Data / Drug companies / Ursodiol

Ursodiol: 28 companies and 49 products in the FDA NDC directory

Ursodiol is listed in the FDA National Drug Code Directory by 28 companies, with 49 products in commercial distribution. 45 of the products (91.8%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; tablet; tablet, film coated, and the newest product started marketing on July 14, 2026.

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Companies listing it

28

Products

49

Generic (ANDA) products

45 (91.8%)

Application numbers

16

Routes

Oral

Brand names

Reltone 200 MG, Reltone 400 MG, Urso 250, Ursolign, Urso Forte

openFDA record search

api.fda.gov

Companies that list ursodiol

Ranked by number of products. Finished drugs in commercial distribution.

Dosage forms

Marketing categories

Pharmacologic classes

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.