SPL Set ID: af4f47e2-f556-40f2-a0fd-ff81e9f27429

1 drug(s) with this SPL Set ID

Open DailyMed details

Entecavir ENTECAVIR
0.5 mg Tablet
EPIC PHARMA, LLC FDA Rx Only

Entecavir 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 C12H15N5O3H2O, which corresponds to a molecular weight of 295.3. Entecavir has the following structural formula: Entecavir is a white to off-white powder. It is slightly soluble in water (3.158 mg/mL) at 37°C ± 0.5°C. Entecavir tablets, USP are available for oral administration in strengths of 0.5 mg and 1 mg of entecavir. Entecavir tablets 0.5 mg and 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, crospovidone, and magnesium stearate. The tablet coating contains titanium dioxide, hypromellose, polyethylene glycol, iron oxide black (1 mg tablet only) and iron oxide red (1 mg tablet only). Chemical Structure

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