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Ursodeoxycholic acid

Generic Name
Ursodeoxycholic acid
Brand Names
Reltone, Urso, Urso Forte
Drug Type
Small Molecule
Chemical Formula
C24H40O4
CAS Number
128-13-2
Unique Ingredient Identifier
724L30Y2QR

Overview

Ursodeoxycholic acid (UDCA), also known as ursodiol, is a naturally-occurring bile acid that constitutes a minor fraction of the human bile acid pool. UDCA has been used to treat liver disease for decades: its first use in traditional medicine dates back more than a hundred years. UDCA was first characterized in the bile of the Chinese black bear and is formed by 7b-epimerization of chenodeoxycholic acid, which is a primary bile acid. Due to its hydrophilicity, UDCA is less toxic than cholic acid or chenodeoxycholic acid. UDCA was first approved by the FDA in 1987 for dissolution of gallstones and for primary biliary cirrhosis in 1996. UDCA works by replacing the hydrophobic or more toxic bile acids from the bile acid pool.

Background

Ursodeoxycholic acid (UDCA), also known as ursodiol, is a naturally-occurring bile acid that constitutes a minor fraction of the human bile acid pool. UDCA has been used to treat liver disease for decades: its first use in traditional medicine dates back more than a hundred years. UDCA was first characterized in the bile of the Chinese black bear and is formed by 7b-epimerization of chenodeoxycholic acid, which is a primary bile acid. Due to its hydrophilicity, UDCA is less toxic than cholic acid or chenodeoxycholic acid. UDCA was first approved by the FDA in 1987 for dissolution of gallstones and for primary biliary cirrhosis in 1996. UDCA works by replacing the hydrophobic or more toxic bile acids from the bile acid pool.

Indication

Ursodeoxycholic acid is indicated for the treatment of patients with primary biliary cholangitis. It is used for the short-term treatment of radiolucent, noncalcified gallbladder stones in patients selected for elective cholecystectomy. It is also used to prevent gallstone formation in obese patients experiencing rapid weight loss.

Associated Conditions

  • Gallstones
  • Primary Biliary Cholangitis

FDA Approved Products

URSODIOL
Manufacturer:STAT RX USA LLC
Route:ORAL
Strength:300 mg in 1 1
Approved: 2010/06/14
NDC:16590-349
Urso Forte
Manufacturer:Allergan, Inc.
Route:ORAL
Strength:500 mg in 1 1
Approved: 2023/01/20
NDC:58914-790
Reltone 200 mg
Manufacturer:Intra-Sana Laboratories
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/01/16
NDC:80056-143
Ursodiol
Manufacturer:PuraCap Laboratories, LLC
Route:ORAL
Strength:300 mg in 1 1
Approved: 2016/12/15
NDC:24658-780
Ursodiol 400 mg
Manufacturer:LGM Pharma Solutions, LLC
Route:ORAL
Strength:400 mg in 1 1
Approved: 2020/08/13
NDC:79739-7144

Singapore Approved Products

No Singapore products found for this drug

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