The short version
5 companies supply this market — a reasonable cushion if one runs into trouble.
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Irinotecan hydrochloride
Irinotecan hydrochloride · IRINOTECAN HYDROCHLORIDE 20 mg/mL · Injection · Intravenous · Gland Pharma Limited
NDC 68083-0382-01 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →
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
- Gland Pharma LimitedIndiaanalysis · manufacture
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
- ANDA212993
- TE code
- AP
- Approval date
- Nov 18, 2019
- 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)
No enforcement reports list this package NDC.
Manufacturers of Irinotecan hydrochloride (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Gland Pharma Limited | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, LLC | IRINOTECAN HYDROCHLORIDE 100 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, LLC | IRINOTECAN HYDROCHLORIDE 40 mg/2mL | Jul 15, 2026 | Sep 2, 2026 |
| Xiromed LLC | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx LLC | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Irinotecan hydrochloride — NDC 68083-0382-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68083038201.
Free to cite with attribution — see how the data is put together.