Ursodiol 250 mg Tablet, Film Coated, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Bile Acid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Ursodiol is used to dissolve gallstones in people who do not want surgery or cannot have surgery to remove gallstones. Ursodiol is also used to prevent the formation of gallstones in overweight people who are losing weight very quickly. Ursodiol is used to treat people with primary biliary cholangitis (PBC; formerly known as a primary biliary cirrhosis; an autoimmune liver disease). Ursodiol is in a class of medications called gallstone dissolution agents. It works by decreasing the production of cholesterol and by dissolving the cholesterol in bile to prevent stone formation and by decreasing...
Read the full MedlinePlus article ↗- It's possible, but not guaranteed. Ursodiol capsules can dissolve certain types of gallstones — specifically small ones that are made of cholesterol and haven't become calcified. S...
- My doctor prescribed ursodiol capsules for my gallstones — does this mean I won't need surgery?
- Yes — your doctor will order liver function blood tests regularly while you're on the tablets. Expect checks every month for the first three months, then every six months after tha...
- I take ursodiol tablets for PBC. Do I need any special monitoring?
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Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII D9C330MD8B
Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII VH2XOU12IE
Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
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UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.6386 | $63.86 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ursodiol 250 mg 00904-6890-04 | Major | 1 tablet | $0.450 | AB | Availability likely | — |
| Ursodiol 250 mg 49884-0412-01 | Par | 100 tablets | $0.450 | AB | Availability likely | — |
| Ursodiol 250 mg 60687-0527-21 | American | 30 tablets | $0.450 | AB | Availability likely | — |
| Ursodiol 250 mg 64380-0918-06 | Strides | 100 tablets | $0.450 | AB | Availability likely | — |
| Ursodiol 250 mg 68001-0377-00 | BluePoint | 100 tablets | $0.450 | AB | Availability likely | — |
| Ursodiol 250 mg 68462-0473-01 | Glenmark | 100 tablets | $0.450 | AB | Availability likely | — |
| Ursodiol 250 mg 70710-1127-01 | Zydus | 100 tablets | $0.450 | AB | Availability likely | — |
| Ursodiol 250 mg 55154-2633-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Urso 250 250 mg 58914-0785-10 | Allergan, | 100 tablets | — | — | FDA listed | — |
| Ursodiol 250 mg 63629-2286-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Ursodiol 250 mg 70771-1407-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Ursodiol 250 mgthis 72162-1500-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72162-1500-01 You're viewing this | 100 TABLET, FILM COATED in 1 BOTTLE (72162-1500-1) | 2023-03-30 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Ursodiol Tablets, USP are indicated for the treatment of patients with primary biliary cirrhosis (PBC). Ursodiol tablets, USP are bile acids indicated for the treatment of patients with primary biliary cirrhosis ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended adult dosage: 13 to 15 mg/kg/day administered in two to four divided doses with food ( 2.1 ) Scored ursodiol 500 mg tablet: scored tablet can be broken in halves to provide recommended dosage ( 2.2 , 16.2 )
2.1General Dosing Information The recommended adult dosage for ursodiol in the treatment of PBC is 13 to 15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
2.2Liver Function Tests Liver Function Tests ( y- GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for the three months after start of therapy, and every six months thereafter [see Warnings and Precautions ( 5.1 ) ].
2.3Scoring the Ursodiol 500 mg Tablet The ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage. To break ursodiol 500 mg scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove).
Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How Supplied/Storage and Handling (16.2) ] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ursodiol 250 mg tablet Ursodiol 500 mg scored tablet Ursodiol 250 mg tablet ( 3 ) Ursodiol 500 mg scored tablet ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment. Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment ( 5 ). Liver function tests ( y -GT, alkaline phosphatase, AST, ALT) and bilirubin level should be monitored.
Treatment discontinuation should be considered if parameters increase to a level considered clinically significant in patients with stable historical liver function test levels ( 5 ). Caution should be exercised to maintain patient's bile flow ( 5 ).
5.1Abnormal Liver Function Tests Liver function tests ( y -GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter. This monitoring will allow the early detection of a possible deterioration of the hepatic function. Treatment discontinuation should be considered if the above parameters increase to a level considered clinically significant in patients with stable historical liver function test levels.
