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Ursodiol 300 mg Capsule, 50-count — NDC 00904-6221-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ursodiol 300 mg Capsule, 50-count — NDC 0904-6221-06 (Billing 00904-6221-06)

by Major Pharmaceuticals · 50 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK

This is a package of 50 capsules of Ursodiol 300 mg Capsule from Major Pharmaceuticals, marketed since Apr 2011 and currently FDA-listed; retail pharmacies pay about $0.4292 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 00904-6221-06
🏷️ FDA NDC (as labeled) 0904-6221-06 billing pads the labeler segment with a zero
This package
Contains50-count Cost per ea$0.4292 NADAC Per package$21.46 / 50 capsule Pack sizes2 compare ↓
Also priced by: Part D plans $0.8106/unit — full pricing hub ↓
Main listing for product 0904-6221 · Also comes in: 100 capsules 0904-6221-61
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0904-6221-06 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0904 labeler · 6221 product · 06 package
Package marketed since
Apr 1, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
50 EA per package
Barcode (UPC-A, from the NDC)
3 0904622106 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0904-6221-06
Product NDC 0904-6221
11-digit billing NDC 00904622106
NCPDP billing unit EA — each (per item)
RxCUI 858747
UNII 724L30Y2QR
Application # ANDA075517
SPL Set ID c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7
Established class (EPC) Bile Acid
Chemical class Bile Acids and Salts
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-04-01
Route ORAL
Dosage form CAPSULE
Substance URSODIOL
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 52100040000120
GPI class Ursodiol
GCN Seq No 003095
GCN 01070
HICL code 001370
Ingredient (HICL) Ursodiol
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D7
Therapeutic class — intermediate (HIC2) Act Primarily On Liver/Biliary Tract
HIC3 code D7A
Therapeutic class — specific (HIC3) Bile Salts
AHFS code 56:14.00.00
AHFS class Cholelitholytic Agents
FDB label name URSODIOL 300 MG CAPSULE
FDB brand name Ursodiol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003095
  • GCN: 01070
  • GPI-14 (Medi-Span): 52100040000120
  • HICL (First Databank): 001370
  • AHFS class code: 56:14.00.00
  • RxCUI (RxNorm): 858747
Why two NDCs? The FDA registers this code as 0904-6221-06 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00904-6221-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Bile Acid class.

