Data / Drug companies / Doxorubicin hydrochloride
Doxorubicin hydrochloride: 20 companies and 62 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Doxorubicin hydrochloride is listed in the FDA National Drug Code Directory by 20 companies, with 62 products in commercial distribution. 47 of the products (75.8%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; injection, suspension, liposomal; injectable, liposomal, and the newest product started marketing on October 5, 2026.
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- Companies listing it
- 20
- Products
- 62
- Generic (ANDA) products
- 47 (75.8%)
- Application numbers
- 16
- Routes
- Intravenous, Intravitreal
- Brand names
- Doxil
- openFDA record search
- api.fda.gov
Companies that list doxorubicin hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 10 | injection, solution; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | January 19, 2018 |
| Pfizer Laboratories Div Pfizer Inc | 10 | injection, solution | New drug applications (NDA) | March 31, 2025 |
| BluePoint Laboratories | 7 | injectable, liposomal; injection, suspension, liposomal | Generic drugs (ANDA) | October 5, 2026 |
| Baxter Healthcare Corporation | 5 | injection, suspension, liposomal | New drug applications (NDA) | August 26, 2024 |
| Gland Pharma Limited | 3 | injection, solution | Generic drugs (ANDA) | August 22, 2017 |
| Alembic Pharmaceuticals Inc. | 2 | injection, suspension, liposomal | Generic drugs (ANDA) | June 27, 2025 |
| Alembic Pharmaceuticals Limited | 2 | injection, suspension, liposomal | Generic drugs (ANDA) | June 27, 2025 |
| Dr. Reddy's Laboratories Inc. | 2 | injection, suspension, liposomal | Generic drugs (ANDA) | June 27, 2025 |
| Fresenius Kabi USA, LLC | 2 | injection, solution | Generic drugs (ANDA) | June 14, 2000 |
| Lupin Pharmaceuticals, Inc. | 2 | injection, suspension, liposomal | Generic drugs (ANDA) | August 26, 2024 |
| NorthStar RxLLC | 2 | injectable, liposomal | Generic drugs (ANDA) | May 29, 2019 |
| Qilu Pharmaceutical Co., Ltd. | 2 | injection, suspension, liposomal | Generic drugs (ANDA) | February 3, 2026 |
| Sagent Pharmaceuticals | 2 | injection, suspension, liposomal; injection, solution | Generic drugs (ANDA) | March 1, 2026 |
| Sun Pharmaceutical Industries, Inc. | 2 | injection, solution | Generic drugs (ANDA) | February 20, 2012 |
| Sun Pharmaceutical Industries, Inc. | 2 | injectable, liposomal | Generic drugs (ANDA) | February 5, 2013 |
| Zydus Lifesciences Limited | 2 | injectable, liposomal | Generic drugs (ANDA) | September 14, 2020 |
| Zydus Pharmaceuticals USA Inc. | 2 | injectable, liposomal | Generic drugs (ANDA) | September 14, 2020 |
| Actavis Pharma, Inc. | 1 | injection, solution | Generic drugs (ANDA) | November 1, 2014 |
| Amneal Pharmaceuticals LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | February 17, 2017 |
| Mylan Institutional LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | February 27, 2014 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 27 | 43.5% |
| Injection, suspension, liposomal | 19 | 30.6% |
| Injectable, liposomal | 12 | 19.4% |
| Injection, powder, lyophilized, for solution | 4 | 6.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 47 | 75.8% |
| New drug applications (NDA) | 14 | 22.6% |
| Unapproved drugs for a shortage | 1 | 1.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Anthracycline Topoisomerase Inhibitor | 62 |
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.