NDC Code(s) : 47335-581-40, 47335-581-42
Packager : Sun Pharma Global FZE

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

amifostine amifostine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-581
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIFOSTINE(UNII: M487QF2F4V)
(AMIFOSTINE ANHYDROUS - UNII:ILA426L95O) 		AMIFOSTINE ANHYDROUS50 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-581-401 in 1 CARTON
110 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
2NDC:47335-581-423 in 1 CARTON
210 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077126 03/14/2008

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - vial label

NDC 47335-581-40
Amifostine for Injection USP
500 mg/vial
Sterile
Single use vial
For Intravenous Use
Rx only
amifostine-label

PRINCIPAL DISPLAY PANEL - showbox for 1 vial
NDC 47335-581-40
Amifostine for Injection USP
500 mg/vial
Sterile
Single use vials
For Intravenous Use
1 Vial
Rx only
SUN PHARMA


amifostine-label

PRINCIPAL DISPLAY PANEL - showbox for 3 vials


NDC 47335-581-42
Amifostine for Injection USP
500 mg/vial
Sterile
Single use vials
For Intravenous Use
3 Vials
Rx only
SUN PHARMA
amifostine-label