SPL Set ID: 9d7f26d5-d8a9-4610-8d78-80ca3d442a79

1 drug(s) with this SPL Set ID

Open DailyMed details

Ursodiol URSODIOL
300 mg
PURACAP LABORATORIES, LLC FDA Rx Only

Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol, USP (ursodeoxycholic acid), is 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 : Corn starch, magnesium stearate, silicon dioxide and the capsule shell contain the following ingredients, gelatin, titanium dioxide, D&C Red #28, FD&C Blue #1 and FD&C Red #40. The imprinting ink contains the following: black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, propylene glycol and shellac glaze. structural-formula

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