DrugDashboards

Methadone Hydrochloride

Methadone Hydrochloride · METHADONE HYDROCHLORIDE 10 mg/mL · Concentrate · Oral · Atlantic Biologicals Corp.

NDC 17856-0392-01 · 60 SYRINGE in 1 BOX, UNIT-DOSE / .5 mL in 1 SYRINGE · ANDA · View full market →

The short version

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

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.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for methadone hydrochloride (other) in the next 90 days

sole-source market · price up 3% YoY

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

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 · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
ANDA040180
TE code
AA
Approval date
Apr 30, 1998
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Methadone Hydrochloride (Concentrate)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackMETHADONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 3, 2026
VistaPharm, LLCMETHADONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 3, 2026
Atlantic Biologicals Corp.METHADONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Atlantic Biologicals Corp.METHADONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.METHADONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Lannett Company, Inc.METHADONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USAMETHADONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Aug 31, 2026
SpecGx LLCMETHADONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Methadone Hydrochloride — NDC 17856-0392-01," retrieved September 3, 2026, https://drugdashboards.com/drug/17856039201.

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