DrugDashboards

Methadone Hydrochloride

Methadone Hydrochloride · METHADONE HYDROCHLORIDE 10 mg/5mL · Solution · Oral · SpecGx LLC

NDC 00406-6221-05 · 500 mL in 1 BOTTLE · ANDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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 00054-3556-63) — 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
$0.1136per unit
middle half $0.0839$0.1350 · 4,771 plans · Apr 1, 2026
Est. net of rebates
≈ $0.1136
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
87%of plans cover it
tier 3 · prior auth 40% · step therapy 0% · qty limit 95%

*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

$0$0.05$0.1$0.15Dec 2024Jul 2025$0.1024
8 price points · per ML · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$55.26
Reported to Texas DSHS · 2026 annual filing · SpecGX LLC

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2023)

$13
11 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

5Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 5 active manufacturers+5

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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 →

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
ANDA207537
TE code
AA
Approval date
Oct 1, 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 (Solution)

LabelerStrengthFirst seenLast seen
Precision Dose, Inc.METHADONE HYDROCHLORIDE 5 mg/5mLJul 15, 2026Sep 3, 2026
American Health PackagingMETHADONE HYDROCHLORIDE 5 mg/5mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.METHADONE HYDROCHLORIDE 10 mg/5mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.METHADONE HYDROCHLORIDE 5 mg/5mLJul 15, 2026Sep 2, 2026
SpecGx LLCMETHADONE HYDROCHLORIDE 10 mg/5mLJul 15, 2026Sep 2, 2026
SpecGx LLCMETHADONE HYDROCHLORIDE 5 mg/5mLJul 15, 2026Sep 2, 2026
VistaPharm, LLCMETHADONE HYDROCHLORIDE 5 mg/5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Methadone Hydrochloride — NDC 00406-6221-05," retrieved September 3, 2026, https://drugdashboards.com/drug/00406622105.

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