Prescription medicine
Ursodiol Brand names: Urso, Reltone, Ursolign; first approved as Actigall
Ursodiol (Actigall) is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 28 generic labelers, and pharmacies paid $0.429 per ursodiol 300 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the ursodiol FDA label on DailyMed (effective July 31, 2023, Actavis Pharma, Inc.); the NDA 19594 record on Drugs@FDA; every ursodiol label on DailyMed.
Highlights of the record
FDA label of July 31, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageUrsodiol 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.
Forms and strengths
- 150 mg
- 200 mg
- 250 mg
- 300 mg
- 400 mg
- 500 mg
Capsule; film-coated tablet; tablet.
On the market
- Earliest approval on file
- December 31, 1987 Actigall, Teva Branded Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first March 14, 2000; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 30 of which 28 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.429 per capsule Ursodiol 300 mg capsule
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 21,659 through July 30, 2026
What is ursodiol used for?
From the label: indications and usageUrsodiol 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.
FDA pharmacologic class: Bile Acid.
Source: FDA drug label (Ursodiol), Actavis Pharma, Inc., effective July 31, 2023 (SPL set a061bb07-a85d-4b08-877f-ce02156f0de7), via openFDA; the full label on DailyMed
Is there a generic for ursodiol (Actigall)?
The FDA approved the first generic ursodiol on March 14, 2000. 22 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ursodiol from 28 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1987 earliest approval on file
- 2000 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ursodiol (Actigall)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.429 per Ursodiol 300 mg capsule, down 11% from $0.481 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ursodiol 300 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ursodiol 250 mg tablet | Generic | $0.450 per tablet | $13.49 | +32% |
| Ursodiol 300 mg capsule | Generic | $0.429 per capsule | $12.88 | -11% |
| Ursodiol 500 mg tablet | Generic | $0.647 per tablet | $19.41 | -16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is ursodiol in shortage?
No ursodiol presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated April 6, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Ursodiol, Capsule, 300 mg (NDC 64380-844-06) | Strides Pharma Inc. | To Be Discontinued | April 6, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the ursodiol label say about other medicines?
The ursodiol label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cholestyramine | drug interactions | Drug Interactions Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of ursodiol by reducing its absorption. |
| Colestipol | drug interactions | Drug Interactions Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of ursodiol by reducing its absorption. |
Source: FDA drug label (Ursodiol), Actavis Pharma, Inc., effective July 31, 2023 (SPL set a061bb07-a85d-4b08-877f-ce02156f0de7), via openFDA; the full label on DailyMed
What do FAERS reports show for ursodiol?
The FDA Adverse Event Reporting System holds 21,659 reports that list ursodiol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,988 are coded as a death and 9,894 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other bile acids
- the pharmacologic class, with prices and generics
- Ursodiol side effects
- the label's list beside FAERS reports
- Ursodiol shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other