Pharmacologic class Bile Acid
Drug family (ATC) Bile acids and derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name URSODIOL 300 MG CAPSULE Ingredient Ursodiol
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Ursodiol capsules are used to dissolve certain cholesterol gallstones and to prevent gallstones during rapid weight loss. Urso 250, Urso Forte, and ursod...
  • It’s taken by mouth. For gallstones, capsules are usually divided into 2 or 3 doses a day. For PBC, tablets are taken in two to four divided doses with food. Follow your prescripti...
  • Stomach-related effects are the most common, such as belly pain, diarrhea, constipation, and nausea. Headache and dizziness can also happen. Call your doctor about severe belly pai...
  • Yes. Cholestyramine, colestipol, and aluminum-based antacids may reduce how much ursodiol works. Estrogens, birth control pills, and clofibrate can work against it for gallstones....
📖 Read our full Ursodiol guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.429 $21.46 / 50 capsule
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 $0.8106 $40.53 / 50 capsule
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Feb 2026 Sep 2026 $0.690 $0.416
▼ Down 28% over the last 22 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00904-6221-06 You're viewing this Main listing 50 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK $0.4292 / ea $21.46 2011-04-01 — Active
00904-6221-61 0904-6221-61 100 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK $0.4292 / ea $42.92 2011-04-01 — Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.4292 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 50-count package — 50 blister pack in 1 carton / 1 capsule in 1 blister pack.
How does this package differ from NDC 00904-6221-61?
Both are Ursodiol 300 mg Capsule — the drug itself is identical. This page's package is the 50-count one, while NDC 00904-6221-61 is the 100 capsules package.
What NDC number is used to bill for this package of Ursodiol 300 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ursodiol 300 mg 50268-0797-15 AvPAK 50 capsules $0.416 — Availability likely save 3%
Ursodiol 300 mg 72664-0217-01 VGYAAN 100 capsules $0.421 AB Availability likely save 2%
Ursodiol 300 mg 00527-1326-01 Lannett 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 00591-3159-01 Actavis 100 capsules $0.429 — Availability likely —
Ursodiol 300 mgthis 00904-6221-06 Major 50 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 10702-0237-01 KVK-Tech, 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 24658-0780-01 PuraCap 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 42385-0946-01 Laurus 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 42806-0503-01 Epic 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 59651-0421-01 Aurobindo 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 60687-0100-01 American 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 62135-0430-60 Chartwell 60 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 69238-1540-01 Amneal 100 capsules $0.429 — Availability likely —
Ursodiol 300 mg 70710-1483-01 Zydus 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 72603-0613-01 NorthStar 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 24658-0999-10 PuraCap 1000 capsules — AB FDA listed —
Ursodiol 300 mg 42291-0923-01 AvKARE 100 capsules — AB FDA listed —
Ursodiol 300 mg 43063-0871-01 PD-Rx 100 capsules — AB FDA listed —
Ursodiol 300 mg 51407-0754-01 Golden 100 capsules — AB FDA listed —
Ursodiol 300 mg 64380-0844-04 Strides 30 capsules — AB FDA listed —
Ursodiol 300 mg 70771-1524-01 Zydus 100 capsules — AB FDA listed —
Ursodiol 300 mg 72162-2168-01 Bryant 100 capsules — AB FDA listed —
Ursodiol 300 mg 72162-2619-01 Bryant 100 capsules — AB FDA listed —
Ursodiol 300 mg 50268-0864-13 AvPAK 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
On the market since
Apr 2011
📍
2026
Currently FDA-listed
15 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

🧪 Avoiding an ingredient? See Ursodiol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 6T47AS764T
    Red 40 Lake is a synthetic colorant made by combining Red 40 dye with aluminum hydroxide. It's used to give tablets, capsules, and other medicines a red or pink color for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • 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.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

15 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMajor Pharmaceuticals
Application holderEPIC PHARMA LLC
FDA applicationANDA075517 (ANDA)
Labeler code00904
First marketedApr 2011
Product typeHuman Prescription Drug
Portfolio630 products on file

More NDCs from Major Pharmaceuticals labeler code 00904

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🧬 Pharmacodynamics 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 81 words ▾

INDICATIONS AND USAGE 1. 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.

2. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

⏱️ Dosage and Administration 134 words ▾

DOSAGE AND ADMINISTRATION Gallstone Dissolution The recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8 - 10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months.

Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced. Gallstone Prevention The recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).

⛔ Contraindications 57 words ▾

CONTRAINDICATIONS 1. Ursodiol will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for ursodiol therapy.

2. Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for ursodiol therapy. 3.

Allergy to bile acids.

