D0Z171K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CROSPOVIDONE (UNII: 68401960MK)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Product Characteristics
Color WHITE (white to slightly yellowish) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code D2;NVR
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0626-51 28 in 1 CARTON
1 NDC:0078-0626-61 1 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203985 08/29/2012
AFINITOR DISPERZ
everolimus tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0627
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G) EVEROLIMUS 3 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CROSPOVIDONE (UNII: 68401960MK)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Product Characteristics
Color WHITE (white to slightly yellowish) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code D3;NVR
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0627-51 28 in 1 CARTON
1 NDC:0078-0627-61 1 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203985 08/29/2012
AFINITOR DISPERZ
everolimus tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0628
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G) EVEROLIMUS 5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CROSPOVIDONE (UNII: 68401960MK)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP |
