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Drug Information for URSODIOL CAPSULES, USP9380Rx only (TEVA Pharmaceuticals USA Inc): DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- ADVERSE REACTIONS
- HOW SUPPLIED
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Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration.
Ursodiol is ursodiol USP (ursodeoxycholic acid), 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 freely soluble in ethanol and glacial acetic acid; slightly soluble in chloroform; sparingly soluble in ether; and practically insoluble in water. The chemical name for ursodiol is 3a, 7ß-dihydroxy-5ß-cholan-24-oic acid (C24H40O4). Ursodiol USP has a molecular weight of 392.58. Its structural formula is shown below:
Inactive Ingredients: colloidal silicon dioxide, corn starch, D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake, FD&C blue No. 2 aluminum lake, FD&C red No. 40, FD&C red No. 40 aluminum lake, gelatin, magnesium stearate, pharmaceutical glaze (modified) in SD-45, propylene glycol, synthetic black iron oxide, and titanium dioxide. The imprinting ink may contain antifoam DC 1510 and soya lecithin.
- Drug Information Provided by National Library of Medicine (NLM).