⚠️ Warnings 67 words ▾

Warnings Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis There have been rare postmarketing reports of ursodiol-treated patients who developed enteroliths (bezoars) resulting in obstructive symptoms that required surgical intervention. These patients had medical conditions that predisposed them to intestinal stenosis or stasis (e.g., surgical enteroanastomoses, Crohn's disease). If a patient presents with obstructive gastrointestinal symptoms, hold Actigall until a clinical evaluation has been conducted.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS The nature and frequency of adverse experiences were similar across all groups. The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level: GALLSTONE DISSOLUTION Ursodiol Placebo 8 - 10 mg/kg/day (N=155) (N=159) N (%) N (%) Body as a Whole Allergy 8 (5.2) 7 (4.4) Chest Pain 5 (3.2) 10 (6.3) Fatigue 7 (4.5) 8 (5.0) Infection Viral 30 (19.4) 41 (25.8) Digestive System Abdominal Pain 67 (43.2) 70 (44.0) Cholecystitis 8 (5.2) 7 (4.4) Constipation 15 (9.7) 14 (8.8) Diarrhea 42 (27.1) 34 (21.4) Dyspepsia 26 (16.8) 18 (11.3) Flatulence 12 (7.7) 12 (7.5) Gastrointestinal Disorder 6 (3.9) 8 (5.0) Nausea 22 (14.2) 27 (17.0) Vomiting 15 (9.7) 11 (6.9) Musculoskeletal System Arthralgia 12 (7.7) 24 (15.1) Arthritis 9 (5.8) 4 (2.5) Back Pain 11 (7.1) 18 (11.3) Myalgia 9 (5.8) 9 (5.7) Nervous System Headache 28 (18.1) 34 (21.4) Insomnia 3 (1.9) 8 (5.0) Respiratory System Bronchitis 10 (6.5) 6 (3.8) Coughing 11 (7.1) 7 (4.4) Pharyngitis 13 (8.4) 5 (3.1) Rhinitis 8 (5.2) 11 (6.9) Sinusitis 17 (11.0) 18 (11.3) Upper Respiratory Tract Infection 24 (15.5) 21 (13.2) Urogenital System Urinary Tract Infection 10 (6.5) 7 (4.4) GALLSTONE PREVENTION Ursodiol Placebo 600 mg (N=322) (N=325) N (%) N (%) Body as a Whole Fatigue 25 (7.8) 33 (10.2) Infection Viral 29 (9.0) 29 (8.9) Influenza-like Symptoms 21 (6.5) 19 (5.8) Digestive System Abdominal Pain 20 (6.2) 39 (12.0) Constipation 85 (26.4) 72 (22.2) Diarrhea 81 (25.2) 68 (20.9) Flatulence 15 (4.7) 24 (7.4) Nausea 56 (17.4) 43 (13.2) Vomiting 44 (13.7) 44 (13.5) Musculoskeletal System Back Pain 38 (11.8) 21 (6.5) Musculoskeletal Pain 19 (5.9) 15 (4.6) Nervous System Dizziness 53 (16.5) 42 (12.9) Headache 80 (24.8) 78 (24.0) Respiratory System Pharyngitis 10 (3.1) 19 (5.8) Sinusitis 17 (5.3) 18 (5.5) Upper Respiratory Tract Infection 40 (12.4) 35 (10.8) Skin and Appendages Alopecia 17 (5.3) 8 (2.5) Urogenital System Dysmenorrhea 18 (5.6) 19 (5.8)

🆘 Overdosage 76 words ▾

OVERDOSAGE Neither accidental nor intentional overdosing with ursodiol has been reported. Doses of ursodiol in the range of 16 - 20 mg/kg/day have been tolerated for 6 - 37 months without symptoms by 7 patients. The LD 50 for ursodiol in rats is over 5000 mg/kg given over 7 - 10 days and over 7500 mg/kg for mice. The most likely manifestation of severe overdose with ursodiol would probably be diarrhea, which should be treated symptomatically.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY About 90% of a therapeutic dose of ursodiol is absorbed in the small bowel after oral administration. After absorption, ursodiol enters the portal vein and undergoes efficient extraction from portal blood by the liver (i.e., there is a large “first-pass” effect) where it is conjugated with either glycine or taurine and is then secreted into the hepatic bile ducts. Ursodiol in bile is concentrated in the gallbladder and expelled into the duodenum in gallbladder bile via the cystic and common ducts by gallbladder contractions provoked by physiologic responses to eating.

Only small quantities of ursodiol appear in the systemic circulation and very small amounts are excreted into urine. The sites of the drug’s therapeutic actions are in the liver, bile, and gut lumen. Beyond conjugation, ursodiol is not altered or catabolized appreciably by the liver or intestinal mucosa.

