The short version
8 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.
Irinotecan Hydrochloride
Irinotecan Hydrochloride · IRINOTECAN HYDROCHLORIDE 20 mg/mL · Injection, Solution · Intravenous · Qilu Pharmaceutical Co., Ltd.
NDC 67184-0513-01 · 1 VIAL, SINGLE-USE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-USE · 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
- analysis · label · 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
- ANDA203380
- TE code
- AP
- Approval date
- May 3, 2016
- Patents / exclusivity
- None on file
Shortage history
- Planned discontinuation — Irinotecan Hydrochloride, Injection, 100 mg/5 mL (NDC 25021-230-05)Sep 26, 2025
- Planned discontinuation — Irinotecan Hydrochloride, Injection, 40 mg/2 mL (NDC 25021-230-02)Sep 26, 2025
- Planned discontinuation — Irinotecan Hydrochloride, Injection, 20 mg/1 mL (NDC 45963-614-51)Aug 4, 2025
- Planned discontinuation — Irinotecan Hydrochloride, Injection, 20 mg/1 mL (NDC 45963-614-55)Aug 4, 2025
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Irinotecan Hydrochloride (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Apotex Corp. | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Eugia US LLC | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Pharmacia & Upjohn Company LLC | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Actavis Pharma, Inc. | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Fresenius Kabi USA, LLC | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Hospira, Inc. | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Sagent Pharmaceuticals | IRINOTECAN HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Qilu Pharmaceutical Co., Ltd. | 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 67184-0513-01," retrieved September 3, 2026, https://drugdashboards.com/drug/67184051301.
Free to cite with attribution — see how the data is put together.