IFEX (Page 6 of 6)

PACKAGE LABEL — PRINCIPLE DISPLAY PANEL

IFEX Container Label
(click image for full-size original)

Container Label

NDC 0338-3991-01

IFEX
IFOSFAMIDE FOR INJECTION, USP

1 g/vial

Rx only

SINGLE-DOSE VIAL

This vial contains 1g ifosfamide.
Add 20 mL Sterile Water for
Injection, USP, or Sterile
Bacteriostatic Water for Injection,
USP, (benzyl alcohol or parabens
preserved), shaking to dissolve,
for a reconstituted concentration
of 50 mg per mL.

Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F)
Protect from temperatures
above 30° C (86° F).

FOR IV USE
READ ACCOMPANYING
PACKAGE INSERT for detailed
indications, dosage, and
precautions.

Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

USA HA-65-01-561

C130

Bar Code
N(01)1 03 0338 3991 01 7

Lot:/Exp.:

JMXXXMMJJJJ

IFEX Carton Label 1 of 2
(click image for full-size original)

IFEX Carton Label 2 of 2
(click image for full-size original)

Carton Label

1 vial

NDC 0338-3991-01

IFEX
(ifosfamide for injection, USP)

Single-Dose Vial
FOR IV USE

Rx only

1 g

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

See bottom panel for lot
number and expiration date.

Bar Code
N3 0338399101 0

This vial contains 1 g ifosfamide. Add
20 mL Sterile Water for Injection, USP,
or Sterile Bacteriostatic Water for
Injection, USP, (benzyl alcohol or
parabens preserved), shaking to
dissolve, for a reconstituted
concentration of 50 mg per mL.

READ ACCOMPANYING PACKAGE
INSERT for detailed indications,
dosage, and precautions.

Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F). Protect from
temperatures above 30° C (86° F).

Constituted solutions should be
refrigerated and used within 24 hours.

Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USAMade in Germany

Ifosfamide container label
(click image for full-size original)

Container Label

NDC 0338-3993-01

IFEX
IFOSFAMIDE FOR INJECTION, USP

3 g/vial

Rx only

SINGLE-DOSE VIAL

This vial contains 3g ifosfamide.
Add 60 mL Sterile Water for
Injection, USP, or Sterile
Bacteriostatic Water for Injection,
USP, (benzyl alcohol or parabens
preserved), shaking to dissolve,
for a reconstituted concentration
of 50 mg per mL.

Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F)
Protect from temperatures
above 30° C (86° F).

FOR IV USE
READ ACCOMPANYING
PACKAGE INSERT for detailed
indications, dosage, and
precautions.

Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

USA HA-65-01-564
C 132

Bar CodeN(01)1 03 0338 3993 01 1

Lot:/Exp.:

JMXXX

MM.JJJJ

Ifex Representative Carton Label 0338-3993-01 1 of 2
(click image for full-size original)
Ifex Representative Carton Label 0338-3993-01 2 of 2
(click image for full-size original)

Carton Label

1 vial

NDC 0338-3993-01

IFEX
(ifosfamide for injection, USP)

Single-Dose Vial
FOR IV USE

Rx only

3 g /vial

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

HA-80-02-154
USA

See bottom panel for lot
number and expiration date.

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

C
837

(01) 0030338993014
(21) XXXXXXXXXXXX
(17) JJMMTT
(10)JMXXXA

1 vial NDC 0338-3993-01

IFEX
(Ifosfamide for injection, USP)

Single Dose Vial
Rx only
FOR IV USE

3 g /vial

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Lot/Exp.:

JMXXXA
MMJJJJ

2617B5079

Barcode

FOLDING BOX
CAN BE RECYCLED symbol

This vial contains 3 g ifosfamide.
Add 60 mL Sterile Water for
Injection, USP, or Sterile
Bacteriostatic Water for Injection,
USP, (benzyl alcohol or parabens
preserved), shaking to dissolve,
for a reconstituted concentration
of 50 mg per mL.

READ ACCOMPANYING PACKAGE
INSERT for detailed indications,
dosage, and precautions.

Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F). Protect from
temperatures above 30° C (86° F).

Constituted solutions should be
refrigerated and used within 24 hours.

Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USAMade in Germany

IFEX ifosfamide injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-3991
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IFOSFAMIDE (IFOSFAMIDE) IFOSFAMIDE 1 g in 20 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-3991-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0338-3991-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019763 12/30/1988
IFEX ifosfamide injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-3993
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IFOSFAMIDE (IFOSFAMIDE) IFOSFAMIDE 3 g in 60 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-3993-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 60 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0338-3993-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019763 12/30/1988
Labeler — Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Oncology GmbH 344276063 ANALYSIS (0338-3991), ANALYSIS (0338-3993), MANUFACTURE (0338-3991), MANUFACTURE (0338-3993), LABEL (0338-3991), LABEL (0338-3993), PACK (0338-3991), PACK (0338-3993), STERILIZE (0338-3991), STERILIZE (0338-3993)

Revised: 07/2018 Baxter Healthcare Corporation

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