A small proportion of orally administered drug undergoes bacterial degradation with each cycle of enterohepatic circulation. Ursodiol can be both oxidized and reduced at the 7-carbon, yielding either 7-keto-lithocholic acid or lithocholic acid, respectively. Further, there is some bacterially catalyzed deconjugation of glyco- and tauro-ursodeoxycholic acid in the small bowel.

Free ursodiol, 7-keto-lithocholic acid, and lithocholic acid are relatively insoluble in aqueous media and larger proportions of these compounds are lost from the distal gut into the feces. Reabsorbed free ursodiol is reconjugated by the liver. Eighty percent of lithocholic acid formed in the small bowel is excreted in the feces, but the 20% that is absorbed is sulfated at the 3-hydroxyl group in the liver to relatively insoluble lithocholyl conjugates which are excreted into bile and lost in feces.

Absorbed 7-keto-lithocholic acid is stereospecifically reduced in the liver to chenodiol. Lithocholic acid causes cholestatic liver injury and can cause death from liver failure in certain species unable to form sulfate conjugates. Lithocholic acid is formed by 7-dehydroxylation of the dihydroxy bile acids (ursodiol and chenodiol) in the gut lumen.

The 7-dehydroxylation reaction appears to be alpha-specific, i.e., chenodiol is more efficiently 7-dehydroxylated than ursodiol and, for equimolar doses of ursodiol and chenodiol, levels of lithocholic acid appearing in bile are lower with the former. Man has the capacity to sulfate lithocholic acid. Although liver injury has not been associated with ursodiol therapy, a reduced capacity to sulfate may exist in some individuals, but such a deficiency has not yet been clearly demonstrated.

📦 How Supplied / Storage and Handling 122 words ▾

HOW SUPPLIED Ursodiol Capsules USP, 300 mg are #0 capsules with a pink opaque cap, white opaque body, imprinted “Є503” in black ink on cap and body, filled with white powder. It is supplied in: Cartons of 50 capsules (10 capsules each blister pack x 5), NDC 0904-6221-06 Cartons of 100 capsules (10 capsules each blister pack x 10), NDC 0904-6221-61 Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP.

Keep out of reach of children. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Rev. 08-2023-00 MF503REV08/23 OE1105

📋 Description 168 words ▾

DESCRIPTION Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol, USP (ursodeoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water.

The chemical name for ursodiol is 3α, 7β-Dihydroxy-5β-cholan-24-oic acid (C 24 H 40 O 4 ). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below: Inactive Ingredients: Corn starch, magnesium stearate, silicon dioxide and the capsule shell contain the following ingredients, gelatin, titanium dioxide, D&C Red # 28, FD&C Blue # 1 and FD&C Red # 40.

The imprinting ink contains the following: black iron oxide, D&C Yellow # 10 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, propylene glycol and shellac glaze. structural-formula

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Liver Tests Ursodiol therapy has not been associated with liver damage. Lithocholic acid, a naturally occurring bile acid, is known to be a liver-toxic metabolite. This bile acid is formed in the gut from ursodiol less efficiently and in smaller amounts than that seen from chenodiol.

Lithocholic acid is detoxified in the liver by sulfation and, although man appears to be an efficient sulfater, it is possible that some patients may have a congenital or acquired deficiency in sulfation, thereby predisposing them to lithocholate-induced liver damage. Abnormalities in liver enzymes have not been associated with ursodiol therapy and, in fact, ursodiol has been shown to decrease liver enzyme levels in liver disease. However, patients given ursodiol should have SGOT (AST) and SGPT (ALT) measured at the initiation of therapy and thereafter as indicated by the particular clinical circumstances.

Drug Interactions Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of ursodiol by reducing its absorption. Aluminum-based antacids have been shown to absorb bile acids in vitro and may be expected to interfere with ursodiol in the same manner as the bile acid sequestering agents. 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility Ursodeoxycholic acid was tested in 2-year oral carcinogenicity studies in CD-1 mice and Sprague-Dawley rats at daily doses of 50, 250, and 1000 mg/kg/day. It was not tumorigenic in mice. In the rat study, it produced statistically significant dose-related increased incidences of pheochromocytomas of adrenal medulla in males (p=0.014, Peto trend test) and females (p=0.004, Peto trend test).

