Drug
Who makes ursosiol?
2 companies list ursosiol as a human prescription drug, including under the names Ursodiol. Forms: capsule. 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 ursosiol
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| KVK-TECH, INC.United States | capsule | ANDAANDA210707 | 1 | 2 |
| PD-Rx Pharmaceuticals Inc.United States | capsule | ANDAANDA210707 | 1 | 1 |
Enquiry
Common questions
- Who makes ursosiol?
- 2 companies list ursosiol as a human prescription drug in the openFDA NDC Directory, led by KVK-TECH, INC., PD-Rx Pharmaceuticals 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 ursosiol?
- 2 companies list ursosiol under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.