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Nalmefene Hydrochloride

Nalmefene Hydrochloride · NALMEFENE HYDROCHLORIDE 1 mg/mL · Injection, Solution · Intramuscular; Intravenous; Subcutaneous · Knoa Pharma LLC

NDC 59011-0960-10 · 10 VIAL, GLASS in 1 CARTON / 2 mL in 1 VIAL, GLASS · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles.

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.

Estimated fill cost

WAC per package, as filed
$300.00
Reported to Texas DSHS · 2026 annual filing · Purdue Pharma LP

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

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
ANDA212955
TE code
AP
Approval date
Feb 8, 2022
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 Nalmefene Hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Knoa Pharma LLCNALMEFENE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Knoa Pharma LLCNALMEFENE HYDROCHLORIDE 1.5 mg/.5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Nalmefene Hydrochloride — NDC 59011-0960-10," retrieved September 3, 2026, https://drugdashboards.com/drug/59011096010.

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