A 78-week rat study employing intrarectal instillation of lithocholic acid and tauro-deoxycholic acid, metabolites of ursodiol and chenodiol, has been conducted. These bile acids alone did not produce any tumors. A tumor-promoting effect of both metabolites was observed when they were co-administered with a carcinogenic agent.

Results of epidemiologic studies suggest that bile acids might be involved in the pathogenesis of human colon cancer in patients who had undergone a cholecystectomy, but direct evidence is lacking. Ursodiol is not mutagenic in the Ames test. Dietary administration of lithocholic acid to chickens is reported to cause hepatic adenomatous hyperplasia.

Pregnancy Reproduction studies have been performed in rats and rabbits with ursodiol doses up to 200-fold the therapeutic dose and have revealed no evidence of impaired fertility or harm to the fetus at doses of 20- to 100-fold the human dose in rats and at 5-fold the human dose (highest dose tested) in rabbits. Studies employing 100- to 200-fold the human dose in rats have shown some reduction in fertility rate and litter size. There have been no adequate and well-controlled studies of the use of ursodiol in pregnant women, but inadvertent exposure of 4 women to therapeutic doses of the drug in the first trimester of pregnancy during the ursodiol trials led to no evidence of effects on the fetus or newborn baby.

Although it seems unlikely, the possibility that ursodiol can cause fetal harm cannot be ruled out; hence, the drug is not recommended for use during pregnancy. Nursing 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 is administered to a nursing mother.

Pediatric Use The safety and effectiveness of ursodiol in pediatric patients have not been established. Geriatric Use In worldwide clinical studies of ursodiol, approximately 14% of subjects were over 65 years of age (approximately 3% were over 75 years old). In a subgroup analysis of existing clinical trials, patie… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 214 words ▾

Pharmacodynamics Ursodiol suppresses hepatic synthesis and secretion of cholesterol, and also inhibits intestinal absorption of cholesterol. It appears to have little inhibitory effect on synthesis and secretion into bile of endogenous bile acids, and does not appear to affect secretion of phospholipids into bile. With repeated dosing, bile ursodeoxycholic acid concentrations reach a steady state in about 3 weeks.

Although insoluble in aqueous media, cholesterol can be solubilized in at least two different ways in the presence of dihydroxy bile acids. In addition to solubilizing cholesterol in micelles, ursodiol acts by an apparently unique mechanism to cause dispersion of cholesterol as liquid crystals in aqueous media. Thus, even though administration of high doses (e.g., 15 - 18 mg/kg/day) does not result in a concentration of ursodiol higher than 60% of the total bile acid pool, ursodiol-rich bile effectively solubilizes cholesterol.

The overall effect of ursodiol is to increase the concentration level at which saturation of cholesterol occurs. The various actions of ursodiol combine to change the bile of patients with gallstones from cholesterol-precipitating to cholesterol-solubilizing, thus resulting in bile conducive to cholesterol stone dissolution. After ursodiol dosing is stopped, the concentration of the bile acid in bile falls exponentially, declining to about 5% - 10% of its steady state level in about 1 week.

📄 Package Label / Principal Display Panel 23 words ▾

Package/Label Display Panel MAJOR® NDC 0904-6221-61 Unit Dose Ursodiol Capsules, USP 300 mg 100 CAPSULES (10 x 10) Rx only 300mg carton label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ursodiol — the program that covers self-administered drugs. 18 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ursodiol. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.22M
Claims incl. refills
135.9K
Beneficiaries
83.7K
Spend / beneficiary
$229.71
Spend / claim
$141.44
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 00904-6172-50 · Major 00904-6255-49 · Major →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.