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Ursodiol Ursosiol 300 mg Capsule, 180-count — NDC 43063-0871-93 package photo

Ursodiol Ursosiol 300 mg Capsule, 180-count

by PD-Rx Pharmaceuticals, Inc. · 180 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-93)
NDC 43063-0871-93
🏷️ FDA NDC (as labeled) 43063-871-93 billing pads the product segment with a zero
This package
Contains180-count Pack sizes3 compare ↓
Also comes in: 60 capsules 43063-0871-60 100 capsules 43063-0871-01
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 43063-871-93
Product NDC 43063-871
11-digit billing NDC 43063087193
NCPDP billing unit EA — each (per item)
RxCUI 858747
UNII 3D089V7L0K
UPC 0343063871010
Application # ANDA210707
SPL Set ID d89c9e1e-a115-4a01-9275-74d6cd8cf285
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-05-17
Route ORAL
Dosage form CAPSULE
Substance URSADIOL
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 43063-871-93 — a 5-3-2 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 product segment → 43063-0871-93. 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.

🏭 Manufacturer & labeler

LabelerPD-Rx Pharmaceuticals, Inc.
Application holderABHAI LLC
FDA applicationANDA210707 (ANDA)
Labeler code43063
First marketedMay 2018
Product typeHuman Prescription Drug
Portfolio832 products on file
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.

🩺 Clinical

Label name URSODIOL 300 MG CAPSULE Ingredient Ursodiol
📗 Our plain-language guide HelloPharmacist
  • Great question. Ursodiol capsules are an option when surgery is too risky — maybe because of age, other health conditions, or a sensitivity to general anesthesia — or if you'd simp...
  • Why did my doctor prescribe ursodiol capsules instead of just removing my gallbladder?
  • That depends on why you're taking it. For gallstone dissolution, most doctors aim for up to 2 years — but if there's no sign of progress after 12 months, the chance of it working b...
  • How long will I need to take this medication?
📖 Read our full Ursodiol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

💊 What it looks like

Color pink / white
ShapeCapsule
ImprintK237
Size22 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

💲 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 eachPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 60 capsules 100 capsules
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ursodiol 300 mg 50268-0797-15 AvPAK 50 capsules $0.416 — Availability likely —
Ursodiol 300 mg 72664-0217-01 VGYAAN 100 capsules $0.421 AB Availability likely —
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 AB Availability likely —
Ursodiol 300 mg 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 mgthis 43063-0871-93 PD-Rx 180 capsules — AB FDA listed —
Ursodiol 300 mg 51407-0754-01 Golden 100 capsules — — FDA listed —
Ursodiol 300 mg 64380-0844-04 Strides 30 capsules — — 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 —
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

🏛️
2018
On the market since
May 2018
📍
2026
Currently FDA-listed
8 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.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
43063-0871-01 100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01) 2018-07-26 Active
43063-0871-60 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-60) 2019-12-10 Active
43063-0871-93 You're viewing this 180 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-93) 2019-12-10 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 43063-0871-93?
NDC 43063-0871-93 is a 180-count package — 180 capsule in 1 bottle, plastic.
What is the difference between NDC 43063-0871-93 and NDC 43063-0871-60?
Both are Ursodiol Ursosiol 300 mg Capsule — the drug itself is identical. NDC 43063-0871-93 is the 180-count package, while NDC 43063-0871-60 is the 60 capsules package.
What NDC number is used to bill for this package of Ursodiol Ursosiol 300 mg Capsule?
Bill NDC 43063-0871-93 — the 11-digit billing format is 43063087193. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 43063-871-93, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43063-0871-93, written without dashes as 43063087193. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 43063-0871-93, the first segment (43063) is the labeler code FDA assigned to PD-Rx Pharmaceuticals, Inc.; the middle segment (0871) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (93) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by PD-Rx Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 capsules (43063-0871-60), 100 capsules (43063-0871-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
PD-Rx Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 82 words ▾

INDICATIONS AND USAGE 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. Safety of use of ursodiol capsules beyond 24 months is not established. Ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

⏱️ Dosage and Administration 139 words ▾

DOSAGE AND ADMINISTRATION Gallstone Dissolution The recommended dose for ursodiol capsules 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 capsules therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol capsules 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 capsules therapy, the likelihood of success is greatly reduced. Gallstone Prevention The recommended dosage of ursodiol capsules for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).

⛔ Contraindications 57 words ▾

CONTRAINDICATIONS Ursodiol capsules will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for ursodiol capsules therapy. Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for ursodiol capsules therapy.

Allergy to bile acids.

⚠️ Warnings 68 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 Ursodiol capsules until a clinical evaluation has been conducted.

🤒 Adverse Reactions ~2 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 8 - 10 mg/kg/day (N = 155) Placebo (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 600 mg (N = 322) Placebo (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)

🔄 Drug Interactions 81 words ▾

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

🤰 Pregnancy 153 words ▾

Pregnancy Category B 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 capsules 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.

🧒 Pediatric Use 16 words ▾

Pediatric Use The safety and effectiveness of ursodiol capsules in pediatric patients have not been established.

🧓 Geriatric Use 109 words ▾

Geriatric Use In worldwide clinical studies of ursodiol capsules, 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, patients greater than 56 years of age did not exhibit statistically significantly different complete dissolution rates from the younger population. No age-related differences in safety and effectiveness were found.

Other reported clinical experience has not identified differences in response in elderly and younger patients. However, small differences in efficacy and greater sensitivity of some elderly individuals taking ursodiol capsules cannot be ruled out. Therefore, it is recommended that dosing proceed with caution in this population.

🆘 Overdosage 79 words ▾

OVERDOSAGE Neither accidental nor intentional overdosing with ursodiol capsules have been reported. Doses of ursodiol capsules in the range of 16 - 20 mg/kg/day have been tolerated for 6 to 37 months without symptoms by 7 patients. The LD 50 for ursodiol in rats is over 5000 mg/kg given over 7 to 10 days and over 7500 mg/kg for mice.

The most likely manifestation of severe overdose with ursodiol capsules would probably be diarrhea, which should be treated symptomatically.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY About 90% of a therapeutic dose of ursodiol capsules 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.

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 fall…

📦 How Supplied / Storage and Handling 90 words ▾

HOW SUPPLIED Ursodiol Capsules, USP are pink opaque cap, white opaque body with black imprint “K237” on both cap and body containing white to off-white powder. NDC 43063-871-60 Bottles of 60 NDC 43063-871-01 Bottles of 100 NDC 43063-871-93 Bottles of 180 Store at 20 to 25°C (68 to 77°F); excursions permitted within 15 o to 30 o C (59 o to 86 o F). [see USP Controlled Room Temperature]. Dispense in tight container (USP).

Keep out of reach of children. For all medical inquiries contact: KVK-Tech, Inc. Customer Service 1-215-579-1842

📋 Description 159 words ▾

DESCRIPTION Ursodiol Capsules, USP is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol, USP is ursodeoxycholic acid, 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: Colloidal silicon dioxide, corn starch and magnesium stearate.

Gelatin capsules contain red iron oxide, gelatin, and titanium dioxide. The capsules are printed with edible ink containing shellac, black iron oxide, propylene glycol, FD&C Blue # 2 aluminum lake, FD&C Red # 40 aluminum lake, D&C Yellow # 10 aluminum lake and FD&C Blue # 1 aluminum lake. chemical structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43063-0870-02 · PD-Rx 43063-0872-06 · PD-Rx →
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.