NIB 60 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PRODUCT CHARACTERISTICS
Color yellow Score no score
Shape OVAL Size 11mm
Flavor Imprint Code XL;60
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42388-023-26 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/25/2016
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208692 04/25/2016
CABOMETYX
cabozantinib tablet
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42388-025
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
cabozantinib s-malate (UNII: DR7ST46X58) (CABOZANTINIB - UNII:1C39JW444G) CABOZANTINIB 40 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PRODUCT CHARACTERISTICS
Color yellow Score no score
Shape TRIANGLE Size 8mm
Flavor Imprint Code XL;40
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42388-025-26 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/25/2016
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208692 04/25/2016
CABOMETYX
cabozantinib tablet
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42388-024
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
cabozantinib s-malate (UNII: DR7ST46X58) (CABOZANTINIB - UNII:1C39JW444G) CABOZANTINIB 20 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE |
