusivity
None on file

Shortage history

  • In shortage now Lidocaine Hydrochloride, Injection, 10 mg/1 mL (NDC 65282-1605-1)Jun 14, 2018
    Other
    month 99 — 5× the typical 20-month injectable shortage

Recalls (this NDC)

  • Class II · OngoingMay 12, 2026
    Spectra Medical Devices, LlcLack of Assurance of Sterility

Manufacturers of Lidocaine Hydrochloride Anhydrous (Injection, Solution)

LabelerStrengthFirst seenLast seen
Henry Schein, Inc.LIDOCAINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 3, 2026
Henry Schein, Inc.LIDOCAINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Spectra Medical Devices, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mLJul 15, 2026Sep 2, 2026
Sportpharm LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Lidocaine Hydrochloride — NDC 65282-1605-01," retrieved September 3, 2026, https://drugdashboards.com/drug/65282160501.

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