ISTURISA Film-coated tablet Ref.[10371] Active ingredients: Osilodrostat

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

ISTURISA (osilodrostat) is a cortisol synthesis inhibitor.

The chemical name of osilodrostat is 4-[(5R)-6,7-Dihydro-5Hpyrrolo[1,2c]imidazol-5-yl]-3-fluorobenzonitrile dihydrogen phosphate.

Molecular formula of osilodrostat salt (phosphate) form on anhydrous basis is: (C13H11FN3) (H2PO4). Relative molecular mass of osilodrostat phosphate salt form is 325.24 g/mol.

ISTURISA tablets for oral administration contains 1 mg, 5 mg, or 10 mg of osilodrostat equivalent to 1.4 mg, 7.2 mg, and 14.3 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 and 10 mg only), ferrosoferric oxide (10 mg only), polyethylene glycol 4000, and talc.

Dosage Forms and Strengths

ISTURISA is available as:

  • 1 mg tablets: Pale yellow, unscored, round, biconvex with beveled edge tablet, debossed “Y1” on one side and “NVR” on the other side.
  • 5 mg tablets: Yellow, unscored, round, biconvex with beveled edge tablet, debossed “Y2” on one side and “NVR” on the other side.
  • 10 mg tablets: Pale orange brown, unscored, round, biconvex with beveled edge tablet, debossed “Y3” on one side and “NVR” on the other side.
How Supplied

ISTURISA (osilodrostat) tablets are supplied as follows:

Tablet StrengthDescriptionPackage ConfigurationNDC No.
1 mg Pale yellow, unscored, round, biconvex with beveled edge tablet, debossed “Y1” on one side and “NVR” on the other side. Each carton contains 3 blister packs. Each blister pack contains 20 tablets. 55292-320-60
5 mg Yellow, unscored, round, biconvex with beveled edge tablet, debossed “Y2” on one side and “NVR” on the other side. 55292-321-60
10 mg Pale orange brown, unscored, round, biconvex with beveled edge tablet, debossed “Y3” on one side and “NVR” on the other side. 55292-322-60

Drugs

Drug Countries
ISTURISA Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States
 
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