SPL Set ID: 01ec50a1-6c6c-46f0-8c74-73542b0a59c3

1 drug(s) with this SPL Set ID

Open DailyMed details

Entecavir ENTECAVIR
0.5 mg Tablet
CAMBER PHARMACEUTICALS, INC. FDA Rx Only

Entecavir tablet USP, is a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-Amino-1,9-dihydro-9-[(1S, 3R, 4S)-4­-hydroxy-3-(Hydroxymethyl)-2-methylenecyclopentyl]-6H-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 295.29. Entecavir has the following structural formula: Entecavir USP is an off-white to white color powder. It is soluble in dimethyl sulfoxide. Entecavir film-coated tablets are available for oral administration in strengths of 0.5 mg and 1 mg of entecavir. Entecavir 0.5 mg and 1 mg film-coated tablets contain the following inactive ingredients: calcium carbonate, carboxymethyl cellulose sodium, citric acid monohydrate, pregelatinized starch, sodium stearyl fumarate and soy polysaccharides. The tablet coating contains hypromellose, iron oxide red (1 mg tablet only), polyethylene glycol, polysorbate 80 (0.5 mg tablet only) and titanium dioxide. Fig1.jpg

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