SPL Set ID: d59e9ea4-09ea-47bd-af2f-39f7a2e2aceb

1 drug(s) with this SPL Set ID

Open DailyMed details

ENTECAVIR ENTECAVIR
0.5 mg Tablet
CIPLA USA INC. FDA Rx Only

Entecavir, 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]-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 film-coated tablets USP 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: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet coating contains titanium dioxide, hypromellose, polyethylene glycol and iron oxide red (1 mg tablet only). image

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