C, Albuquerque, NM, USA or Pierre Fabre, Médicament Production, Idron, Aquitaine, France and Helsinn Birex
Pharmaceuticals, Dublin, Ireland
HELSINN, Mfd for Helsinn Healthcare SA, Switzerland
Eisai Inc., Distributed and marketed by Eisai Inc., Woodcliff Lake, NJ 07677 under license of Helsinn Healthcare SA, Switzerland
ALOXI® is a registered trademark of Helsinn Healthcare, SA, Lugano, Switzerland
©2013 Eisai Inc., Woodcliff Lake, NJ 07677 U.S.A. 201227 For more information, go to www.ALOXI.com.
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 09/201
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC 62856-797-01
Aloxi®
palonosetron HCl injection
0.25 mg/5 mL (0.05 mg/mL)
For intravenous injection only.
5 mL single-use sterile vial.
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 0.075 mg/1.5 mL Injection
NDC 62856-798-01
Rx only
Aloxi®
palonosetron HCl injection
0.075 mg/1.5 mL single-use vial
For intravenous injection only.
1.5-mL single-use sterile vial.
Discard unused portion.
Close
INGREDIENTS AND APPEARANCE
ALOXI
palonosetron hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-797
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALONOSETRON HYDROCHLORIDE (UNII: 23310D4I19) (PALONOSETRON - UNII:5D06587D6R) PALONOSETRON 0.25 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL (UNII: 3OWL53L36A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-797-01 1 in 1 CARTON
1 5 mL in 1 VIAL; Type 0: Not a Combination Product
Markeing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021372 05/28/2014
ALOXI
palonosetron hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-798
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALONOSETRON HYDROCHLORIDE (UNII: 23310D4I19) (PALONOSETRON - UNII:5D06587D6R) PALONOSETRON 0.075 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL (UNII: 3OWL53L36A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketi |
