DrugDashboards

palonosetron hydrochloride

palonosetron hydrochloride · PALONOSETRON HYDROCHLORIDE .25 mg/5mL · Injection · Intravenous · Cipla USA Inc.

NDC 69097-0927-35 · 1 VIAL in 1 CARTON / 5 mL in 1 VIAL · NDA AUTHORIZED GENERIC · View full market →

The short version

5 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
$130.00
Reported to Texas DSHS · 2023 annual filing · Cipla USA Inc.

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

Medicaid spend (2023)

$106,089
27 prescriptions paid by Medicaid nationally · all Medicaid spend →

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
NDA021372
TE code
Approval date
Jul 25, 2003
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 palonosetron hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
BLuePoint LaboratoriesPALONOSETRON HYDROCHLORIDE .25 mg/5mLJul 16, 2026Sep 3, 2026
Baxter Healthcare CorporationPALONOSETRON HYDROCHLORIDE .25 mg/5mLJul 15, 2026Sep 2, 2026
Cipla USA Inc.PALONOSETRON HYDROCHLORIDE .25 mg/5mLJul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.PALONOSETRON HYDROCHLORIDE .075 mg/1.5mLJul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.PALONOSETRON HYDROCHLORIDE .25 mg/5mLJul 15, 2026Sep 2, 2026
Apotex Corp.PALONOSETRON HYDROCHLORIDE .25 mg/5mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "palonosetron hydrochloride — NDC 69097-0927-35," retrieved September 3, 2026, https://drugdashboards.com/drug/69097092735.

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