SPL Set ID: 788f1fe3-d8a1-42cc-9280-07f842da34ea
1 drug(s) with this SPL Set ID
Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules USP (monohydrate/macrocrystals) is a hard gelatin capsule. Each capsule contains 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals USP and 75 mg of nitrofurantoin monohydrate USP. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following: The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate. The chemical structure is the following: Inactive Ingredients: Each capsule contains carbomer homopolymer (Type A), carbomer homopolymer (Type B), compressible sugar, corn starch, lactose monohydrate, magnesium stearate, povidone, talc. In addition, the empty hard gelatin capsule shells contain D&C Yellow 10, FD&C Blue 1, FD&C Red 40, gelatin, sodium lauryl sulfate, and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, titanium dioxide. FDA approved dissolution test specifications differ from USP. Nitrofurantoin Macrocrystals USP Structure Nitrofurantoin Monohydrate USP Structure