SPL Set ID: 007a6ad8-4d23-4543-ae48-c651cac7dd7b
1 drug(s) with this SPL Set ID
Entecavir, USP is a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir, USP is 2-amino-1,9-dihydro-9-[( 1S,3R,4S )-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6 H -purin-6-one, monohydrate. Its molecular formula is C 12 H 15 N 5 O 3 •H 2 O, which corresponds to a molecular weight of 295.3. Entecavir has the following structural formula: Entecavir, USP is a white to off-white powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25° C ± 0.5° C. Entecavir, USP film-coated tablets are available for oral administration in strengths of 0.5 mg and 1 mg of entecavir, USP. Entecavir, USP 0.5 mg and 1 mg film-coated tablets contain the following inactive ingredients: Crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. The tablet coating contains hypromellose, iron oxide red (in 1 mg tablet only), polyethylene glycol 8,000 and titanium dioxide. Structural Formula