Quick answers
- What is Ursosiol used for?
- The FDA-approved label (Ursodiol, PD-Rx Pharmaceuticals, Inc., July 17, 2025) says: “Ursodiol Capsules are 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ursosiol have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ursosiol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ursosiol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ursosiol?
- 2 companies list prescription products of Ursosiol in the FDA NDC Directory, including KVK-Tech, Inc. and PD-Rx Pharmaceuticals, Inc..
What Ursosiol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ursodiol Capsules are 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. …
— FDA label: Ursodiol, PD-Rx Pharmaceuticals, Inc., effective July 17, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Ursodiol |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ursadiol 300 mg capsule | Generic | $0.4333 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- KVK-Tech, Inc.1 product
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA210707Abhai LLC · May 17, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 858747 |
|---|---|
| SPL set ID of the quoted label | d89c9e1e-a115-4a01-9275-74d6cd8cf285 |
| FDA labels (SPL) | 2 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | URSADIOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ursodiol, PD-Rx Pharmaceuticals, Inc., effective July 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →