Data / Drug companies / Itraconazole
Itraconazole: 14 companies and 15 products in the FDA NDC directory
Itraconazole is listed in the FDA National Drug Code Directory by 14 companies, with 15 products in commercial distribution. 12 of the products (80.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; solution; capsule, coated pellets, and the newest product started marketing on February 3, 2025.
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- Companies listing it
- 14
- Products
- 15
- Generic (ANDA) products
- 12 (80.0%)
- Application numbers
- 9
- Routes
- Oral
- Brand names
- Tolsura, Sporanox
- openFDA record search
- api.fda.gov
Companies that list itraconazole
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Amneal Pharmaceuticals LLC | 2 | solution; capsule | Generic drugs (ANDA) | September 27, 2016 |
| Alembic Pharmaceuticals Inc. | 1 | capsule | Generic drugs (ANDA) | December 16, 2016 |
| Alembic Pharmaceuticals Limited | 1 | capsule | Generic drugs (ANDA) | December 16, 2016 |
| American Health Packaging | 1 | capsule | Generic drugs (ANDA) | May 2, 2017 |
| Ascend Laboratories, LLC | 1 | capsule, coated pellets | Generic drugs (ANDA) | June 12, 2017 |
| AvPAK | 1 | capsule | Generic drugs (ANDA) | March 23, 2018 |
| Camber Pharmaceuticals, Inc. | 1 | solution | Generic drugs (ANDA) | September 1, 2020 |
| Janssen Pharmaceuticals, Inc. | 1 | capsule | New drug applications (NDA) | September 11, 1992 |
| Mayne Pharma Inc. | 1 | capsule, gelatin coated | New drug applications (NDA) | December 11, 2018 |
| Natco Pharma USA LLC | 1 | solution | Generic drugs (ANDA) | April 25, 2022 |
| NorthStar Rx LLC | 1 | capsule, coated pellets | Generic drugs (ANDA) | September 1, 2017 |
| Patriot Pharmaceuticals | 1 | capsule | New drug applications (NDA) | February 1, 2005 |
| Rising Pharma Holdings, Inc. | 1 | capsule | Generic drugs (ANDA) | February 3, 2025 |
| Torrent Pharmaceuticals Limited | 1 | capsule | Generic drugs (ANDA) | August 24, 2018 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 9 | 60% |
| Solution | 3 | 20% |
| Capsule, coated pellets | 2 | 13.3% |
| Capsule, gelatin coated | 1 | 6.7% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 12 | 80% |
| New drug applications (NDA) | 3 | 20% |
Pharmacologic classes
| Class | Products |
|---|---|
| Azole Antifungal | 15 |
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.