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Irinotecan Hydrochloride

Irinotecan Hydrochloride · IRINOTECAN HYDROCHLORIDE 40 mg/2mL · Injection · Intravenous · Ingenus Pharmaceuticals, LLC

NDC 50742-0401-02 · 1 VIAL, GLASS in 1 CARTON / 2 mL in 1 VIAL, GLASS · ANDA · 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
$10.40
Reported to Texas DSHS · 2026 annual filing · Ingenus Pharmaceuticals LLC

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

Medicare Part B (ASP)

Payment limit per 20 MG
$1.851
HCPCS J9206 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$2,934
208 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
ANDA206935
TE code
AP
Approval date
May 26, 2017
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation — Irinotecan Hydrochloride, Injection, 100 mg/5 mL (NDC 50742-402-05)Feb 24, 2026
  • Planned discontinuation — Irinotecan Hydrochloride, Injection, 40 mg/2 mL (NDC 50742-401-02)Feb 24, 2026

Recalls (this NDC)

  • Class II · TerminatedJun 8, 2018
    Ingenus Pharmaceuticals Llc — Superpotent Drug: High out of specification assay value results for potency.
  • Class II · TerminatedJun 8, 2018
    Ingenus Pharmaceuticals Llc — Superpotent Drug: High out of specification assay value results for potency.

Manufacturers of Irinotecan Hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
Hikma Pharmaceuticals USA Inc.IRINOTECAN HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 3, 2026
Gland Pharma LimitedIRINOTECAN HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Ingenus Pharmaceuticals, LLCIRINOTECAN HYDROCHLORIDE 100 mg/5mLJul 15, 2026Sep 2, 2026
Ingenus Pharmaceuticals, LLCIRINOTECAN HYDROCHLORIDE 40 mg/2mLJul 15, 2026Sep 2, 2026
Xiromed LLCIRINOTECAN HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Northstar Rx LLCIRINOTECAN HYDROCHLORIDE 20 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Irinotecan Hydrochloride — NDC 50742-0401-02," retrieved September 3, 2026, https://drugdashboards.com/drug/50742040102.

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