SPL Set ID: 2e799e93-b5a0-40f7-95c5-b40d8a948a0d

1 drug(s) with this SPL Set ID

Open DailyMed details

Ursodiol URSODIOL
300 mg
LANNETT COMPANY, INC. FDA Rx Only

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 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,7 β -dihydroxy-5 β -cholan-24-oic acid (C 24 H 40 O 4 ). 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. Chemical Structure

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