SPL Set ID: 3e8acd31-bbc7-48d5-956d-6cb04cbdc96c

1 drug(s) with this SPL Set ID

Open DailyMed details

Pirfenidone Capsule, 267 mg PIRFENIDONE
MACLEODS PHARMACEUTICALS LIMITED FDA Rx Only

Pirfenidone belongs to the chemical class of pyridone. Pirfenidone capsules USP are available as a white to off-white hard gelatin capsule containing 267 mg of pirfenidone for oral administration. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contains pirfenidone and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized starch. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes ammonium hydroxide, iron oxide black, iron oxide brown, potassium hydroxide, propylene glycol, shellac. pirfenidone-str

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