ursodiol

Drug ingredient

CAS 128-13-2

This chemical is an active pharmaceutical ingredient used in FDA-regulated drugs.

US productionNot reported

Import value, 2024$81M

Top sourceChina 35%

This chemical is not on EPA’s Toxic Substances Control Act inventory, the list behind EPA’s production survey.

Why supply is unknown

Production is reported production, not a complete census of factories. Import value and source-country shares describe a shared customs category, not a separate chemical measurement.

Where It Comes From

Customs basis: HS 291819 · basket

These shares come from HS customs code 291819, which covers 96 tracked chemicals in total. They estimate the category's origin mix, not this chemical specifically.

Source Countries

Country of origin for US imports, from Census customs data (2024).

CN 35%ChinaIN 34%IndiaIT 9%ItalyDE 9%GermanyJP 4%Japan

Switzerland
Ukraine
Colombia
Taiwan
Belgium
Israel
Sweden
Hungary
Ireland
Slovakia

44 FDA-registered drug labelers

Actavis Pharma, Inc.

Alivus Life Sciences Limited

Allergan, Inc.

American Health Packaging

Amneal Pharmaceuticals NY LLC

Arch Pharmalabs Limited

Aurobindo Pharma Limited

AvKARE

AvPAK

BluePoint Laboratories

Bryant Ranch Prepack

Cardinal Health 107, LLC

Chartwell RX, LLC

Daewoong Bio Inc.

Darmerica, LLC

Dipharma Francis Srl

Endo USA, Inc.

Epic Pharma, LLC

Fagron Inc

FH2 Pharma LLC

Glenmark Pharmaceuticals Inc., USA

Golden State Medical Supply, Inc.

ICE SpA

Intra-Sana Laboratories

Kalchem International inc

Lannett Company, Inc.

Laurus Labs Limited

LETCO MEDICAL, LLC

LGM PHARMA SOLUTIONS, LLC

Major Pharmaceuticals

Medisca Inc.

NorthStar Rx LLC

PD-Rx Pharmaceuticals, Inc.

Professional Compounding Centers of America dba PCCA

PuraCap Laboratories, LLC

Shanghai Yuanxinyu Pharmaceutical Technology Co., Ltd.

Sichuan Hugcon Biotechnology Co. Ltd.

Sichuan Xieli Pharmaceutical Co., Ltd.

Spectrum Laboratory Products, Inc.

Strides Pharma Science Limited

Symbio Generrics India Private Limited, Plot No: 22H, Sy.No 34P & 35P, Apsez, Lalam Koduru, Rambilli, Visakhapatnam, Andhra Pradesh, India-531011

VGYAAN Pharmaceuticals LLC

Zydus Lifesciences Limited

Zydus Pharmaceuticals (USA) Inc.

Why It Matters

Sectors

Health

Downstream Uses

Appears in 7 drug and cosmetic product listings (FDA).

•Urso Forte
•Ursodiol
•Reltone 200 mg
•Ursodiol 200 mg
•Ursodiol 400 mg
•Reltone 400 mg
•Urso 250

FDA Shortage Status

Whether any manufacturer currently reports this drug as in shortage on the FDA Drug Shortages database. "Active Shortage" means at least one presentation has status "current."

No Shortage

Shortage History

Rows group FDA shortage filings by drug product. Each manufacturer makes its own FDA shortage filing, so one product can carry several reports at once: Available, Limited Availability, Unavailable or to be discontinued.

to be discontinued
Ursodiol Capsule
Shortage listed since April 6, 2026

See all current drug shortages

Chemical Identity

CAS128-13-2

PubChem CID31401

DTXSIDDTXSID6023731

FormulaC24H40O4

Mol. Weight392.6 g/mol

SMILESCC(CCC(=O)O)C1CCC2C1(CCC3C2C(CC4C3(CCC(C4)O)C)O)C

Data Sources

PubChem · compound 31401Retrieved 2026-04-07
FDA National Drug Code directoryRetrieved 2026-04-25
FDA Drug ShortagesRetrieved 2026-10-04
US Census international tradeReporting year: 2024 · Retrieved 2026-10-04

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Brief citations

ursodiol (CAS 128-13-2) https://chemicalindependence.com/chemical/128-13-2/ PubChem: 31401. Retrieved 2026-04-07. https://pubchem.ncbi.nlm.nih.gov/compound/31401 FDA National Drug Code directory: CAS 128-13-2. Retrieved 2026-04-25. https://open.fda.gov/data/ndc/ FDA Drug Shortages: CAS 128-13-2. Retrieved 2026-10-04. https://www.accessdata.fda.gov/scripts/drugshortages/ US Census international trade: HS 291819 for CAS 128-13-2. Reporting year: 2024. https://usatrade.census.gov/