SPL Set ID: aa3ce55a-1ea9-4b50-b682-6f25398bcc29

Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula: Droxidopa is white to light brown color powder. It is soluble in 1 N hydrochloric acid, slightly soluble in water and practically insoluble in ethanol (99.5 %). It has a molecular weight of 213.19 and a molecular formula of C 9 H 11 NO 5 . Droxidopa Capsules, 100 mg, 200 mg and 300 mg intended for oral administration contain 100 mg, 200 mg and 300 mg droxidopa and contains the following inactive ingredients: corn starch (botanical source: maize), mannitol, magnesium stearate and sodium lauryl sulphate. Each hard gelatin capsule shell contains gelatin, titanium dioxide and water. Additionally, each 100 mg capsule shell contains: FD&C blue #1 and FD&C Red#40; each 200 mg capsule shell contains: iron oxide black, iron oxide red and iron oxide yellow; and each 300 mg capsule shell contains FD&C blue #1 and iron oxide yellow. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients:, black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Image