078-0627-51
Afinitor® DISPERZTM
(everolimus tablets for oral suspension)
TABLETS MUST BE DISPERSED IN WATER.
TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.
28 Tablets for Oral Suspension
Carton contains 4 individual blister cards of 7 tablets.
PRINCIPAL DISPLAY PANEL
Package Label – 5 mg
Rx Only NDC 0078-0628-51
Afinitor® DISPERZTM
(everolimus tablets for oral suspension)
TALETS MUST BE DISPERSED IN WATER.
TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.
28 Tablets for Oral Suspension
Carton contains 4 individual blister cards of 7 tablets.
AFINITOR
everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0566
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)
CROSPOVIDONE (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to slightly yellow) Score no score
Shape OVAL (elongated with a bevelled edge) Size 12mm
Flavor Imprint Code 5;NVR
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0566-51 28 in 1 CARTON
1 NDC:0078-0566-61 1 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022334 03/31/2009
AFINITOR
everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0567
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G) EVEROLIMUS 10 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CROSPOVIDONE (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to slightly yellow) Score no score
Shape OVAL (elongated with a bevelled edge) Size 15mm
Flavor Imprint Code UHE;NVR
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0567-51 28 in 1 CARTON
1 NDC:0078-0567-61 1 in 1 BLISTER PACK
Marketing Information
Marketing Category Applicati |
