DrugDashboards

Methadone Hydrochloride

Methadone Hydrochloride · METHADONE HYDROCHLORIDE 10 mg/1 · Tablet · Oral · XLCare Pharmaceuticals, Inc

NDC 72865-0121-01 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00406-5771-01) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of saleⓘ
$0.2499per unit
middle half $0.2079–$0.3016 · 5,442 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.2499
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
99%of plans cover it
tier 3 · prior auth 42% · step therapy 0% · qty limit 94%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

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 (oral solid) in the next 90 days

sole-source market

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 →

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 · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
ANDA211228
TE code
AA
Approval date
Jan 3, 2019
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 (Tablet)

LabelerStrengthFirst seenLast seen
American Health PackagingMETHADONE HYDROCHLORIDE 10 mg/1Aug 6, 2026Sep 3, 2026
Ascend Laboratories, LLCMETHADONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCMETHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Aurolife Pharma, LLCMETHADONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Aurolife Pharma, LLCMETHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackMETHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, IncMETHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, IncMETHADONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Elite Laboratories, Inc.METHADONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Elite Laboratories, Inc.METHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma, LLCMETHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma, LLCMETHADONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.METHADONE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.METHADONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.METHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsMETHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
SpecGx LLCMETHADONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
SpecGx LLCMETHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
SpecGx LLCMETHADONE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
VistaPharm, LLCMETHADONE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
VistaPharm, LLCMETHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, IncMETHADONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, IncMETHADONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Methadone Hydrochloride — NDC 72865-0121-01," retrieved September 3, 2026, https://drugdashboards.com/drug/72865012101.

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