NDC Code(s) : 62856-799-05
Packager : Eisai Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ALOXIpalonosetron hydrochloride CAPSULE, GELATIN COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-799
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALONOSETRON HYDROCHLORIDE(UNII: 23310D4I19)
(PALONOSETRON - UNII:5D06587D6R) 		PALONOSETRON0.5 mg
Inactive Ingredients
Ingredient Name Strength
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(UNII: U72Q2I8C85)
GLYCERIN(UNII: PDC6A3C0OX)
POLYGLYCERYL-3 DIOLEATE(UNII: D08AL46IU2)
WATER(UNII: 059QF0KO0R)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
Product Characteristics
Color WHITE (light beige opaque) Score no score
Shape OVAL Size 3 mm
Flavor Imprint Code AIO
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-799-055 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022233 08/22/2008

PRINCIPAL DISPLAY PANEL

Principal Display Panel
NDC 62856-799-05
Aloxi
palonosetron HCI capsules
0.5 mg
5 capsules

NDC 62856-799-05 Aloxi palonosetron HCI capsules 0.5 mg 5 capsules