Isturisa (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Isturisa (osilodrostat) tablets, 1 mg label
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Isturisa (osilodrostat) tablets, 5 mg label
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Isturisa (osilodrostat) tablets, 10 mg label
(click image for full-size original)
ISTURISA osilodrostat tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55292-320
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSILODROSTAT PHOSPHATE (OSILODROSTAT) OSILODROSTAT 1 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MANNITOL
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 4000
TALC
Product Characteristics
Color yellow (PALE YELLOW) Score no score
Shape ROUND (ROUND, BICONVEX, BEVELED EDGE) Size 6mm
Flavor Imprint Code Y1;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55292-320-60 60 TABLET, COATED in 1 BLISTER PACK None
2 NDC:55292-320-20 20 TABLET, COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212801 03/31/2020
ISTURISA osilodrostat tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55292-321
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSILODROSTAT PHOSPHATE (OSILODROSTAT) OSILODROSTAT 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MANNITOL
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 4000
TALC
Product Characteristics
Color yellow Score no score
Shape ROUND (ROUND, BICONVEX, BEVELED EDGE) Size 7mm
Flavor Imprint Code Y2;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55292-321-60 60 TABLET, COATED in 1 BLISTER PACK None
2 NDC:55292-321-20 20 TABLET, COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212801 03/31/2020
ISTURISA osilodrostat tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55292-322
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSILODROSTAT PHOSPHATE (OSILODROSTAT) OSILODROSTAT 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MANNITOL
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL 4000
TALC
Product Characteristics
Color brown (PALE ORANGE BROWN) Score no score
Shape ROUND (ROUND, BICONVEX, BEVELED EDGE) Size 9mm
Flavor Imprint Code Y3;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55292-322-60 60 TABLET, COATED in 1 BLISTER PACK None
2 NDC:55292-322-20 20 TABLET, COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212801 03/31/2020
Labeler — Recordati Rare Diseases, Inc. (181699406)
Establishment
Name Address ID/FEI Operations
Novartis Pharma Stein AG 488152505 manufacture (55292-320), manufacture (55292-321), manufacture (55292-322), analysis (55292-320), analysis (55292-321), analysis (55292-322)

Revised: 03/2020 Recordati Rare Diseases, Inc.

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