Caution has to be exercised to maintain the bile flow of the patients taking ursodiol.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions reported with the use of ursodiol during worldwide postmarketing and clinical experience (≥1%) are, in alphabetical order: abdominal discomfort, abdominal pain, alopecia, diarrhea, nausea, pruritus, and rash ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The following table summarizes the adverse reactions observed in two placebo-controlled clinical trials. ADVERSE REACTIONS VISIT AT 12 MONTHS VISIT AT 24 MONTHS UDCA n (%) Placebo n (%) UDCA n (%) Placebo n (%) Diarrhea --- --- 1 (1.32) --- Elevated creatinine --- --- 1 (1.32) --- Elevated blood glucose 1 (1.18) --- 1 (1.32) --- Leukopenia --- --- 2 (2.63) --- Peptic ulcer --- --- 1 (1.32) --- Skin rash --- --- 2 (2.63) --- Thrombocytopenia --- --- 1 (1.32) --- Note: Those adverse reactions occurring at the same or higher incidence in the placebo as in the UDCA group have been deleted from this table (this includes diarrhea and thrombocytopenia at 12 months, nausea/vomiting, fever and other toxicity).
UDCA = Ursodeoxycholic acid = Ursodiol In a randomized, cross-over study in sixty PBC patients, seven patients (11.6%) reported nine adverse reactions: abdominal pain and asthenia (1 patient), nausea (3 patients), dyspepsia (2 patients) and anorexia and esophagitis (1 patient each). One patient on the twice a day regimen (total dose 1,000 mg) withdrew due to nausea. All of these nine adverse reactions except esophagitis were observed with the twice a day regimen at a total daily dose of 1,000 mg or greater.
However, an adverse reaction may occur at any dose.
6.2Postmarketing Experience The following adverse reactions, presented by system organ class in alphabetical order, have been identified during postapproval use of ursodiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders: abdominal discomfort, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.
General disorders and administration site conditions: malaise, peripheral edema, pyrexia. Hepatobiliary disorders: jaundice (or aggravation of preexisting jaundice). Immune System Disorders: Drug hypersensitivity to include facial edema, urticaria, angioedema and laryngeal edema.
Abnormal Laboratory Tests: ALT increased, AST increased, blood alkaline phosphatase increased, blood bilirubin increased, y-GT increased, hepatic enzyme increased, liver function test abnormal, transaminases increased. Musculoskeletal and connective tissue disorders: myalgia Nervous system disorders: dizziness, headache. Respiratory, thoracic and mediastinal disorders: cough.
Skin and subcutaneous tissue disorder: alopecia, pruritus, rash.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Bile Acid Sequestering Agents: May interfere with the action of ursodiol by reducing its absorption ( 7.1 ) Aluminum-based Antacids: May interfere with the action of ursodiol by reducing its absorption ( 7.2 ) Drugs that alter the metabolism of lipids or induce cholestasis may interfere with the action of ursodiol ( 7.3 )
7.1Bile Acid Sequestering Agents Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of ursodiol by reducing its absorption.
7.2Aluminum-based Antacids Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with ursodiol in the same manner as the bile acid sequestering agents.
7.3Drugs Affecting Lipid Metabolism Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of ursodiol.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Category B. Reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. There are no adequate or well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
8.3Nursing Mothers It is not known whether ursodiol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mother.
8.4Pediatric Use The safety and effectiveness of ursodiol in pediatric patients have not been established.
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category B. Reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. There are no adequate or well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of ursodiol in pediatric patients have not been established.
🆘 Overdosage ▾
10 OVERDOSAGE There have been no reports of accidental or intentional overdosage with ursodiol. Single oral doses of ursodiol at 10 g/kg in mice and dogs, and 5 g/kg in rats were not lethal. A single oral dose of ursodiol at 1.5 g/kg was lethal in hamsters. Symptoms of acute toxicity were salivation and vomiting in dogs, and ataxia, dyspnea, ptosis, agonal convulsions and coma in hamsters.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ursodiol, a naturally occurring hydrophilic bile acid, derived from cholesterol, is present as a minor fraction of the total human bile acid pool. Oral administration of ursodiol increases this fraction in a dose related manner, to become the major biliary acid, replacing/displacing toxic concentrations of endogenous hydrophobic bile acids that tend to accumulate in cholestatic liver disease. In addition to the replacement and displacement of toxic bile acids, other mechanisms of action include cytoprotection of the injured bile duct epithelial cells (cholangiocytes) against toxic effects of bile acids, inhibition of apotosis of hepatocytes, immunomodulatory effects, and stimulation of bile secretion by hepatocytes and cholangiocytes.
12.2Pharmacodynamics Lithocholic acid, when administered chronically to animals, causes cholestatic liver injury that may lead to death from liver failure in certain species unable to form sulfate conjugates. Ursodiol is 7-dehydroxylated more slowly than chenodiol. For equimolar doses of ursodiol and chenodiol, steady state levels of lithocholic acid in biliary bile acids are lower during ursodiol administration than with chenodiol administration.
