Data / Drug companies / Fidaxomicin
Fidaxomicin: 6 companies and 7 products in the FDA NDC directory
Fidaxomicin is listed in the FDA National Drug Code Directory by 6 companies, with 7 products in commercial distribution. 5 of the products (71.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; granule, for suspension; tablet, coated, and the newest product started marketing on October 7, 2026.
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- Companies listing it
- 6
- Products
- 7
- Generic (ANDA) products
- 5 (71.4%)
- Application numbers
- 7
- Routes
- Oral
- Brand names
- Dificid, Dificid
- openFDA record search
- api.fda.gov
Companies that list fidaxomicin
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Merck Sharp & Dohme LLC | 2 | granule, for suspension; tablet, film coated | New drug applications (NDA) | February 18, 2020 |
| Apotex Corp. | 1 | tablet, film coated | Generic drugs (ANDA) | February 3, 2026 |
| Hikma Pharmaceuticals USA Inc. | 1 | tablet, coated | Generic drugs (ANDA) | October 7, 2026 |
| Sandoz Inc | 1 | tablet, film coated | Generic drugs (ANDA) | August 27, 2026 |
| Teva Pharmaceuticals, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | July 15, 2025 |
| Torrent Pharmaceuticals Limited | 1 | tablet, film coated | Generic drugs (ANDA) | January 27, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 5 | 71.4% |
| Granule, for suspension | 1 | 14.3% |
| Tablet, coated | 1 | 14.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 5 | 71.4% |
| New drug applications (NDA) | 2 | 28.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Macrolide Antibacterial | 7 |
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.