NDC Code(s) : 0069-4495-22, 0069-4496-22
Packager : Pfizer Laboratories Div Pfizer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IfosfamideIfosfamide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-4495
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IFOSFAMIDE(UNII: UM20QQM95Y)
(IFOSFAMIDE - UNII:UM20QQM95Y) 		IFOSFAMIDE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
SODIUM PHOSPHATE, DIBASIC ANHYDROUS(UNII: 22ADO53M6F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-4495-2220 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201689 11/27/2012

INGREDIENTS AND APPEARANCE

IfosfamideIfosfamide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-4496
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IFOSFAMIDE(UNII: UM20QQM95Y)
(IFOSFAMIDE - UNII:UM20QQM95Y) 		IFOSFAMIDE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
SODIUM PHOSPHATE, DIBASIC ANHYDROUS(UNII: 22ADO53M6F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-4496-2260 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201689 11/27/2012

PRINCIPAL DISPLAY PANEL

Rx Only

Ifosfamide Injection

1g/20mL (50mg/mL)

20 ml Single Dose Vial

For Intravenous Use

Must be diluted

Isotonic

Sterile

vial-label

Rx Only

Ifosfamide Injection

3g/60mL (50mg/mL)

60 ml Single Dose Vial

For Intravenous Use

Must be diluted

Isotonic

Sterile

vial-label