SPL Set ID: 50958060-c904-4374-997d-59df54007fa4

1 drug(s) with this SPL Set ID

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Pirfenidone PIRFENIDONE
267 mg Tablet
AUROBINDO PHARMA LIMITED FDA Rx Only

Pirfenidone belongs to the chemical class of pyridone. Pirfenidone Tablets, USP are available as tablets containing 267 mg (yellow) and 801 mg (pink) pirfenidone, USP. 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, USP is a white to pale yellow, crystalline, non-hygroscopic powder. It is sparingly to slightly soluble in water, freely soluble in ethanol (96 %), slightly to very slightly soluble in n-Heptane. The melting point is approximately 109°C. Pirfenidone tablets, USP contain pirfenidone, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, and sodium stearyl fumarate. In addition, 267 mg tablets contains yellow iron oxide and 801 mg tablets contains red iron oxide. Chemical Structure

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