SPL Set ID: c51b80f3-a591-4db9-81b4-b91603e35d7c
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 molecular 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°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol and methanol, and soluble in N,N-Dimethyl formamide. Roflumilast Tablets are supplied as white to off-white, round, flat face bevel edged, uncoated tablets, debossed with “R” on one side and “0.25” or “0.5” on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast. Each tablet of Roflumilast Tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, polysorbate 80 and pregelatinised starch. roflumilast-structure