SPL Set ID: e7204052-02cf-4b38-835b-d8754c74b2cd
1 drug(s) with this SPL Set ID
Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is Isopropyl 2-[ p -( p -chlorobenzoyl)phenoxy]-2-methylpropanoate with the following structural formula: The molecular formula is C 20 H 21 Cl O 4 and the molecular weight is 360.83 g/mol. Fenofibrate, USP is practically insoluble in water, very soluble in methylene chloride and slightly soluble in alcohol. The melting point is 79°C to 82°C. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, crospovidone, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, talc and titanium dioxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, crospovidone, D&C Red #28, FD&C Blue #1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, talc and titanium dioxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, crospovidone, D&C Red #28, FD&C Red #40, gelatin, iron oxide yellow, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. structure