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.
Methadone Hydrochloride
Methadone Hydrochloride · METHADONE HYDROCHLORIDE 10 mg/mL · Concentrate · Oral · Hikma Pharmaceuticals USA
NDC 00054-0391-68 · 1000 mL in 1 BOTTLE · ANDA · View full market →
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
Estimated fill cost
WAC per package, as filed
$51.02
Reported to Texas DSHS · 2026 annual filing · Hikma Pharmaceuticals USA Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$38
1,747 prescriptions paid by Medicaid nationally · all Medicaid spend →
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 →
Where it's made
- West-Ward Columbus Inc.United Statesmanufacture
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
- ANDA089897
- TE code
- AA
- Approval date
- Sep 6, 1988
- 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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Bryant Ranch Prepack | METHADONE HYDROCHLORIDE 10 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| VistaPharm, LLC | METHADONE HYDROCHLORIDE 10 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Atlantic Biologicals Corp. | METHADONE HYDROCHLORIDE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Atlantic Biologicals Corp. | METHADONE HYDROCHLORIDE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA Inc. | METHADONE HYDROCHLORIDE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | METHADONE HYDROCHLORIDE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA | METHADONE HYDROCHLORIDE 10 mg/mL | Jul 15, 2026 | Aug 31, 2026 |
| SpecGx LLC | METHADONE HYDROCHLORIDE 10 mg/mL | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Methadone Hydrochloride — NDC 00054-0391-68," retrieved September 3, 2026, https://drugdashboards.com/drug/00054039168.
Free to cite with attribution — see how the data is put together.