NDC Code(s) : 62856-350-08, 62856-350-58
Packager : Eisai, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LUSEDRA fospropofol disodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-350
Route of Administration INTRAVENOUS DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSPROPOFOL DISODIUM(UNII: 30868AY0IF)
(FOSPROPOFOL - UNII:LZ257RZP7K) 		FOSPROPOFOL DISODIUM35 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MONOTHIOGLYCEROL(UNII: AAO1P0WSXJ)
TROMETHAMINE(UNII: 023C2WHX2V)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-350-088 in 1 TRAY
130 mL in 1 VIAL
2NDC:62856-350-588 in 1 TRAY
230 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022244 12/12/2008

PRINCIPAL DISPLAY PANEL

NDC # 62856-350-08

LUSEDRA™
(fospropofol disodium)
Injection C-IV

1050 mg/30 mL
(35 mg/mL)

For Intravenous Use Only
Single-use vial. Discard unused portion.

RX ONLY

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