Product Information

Description

Capecitabine, USP is a fluoropyrimidine  carbamate  with  antineoplastic  activity. It is an orally administered systemic prodrug of 5’-deoxy-5-fluorouridine (5’-DFUR) which is converted to 5-fluorouracil. The  chemical  name  for  capecitabine , USP is  5’-deoxy-5-fluoro-N-[(pentyloxy)  carbonyl]-cytidine  and  has  a molecular weight of 359.35. Capecitabine, USP has the following structural formula. Capecitabine, USP is a white to off-white crystalline powder. Freely soluble in methanol, soluble in acetonitrile and in ethanol. Sparingly soluble in water. Capecitabine tablets, USP are supplied as biconvex, oblong film-coated tablets for oral administration. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in capecitabine tablets, USP include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides.