Quick answers
- What is Ursodiol used for?
- The FDA-approved label (Urso 250, Allergan, Inc., January 12, 2023) says: “URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC). URSO 250 and URSO Forte (ursodiol) tablets are bile acids indicated for the treatment of patients with primary biliary cholangitis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ursodiol have a boxed warning?
- No. None of the 41 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ursodiol?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated April 6, 2026). Ask your pharmacist about alternatives.
- Has Ursodiol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ursodiol?
- 28 companies list prescription products of Ursodiol in the FDA NDC Directory, including Bryant Ranch Prepack, Zydus Lifesciences Limited and Strides Pharma Science Limited.
What Ursodiol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC). URSO 250 and URSO Forte (ursodiol) tablets are bile acids indicated for the treatment of patients with primary biliary cholangitis.
— FDA label: Urso 250, Allergan, Inc., effective January 12, 2023. Read the full label on DailyMed →
The FDA has 41 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 41 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 51 in the FDA NDC Directory |
| Brand names | Reltone 200 Mg, Ursolign, Urso Forte, Reltone 400 Mg, Urso 250 |
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 |
|---|---|---|
| ursodiol 250 mg tablet | Generic | $0.4463 per tablet |
| ursodiol 250 mg tablet, film coated | Generic | $0.4463 per tablet |
| ursodiol 300 mg capsule | Generic | $0.4333 per capsule |
| ursodiol 500 mg tablet | Generic | $0.6513 per tablet |
| ursodiol 500 mg tablet, film coated | Generic | $0.6513 per tablet |
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.
- Bryant Ranch Prepack6 products
- Zydus Lifesciences Limited3 products
- Strides Pharma Science Limited3 products
- Zydus Pharmaceuticals USA Inc.3 products
- FH2 Pharma LLC2 products
- AvKARE2 products
- Par Health USA, LLC2 products
- Major Pharmaceuticals2 products
- AvPAK2 products
- BluePoint Laboratories2 products
- LGM Pharma Solutions, LLC2 products
- PuraCap Laboratories LLC2 products
- American Health Packaging2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Intra-Sana Laboratories2 products
- Allergan, Inc.2 products
- Chartwell RX, LLC1 product
- Aurobindo Pharma Limited1 product
- NorthStar Rx LLC1 product
- Golden State Medical Supply, Inc.1 product
- Actavis Pharma, Inc.1 product
- Pangea Pharmaceuticals, LLC1 product
- VGYAAN Pharmaceuticals LLC1 product
- Laurus Labs Limited1 product
- Epic Pharma, LLC1 product
- Lannett Company, Inc.1 product
- Amneal Pharmaceuticals NY LLC1 product
- Cardinal Health 107, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019594 ACTIGALL | Teva Branded Pharm | December 31, 1987 | 21, latest July 19, 2023 2023: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA020675 URSO 250, URSO FORTE | Abbvie | December 10, 1997 | 17, latest January 12, 2023 2023: Labeling · 2021: Labeling · 2013: Manufacturing (CMC) |
Generic approvals (14)
- ANDA075517Epic Pharma · March 14, 2000
- ANDA079082Lannett Co Inc · December 15, 2008
- ANDA090801Glenmark Pharms Ltd · July 12, 2011
- ANDA202540Ph Health · February 14, 2013
- ANDA211301Amneal Pharms Co · October 16, 2018
- ANDA211145Zydus Lifesciences · October 30, 2018
- ANDA213200Rising · February 12, 2020
- ANDA205789Lgm Pharma · May 8, 2020
- ANDA213555Chartwell Rx · August 17, 2020
- ANDA213504Strides Pharma · August 20, 2020
- ANDA214295Zydus Lifesciences · October 16, 2020
- ANDA210344Strides Pharma · January 22, 2021
- ANDA214329Pharmazone · July 28, 2021
- ANDA214849Aurobindo Pharma Ltd · November 28, 2022
Shortage status
To be discontinued · updated April 6, 2026 · first posted April 6, 2026
| Product | Ursodiol, Capsule, 300 mg (NDC 64380-844-06) |
|---|---|
| Company | Strides Pharma Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Urso 250, Allergan, Inc., effective January 12, 2023; 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 →