Data / Drug companies / Irinotecan hydrochloride
Irinotecan hydrochloride: 12 companies and 23 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Irinotecan hydrochloride is listed in the FDA National Drug Code Directory by 12 companies, with 23 products in commercial distribution. 19 of the products (82.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; injection; injection, powder, for solution, and the newest product started marketing on December 30, 2024.
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- Companies listing it
- 12
- Products
- 23
- Generic (ANDA) products
- 19 (82.6%)
- Application numbers
- 9
- Routes
- Intravenous
- Brand names
- Camptosar, Onivyde
- openFDA record search
- api.fda.gov
Companies that list irinotecan hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Eugia US LLC | 4 | injection, solution | Generic drugs (ANDA) | April 11, 2022 |
| Hikma Pharmaceuticals USA Inc. | 3 | injection | Generic drugs (ANDA) | December 20, 2010 |
| Pharmacia & Upjohn Company LLC | 3 | injection, solution | New drug applications (NDA) | December 30, 2024 |
| Qilu Pharmaceutical Co., Ltd. | 3 | injection, solution | Generic drugs (ANDA) | May 3, 2016 |
| Apotex Corp. | 2 | injection, solution | Generic drugs (ANDA) | July 1, 2023 |
| NorthStar Rx LLC | 2 | injection | Generic drugs (ANDA) | November 15, 2020 |
| Actavis Pharma, Inc. | 1 | injection, solution | Generic drugs (ANDA) | March 12, 2015 |
| Fresenius Kabi USA, LLC | 1 | injection, solution | Generic drugs (ANDA) | April 1, 2009 |
| Gland Pharma Limited | 1 | injection | Generic drugs (ANDA) | November 18, 2019 |
| Hospira, Inc. | 1 | injection, solution | Generic drugs (ANDA) | February 27, 2008 |
| Ipsen Biopharmaceuticals, Inc. | 1 | injection, powder, for solution | New drug applications (NDA) | October 22, 2015 |
| Xiromed, LLC | 1 | injection | Generic drugs (ANDA) | November 18, 2019 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 15 | 65.2% |
| Injection | 7 | 30.4% |
| Injection, powder, for solution | 1 | 4.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 19 | 82.6% |
| New drug applications (NDA) | 4 | 17.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Topoisomerase Inhibitor | 23 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.