Humans and chimpanzees can sulfate lithocholic acid. Although liver injury has not been associated with ursodiol therapy, a reduced capacity to sulfate may exist in some individuals.
12.3Pharmacokinetics Ursodiol (UDCA) is normally present as a minor fraction of the total bile acids in humans (about 5%). Following oral administration, the majority of ursodiol is absorbed by passive diffusion and its absorption is incomplete. Once absorbed, ursodiol undergoes hepatic extraction to the extent of about 50% in the absence of liver disease.
As the severity of liver disease increases, the extent of extraction decreases. In the liver, ursodiol is conjugated with glycine or taurine, then secreted into bile. These conjugates of ursodiol are absorbed in the small intestine by passive and active mechanisms.
The conjugates can also be deconjugated in the ileum by intestinal enzymes, leading to the formation of free ursodiol that can be reabsorbed and reconjugated in the liver. Nonabsorbed ursodiol passes into the colon where it is mostly 7-dehydroxylated to lithocholic acid. Some ursodiol is epimerized to chenodiol (CDCA) via a 7-oxo intermediate.
Chenodiol also undergoes 7-dehydroxylation to form lithocholic acid. These metabolites are poorly soluble and excreted in the feces. A small portion of lithocholic acid is reabsorbed, conjugated in the liver with glycine, or taurine and sulfated at the 3 position.
The resulting sulfated lithocholic acid conjugates are excreted in bile and then lost in feces. In healthy subjects, at least 70% of ursodiol (unconjugated) is bound to plasma protein. No information is available on the binding of conjugated ursodiol to plasma protein in healthy subjects or PBC patients.
Its volume of distribution has not been determined, but is expected to be small since the drug is mostly distributed in the bile and small intestine. Ursodiol is excreted primarily in the feces. With treatment, urinary excretion increases, but remains less than 1% except in severe cholestatic liver disease.
During chronic administration of ursodiol, it becomes a major biliary and plasma bile acid. At a chronic dose of 13 to 15 mg/kg/day, ursodiol constitutes 30 to 50% of biliary and plasma bile acids.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Ursodiol, a naturally occurring hydrophilic bile acid, derived from cholesterol, is present as a minor fraction of the total human bile acid pool. Oral administration of ursodiol increases this fraction in a dose related manner, to become the major biliary acid, replacing/displacing toxic concentrations of endogenous hydrophobic bile acids that tend to accumulate in cholestatic liver disease. In addition to the replacement and displacement of toxic bile acids, other mechanisms of action include cytoprotection of the injured bile duct epithelial cells (cholangiocytes) against toxic effects of bile acids, inhibition of apotosis of hepatocytes, immunomodulatory effects, and stimulation of bile secretion by hepatocytes and cholangiocytes.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Ursodiol Tablet, USP 250 mg, dosage form is a white to off-white, modified capsule shaped, film-coated tablet, imprinted with “P” and “412” on one side and plain on the other side. (NDC 72162-1500-1) Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION Ursodiol Tablets, USP 250 mg are available as a film-coated tablet for oral administration. Ursodiol Tablets, USP 500 mg are available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears.
It is a bitter-tasting white powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water. The chemical name of ursodiol is 3α,7ß-dihydroxy-5ß-cholan-24-oic (C 24 H 40 O 4 ). Ursodiol has a molecular weight of 392.56.
Its structure is shown below. Inactive ingredients: caprylic/capric triglycerides, copovidone, hypromellose, microcrystalline cellulose, magnesium stearate, povidone, polydextrose, polyethylene glycol 3350, sodium starch glycolate type A and titanium dioxide. ursodiol-structure.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION
17.1Appropriate Treatments Patients with the following conditions should be instructed to receive appropriate management measures: variceal bleeding, hepatic encephalopathy, ascites, in need of an urgent liver transplant or hepatic function deterioration [see Warnings and Precautions (5) ] . Caution has to be exercised to maintain the bile flow of the patients taking ursodiol.
17.2Drug Interactions Patients should be informed that absorption of ursodiol may be reduced if they are taking bile acid sequestering agents, such as cholestyramine and colestipol, aluminum-based antacids, or drugs known to alter the metabolism of cholesterol [see Drug Interactions (7) ] . Rx Only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Product of Italy Mfg. by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam - 603 103.
Made in India from Active Pharmaceutical Ingredient made in Italy Mfg. Lic. No.: TN00002121 OS412-01-74-01 R03/17