SPL Set ID: 81b798dc-b8dc-48a5-af46-82bb55f789a8

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 a White to light brown or yellow crystals or crystalline powder. It is practically insoluble in Ethanol, slightly soluble in 0.1 mol/L Hydrochloric acid. It has a molecular weight of 213.19 and a molecular formula of C 9 H 11 NO 5 . Droxidopa capsules also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol and pregelatinized starch. The capsule shell is printed with black ink. The black inks contain black iron oxide, potassium hydroxide, propylene glycol, Shellac. The capsule shell contains the following inactive ingredients: 100 mg – FD&C Blue No. 1, gelatin, FD&C Red 40 and titanium dioxide; 200 mg – ferric oxide yellow, gelatin and titanium dioxide; 300 mg – FD&C Blue No. 1, D & C Yellow 10, gelatin and titanium dioxide. Droxidopa capsules differ in size and color by strength [ see Dosage Forms and Strengths ( 3 ) ]. Image-01