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Ursodiol

Metadata Updated: February 18, 2026

Ursodiol is a prescription medication available as 300 mg oral capsules, manufactured by Laurus Labs Limited under ANDA213200. It belongs to the bile acids and salts class and is used to treat certain liver conditions like gallstones and primary biliary cholangitis by helping dissolve cholesterol in bile. Packaged as 100 capsules per bottle (NDC 42385-946-01), it was approved for marketing in April 2021. This information was generated using AI and is provided for informational and research purposes only.

Access & Use Information

Public: This dataset is intended for public access and use. License: See this page for license information.

Downloads & Resources

Dates

Metadata Created Date February 18, 2026
Metadata Updated Date February 18, 2026
Data Update Frequency R/P1Y

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date February 18, 2026
Metadata Updated Date February 18, 2026
Publisher U.S. Food and Drug Administration
Maintainer
Identifier ANDA212452
Data First Published 2016-09-16
Data Last Modified 2025-03-17
Category FDA
Public Access Level public
Data Update Frequency R/P1Y
Bureau Code 009:10
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Harvest Object Id 4650199e-a823-4fd1-b879-fc00c5890051
Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
Harvest Source Title Healthdata.gov
Homepage URL https://www.fda.gov/drugs
License https://open.fda.gov/license
Program Code 009:002
Source Datajson Identifier True
Source Hash 9411600660e564152b5dba02c93d9ef218ed8943bd1fb9bdebb1720073299e6c
Source Schema Version 1.1

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