SPL Set ID: 0be6a394-cd10-42fc-97cf-ad53d81d8d93
1 drug(s) with this SPL Set ID
Each phenoxybenzamine hydrochloride capsule, USP with red cap and body, is imprinted with “Amneal” on cap and “1502” on body, and contains 10 mg of phenoxybenzamine hydrochloride, USP. Inactive ingredients consist of colloidal silicon dioxide, D&C red 33, FD & C red 3, gelatin, iron oxide yellow, lactose monohydrate and sodium lauryl sulfate. The capsule is imprinted with white pharmaceutical ink which contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide. Phenoxybenzamine hydrochloride is chemically known as N-(2-Chloroethyl)-N-(1-methyl-2-phenoxyethyl) benzylamine hydrochloride. Its molecular formula is C 18 H 22 ClNO·HCl. The chemical structure is: Phenoxybenzamine hydrochloride, USP is a white to almost white crystalline powder with a molecular weight of 340.29 g/mol, which melts between 136° and 141°C. It is freely soluble in ethanol (96%) and insoluble in diethyl ether. FDA approved organic impurity specification differs from the USP. 1