SPL Set ID: f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2

1 drug(s) with this SPL Set ID

Open DailyMed details

Isturisa OSILODROSTAT
RECORDATI RARE DISEASES, INC. FDA Rx Only

ISTURISA (osilodrostat) is a cortisol synthesis inhibitor. The chemical name of osilodrostat is 4-[(5 R )-6,7-Dihydro-5 H -pyrrolo[1,2- c ]imidazol-5-yl]-3-fluorobenzonitrile dihydrogen phosphate. Molecular formula of osilodrostat salt (phosphate) form on anhydrous basis is: (C 13 H 11 FN 3 ) (H 2 PO 4 ). Relative molecular mass of osilodrostat phosphate salt form is 325.24 g/mol. ISTURISA tablets for oral administration contains 1 mg or 5 mg of osilodrostat equivalent to 1.4 mg or 7.2 mg of osilodrostat phosphate respectively, and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, and magnesium stearate. The film coat is composed of hypromellose, titanium dioxide, ferric oxide (yellow), ferric oxide (red) (1 mg only), polyethylene glycol 4000, and talc. Chemical Structure

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