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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, 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 (C24H40O4). Ursodiol USP has a molecular weight of 392.58. Its structure is shown below:
Inactive Ingredients. Pregelatinized Starch, Colloidal Silicon Dioxide, Magnesium Stearate. The capsule shell consists of FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, Titanium Dioxide, and Gelatin. The capsule imprinting ink consists of Shellac Glaze in Ethanol, Black Iron Oxide, N-Butyl Alcohol, Propylene Glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake, Ethanol, and Methanol.