DrugDashboards

Irinotecan Hydrochloride

Irinotecan Hydrochloride · IRINOTECAN HYDROCHLORIDE 20 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.

NDC 00143-9701-01 · 5 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
$15.00
Reported to Texas DSHS · 2026 annual filing · Hikma Pharmaceuticals USA Inc.

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)

$27,917
1,301 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
ANDA091032
TE code
AP
Approval date
Dec 20, 2010
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 11, 2020
    Hikma Pharmaceuticals USA Inc. — Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
  • Class II · TerminatedSep 23, 2013
    West-Ward Pharmaceutical Corp. — Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
  • Class II · TerminatedSep 23, 2013
    West-Ward Pharmaceutical Corp. — Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.

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 00143-9701-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00143970101.

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