Data / Drug companies / Hydroxyurea
Hydroxyurea: 14 companies and 21 products in the FDA NDC directory
Hydroxyurea is listed in the FDA National Drug Code Directory by 14 companies, with 21 products in commercial distribution. 10 of the products (47.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; tablet, film coated; solution, and the newest product started marketing on December 2, 2025.
SpecStream is the live web data engine for teams and agents. It reads the National Drug Code Directory that FDA publishes, and this page is that reading. Ask for the companies that make a drug, a class or a dosage form, with their headquarters, website and size added from the web, and new listings and discontinued products arrive in your sheet, CRM, Slack or agent as FDA posts them.
- Companies listing it
- 14
- Products
- 21
- Generic (ANDA) products
- 10 (47.6%)
- Application numbers
- 7
- Routes
- Oral
- Brand names
- Droxia, Siklos, Hydrea, Xromi
- openFDA record search
- api.fda.gov
Companies that list hydroxyurea
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| H2-Pharma, LLC | 4 | capsule | New drug applications (NDA) | June 1, 2009 |
| Waylis Therapeutics LLC | 4 | capsule | New drug applications (NDA) | September 11, 2025 |
| Medunik | 2 | tablet, film coated | New drug applications (NDA) | October 15, 2020 |
| American Health Packaging | 1 | capsule | Generic drugs (ANDA) | September 17, 2008 |
| AvKARE | 1 | capsule | Generic drugs (ANDA) | July 23, 2013 |
| Coupler LLC | 1 | capsule | Generic drugs (ANDA) | December 2, 2025 |
| Golden State Medical Supply, Inc. | 1 | capsule | Generic drugs (ANDA) | April 8, 2020 |
| Leading Pharma, LLC | 1 | capsule | Generic drugs (ANDA) | July 9, 2020 |
| Major Pharmaceuticals | 1 | capsule | Generic drugs (ANDA) | February 24, 1999 |
| Nova Laboratories, Ltd | 1 | solution | New drug applications (NDA) | April 4, 2024 |
| Par Health USA, LLC | 1 | capsule | Generic drugs (ANDA) | February 24, 1999 |
| Qilu Pharmaceutical Co., Ltd. | 1 | capsule | Generic drugs (ANDA) | March 6, 2024 |
| Somerset Therapeutics, LLC | 1 | capsule | Generic drugs (ANDA) | June 18, 2024 |
| Teva Pharmaceuticals USA, Inc. | 1 | capsule | Generic drugs (ANDA) | October 19, 1998 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 18 | 85.7% |
| Tablet, film coated | 2 | 9.5% |
| Solution | 1 | 4.8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 11 | 52.4% |
| Generic drugs (ANDA) | 10 | 47.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Antimetabolite | 21 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). 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.