DrugDashboards

Sodium Oxybate

Sodium Oxybate · SODIUM OXYBATE 500 mg/mL · Solution · Oral · Amneal Pharmaceuticals LLC

NDC 65162-0065-87 · 1 BOTTLE in 1 CARTON / 180 mL in 1 BOTTLE · ANDA · View full market →

The short version

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

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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.

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $15,752.09 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Sodium Oxybate Shared System REMS

Regulatory

Application
ANDA203631
TE code
AA
Approval date
Sep 10, 2025
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 Sodium Oxybate (Solution)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals LLCSODIUM OXYBATE 500 mg/mLJul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.SODIUM OXYBATE .5 g/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.SODIUM OXYBATE .5 g/mLJul 15, 2026Sep 2, 2026
Jazz Pharmaceuticals, Inc.SODIUM OXYBATE .5 g/mLJul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, Inc.SODIUM OXYBATE .5 g/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Sodium Oxybate — NDC 65162-0065-87," retrieved September 3, 2026, https://drugdashboards.com/drug/65162006587.

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