SPL Set ID: 8ca926e0-4c3c-473f-9cd0-ff38032d6963

Oseltamivir phosphate, USP, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate, USP. In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone K-30, pregelatinized starch, stearic acid, and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 45 mg capsule shell contains black iron oxide, gelatin, and titanium dioxide. The 75 mg capsule shell contains black iron oxide, gelatin, titanium dioxide, and yellow iron oxide. Each capsule is printed with blue ink, which includes FD&C Blue No. 2 indigo carmine aluminum lake as the colorant, methanol, N-butyl alcohol, ethanol, shellac glaze, and titanium dioxide. Oseltamivir phosphate, USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]–Ethyl 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The chemical formula is C 16 H 28 N 2 O 4 (free base). The molecular weight is 312.40 g/mol for oseltamivir free base and 410.40 g/mol for oseltamivir phosphate salt. The structural formula is as follows: 1