SPL Set ID: 9374da6b-2eb6-4ea9-bafc-2464a563f5f3

1 drug(s) with this SPL Set ID

Open DailyMed details

Ketoconazole KETOCONAZOLE
ESJAY PHARMA LLC FDA Rx Only

Ketoconazole tablets USP is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch. Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine and has the following structural formula: Ketoconazole is a white to off white powder, freely soluble in dichloromethane, soluble in Methanol. Sparingly soluble in ethanol (96%), with a molecular weight of 531.43. FDA approved dissolution test specifications differ from USP. keto-struct

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