SPL Set ID: 4251c764-7224-4f94-9de7-b6c76cb1f5cd
1 drug(s) with this SPL Set ID
The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C 17 H 14 Cl 2 F 2 N 2 O 3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160 o C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets are supplied as white to off-white, round tablets, debossed with “S” on one side and “500” on the other side. Each tablet contains 500 mcg of roflumilast. Each roflumilast tablet for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, copovidone, hydroxypropyl cellulose, and sodium stearyl fumarate. 1