Drug
Who makes fidaxomicin?
5 companies list fidaxomicin as a human prescription drug, including under the names Dificid. Forms: granule, for suspension; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing fidaxomicin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Merck Sharp & Dohme Corp. | granule, for suspension; tablet, film coated | NDANDA201699, NDA213138 | 2 | 0 |
| Apotex Inc.Canada | tablet, film coated | ANDAANDA219559 | 1 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated | ANDAANDA208443 | 1 | 6 |
| Sandoz Industrial Products S.AAustria | tablet, film coated | ANDAANDA220465 | 1 | 5 |
| Torrent Pharma, Inc.India | tablet, film coated | ANDAANDA220374 | 1 | 5 |
Bulk ingredient listings
- Biocon Biologics LimitedIndia · 1 NDC
- BrightGene Bio-Medical Technology Co., Ltd.China · 1 NDC
- Concord Biotech LimitedIndia · 1 NDC
- North China Pharmaceutical Huasheng Co. Ltd.China · 1 NDC
- TAPI Hungary Industries Kft. · 1 NDC
Orange Book patents
10 unexpired patents list fidaxomicin as the active ingredient, expiring between Mar 2027 and Nov 2034. Application holder: CUBIST PHARMACEUTICALS LLC.
Enquiry
Common questions
- Who makes fidaxomicin?
- 5 companies list fidaxomicin as a human prescription drug in the openFDA NDC Directory, led by Merck Sharp & Dohme Corp., Apotex Inc., Teva Pharmaceutical Industries Ltd., Sandoz Industrial Products S.A, Torrent Pharma, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Dificid?
- 4 companies list fidaxomicin under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies fidaxomicin active ingredient?
- 5 companies list fidaxomicin as a bulk ingredient, including Biocon Biologics Limited, BrightGene Bio-Medical Technology Co., Ltd., Concord Biotech Limited, North China Pharmaceutical Huasheng Co. Ltd..