TIVE MOIETY
Ingredient Name Basis of Strength Strength
LENVATINIB (UNII: EE083865G2) (LENVATINIB - UNII:EE083865G2) LENVATINIB 10 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
TALC (UNII: 7SEV7J4R1U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SHELLAC (UNII: 46N107B71O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PRODUCT CHARACTERISTICS
Color YELLOW (yellow body) , RED (yellowish-red cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code E;LENV;10;mg
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-710-30 6 in 1 BOX, UNIT-DOSE 02/13/2015
1 NDC:62856-710-05 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206947 02/13/2015
LENVIMA
lenvatinib kit
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-714
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-714-30 6 in 1 BOX 02/13/2015
1 NDC:62856-714-05 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 5
Part 2 5
Part 1 of 2
LENVATINIB
lenvatinib capsule
PRODUCT INFORMATION
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
LENVATINIB (UNII: EE083865G2) (LENVATINIB - UNII:EE083865G2) LENVATINIB 10 mg
PRODUCT CHARACTERISTICS
Color YELLOW (yellow body) , RED (yellowish-red cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code E;LENV;10;mg
Contains
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206947
Part 2 of 2
LENVATINIB
lenvatinib capsule
PRODUCT INFORMATION
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
LENVATINIB (UNII: EE083865G2) (LENVATINIB - UNII:EE083865G2) LENVATINIB 4 mg
PRODUCT CHARACTERISTICS
Color RED (yellowish-red cap and body) Score no score
Shape CAPSULE S |
