NDC Code(s) : 62856-796-01, 62856-796-04
Packager : Eisai Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AKYNZEONetupitant and Palonosetron CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-796
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NETUPITANT(UNII: 7732P08TIR)
(NETUPITANT - UNII:7732P08TIR) 		NETUPITANT300 mg
PALONOSETRON(UNII: 5D06587D6R)
(PALONOSETRON - UNII:5D06587D6R) 		PALONOSETRON0.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SUCROSE LAURATE(UNII: 05Q7CD0E49)
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(UNII: U72Q2I8C85)
GLYCERIN(UNII: PDC6A3C0OX)
POLYGLYCERYL-3 DIOLEATE(UNII: D08AL46IU2)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
GELATIN(UNII: 2G86QN327L)
SORBITOL(UNII: 506T60A25R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color WHITE (White body), BROWN (Caramel cap) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code HE1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-796-011 in 1 CARTON 13/10/2014
11 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:62856-796-042 in 1 CARTON 13/10/2014
22 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 NDA205718 10/13/2014 05/31/2018

PRINCIPAL DISPLAY PANEL

Principal Display Panel
NDC 62856-796-01
Akynzeo
(netupitant and palonosetron)
capsules, 300mg/0.5mg

NDC 62856-796-01 Akynzeo (netupitant and palonosetron) capsules, 300mg/0.5mg

PRINCIPAL DISPLAY PANEL

Principal Display Panel
NDC 62856-796-01
Akynzeo
(netupitant and palonosetron)
capsules, 300mg/0.5mg

NDC 62856-796-01 Akynzeo (netupitant and palonosetron) capsules, 300mg/0.5mg

PRINCIPAL DISPLAY PANEL

Principal Display Panel
NDC 62856-796-04
Akynzeo
(netupitant and palonosetron)
capsules, 300mg/0.5mg
For Hospital Use Only

NDC 62856-796-04 Akynzeo (netupitant and palonosetron) capsules, 300mg/0.5mg

PRINCIPAL DISPLAY PANEL

Principal Display Panel
NDC 62856-796-04
Akynzeo
(netupitant and palonosetron)
capsules, 300mg/0.5mg
For Hospital Use Only

NDC 62856-796-04 Akynzeo (netupitant and palonosetron) capsules, 300mg/0.5mg