DrugDashboards

Palonosetron Hydrochloride

palonosetron hydrochloride · PALONOSETRON HYDROCHLORIDE .05 mg/mL · Injection, Solution · Intravenous · Avenacy, Inc.

NDC 83634-0777-05 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

7 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.

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
$15.00
Reported to Texas DSHS · 2026 annual filing · Avenacy, Inc

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

Medicare Part B (ASP)

Payment limit per 25 MCG
$0.574
HCPCS J2469 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$11,526
996 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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
ANDA202951
TE code
AP
Approval date
Jun 29, 2021
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation — Palonosetron Hydrochloride, Injection, .25 mg/5 mL (NDC 0703-4094-01)Nov 14, 2025

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of palonosetron hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Eugia US LLCPALONOSETRON HYDROCHLORIDE .25 mg/5mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.PALONOSETRON HYDROCHLORIDE .25 mg/5mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCPALONOSETRON HYDROCHLORIDE .25 mg/5mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsPALONOSETRON HYDROCHLORIDE .05 mg/mLJul 15, 2026Sep 2, 2026
Teva Parenteral Medicines, Inc.PALONOSETRON HYDROCHLORIDE .25 mg/5mLJul 15, 2026Sep 2, 2026
Sandoz IncPALONOSETRON HYDROCHLORIDE .25 mg/5mLJul 15, 2026Aug 31, 2026
Avenacy, Inc.PALONOSETRON HYDROCHLORIDE .05 mg/mLJul 15, 2026Aug 5, 2026

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

Cite this page

DrugDashboards, "Palonosetron Hydrochloride — NDC 83634-0777-05," retrieved September 3, 2026, https://drugdashboards.com/drug/83634077705.

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