Drug
Who makes darunavir ethanolate and cobicistat?
2 companies list darunavir ethanolate and cobicistat as a human prescription drug, including under the names PREZCOBIX, PREZCOBIX PED. Forms: tablet, film coated; tablet, for suspension. 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 darunavir ethanolate and cobicistat
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Janssen Pharmaceuticals, Inc. | tablet, film coated; tablet, for suspension | NDANDA205395, NDA220092 | 3 | 0 |
| International Medication Systems, Ltd.United States | tablet, film coated | NDANDA205395 | 1 | 3 |
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Common questions
- Who makes darunavir ethanolate and cobicistat?
- 2 companies list darunavir ethanolate and cobicistat as a human prescription drug in the openFDA NDC Directory, led by Janssen Pharmaceuticals, Inc., International Medication Systems, Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.