FDA label
What is ursodiol used for?
The FDA-approved uses of ursodiol, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “• Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not ...”
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Ursodiol, capsule
Indications and Usage, quoted from the label by PuraCap Laboratories, LLC (ANDA075517). Cross-references to other label sections are left out.
- Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established.
- Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
Source: DailyMed label, set id 9d7f26d5-d8a9-4610-8d78-80ca3d442a79, version 6, effective December 19, 2024. NDC 24658-780, one of 27 listings for this product.
Ursodiol, tablet
Indications and Usage, quoted from the label by BluePoint Laboratories (ANDA090801). Cross-references to other label sections are left out.
Ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC).
Source: DailyMed label, set id a3c98080-0a4d-4a93-8dcb-02ab8533050b, version 4, effective July 14, 2026. NDC 68001-377, one of 11 listings for this product.
Ursodiol, tablet, film coated
Indications and Usage, quoted from the label by Par Health USA, LLC (ANDA202540). Cross-references to other label sections are left out.
Ursodiol tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC).
Source: DailyMed label, set id 1a3a8942-94d4-4292-bf74-0a67d92acb90, version 14, effective June 12, 2026. NDC 49884-412, one of 9 listings for this product.
Questions
What is ursodiol used for?
The FDA label says: “• Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not ...”
What drug class is ursodiol?
FDA lists ursodiol in the Bile Acid established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.