SPL Set ID: 0ce4eb7b-fa50-441d-ae71-eb33dca27926

1 drug(s) with this SPL Set ID

Open DailyMed details

Vardenafil VARDENAFIL
10 mg Tablet
ALEMBIC PHARMACEUTICALS INC. FDA Rx Only

Vardenafil hydrochloride orally disintegrating tablets, USP are an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific PDE5. Vardenafil HCl, USP is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula: Vardenafil HCl, USP is a white or slightly brown or yellow powder with a molecular weight of 579.1. It is slightly soluble in water, freely soluble in anhydrous Ethanol. Practically insoluble in heptane. Vardenafil hydrochloride orally disintegrating tablets, USP are formulated as white to off white, round, orally disintegrating tablets. Each tablet contains 11.85 mg vardenafil hydrochloride, USP (in trihydrate form), which is equivalent to 10 mg vardenafil and the following inactive ingredients: lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide, aspartame, citric acid monohydrate, NAT Peppermint FL WONF SD #491, sodium stearyl fumarate and magnesium stearate. Structure

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