NDC Code(s) : 10019-955-50, 10019-955-01, 10019-956-16, 10019-956-01, 10019-957-11, 10019-957-01
Packager : Baxter Healthcare Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cyclophosphamidecyclophosphamide INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10019-955
Route of Administration INTRAVENOUS, ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOPHOSPHAMIDE(UNII: 8N3DW7272P)
(CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M) 		CYCLOPHOSPHAMIDE ANHYDROUS500 mg in 25 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10019-955-011 in 1 CARTON 21/05/2008
1NDC:10019-955-5025 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040745 05/21/2008
Cyclophosphamidecyclophosphamide INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10019-956
Route of Administration INTRAVENOUS, ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOPHOSPHAMIDE(UNII: 8N3DW7272P)
(CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M) 		CYCLOPHOSPHAMIDE ANHYDROUS1 g in 50 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10019-956-011 in 1 CARTON 21/05/2008
1NDC:10019-956-1650 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040745 05/21/2008
Cyclophosphamidecyclophosphamide INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10019-957
Route of Administration INTRAVENOUS, ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOPHOSPHAMIDE(UNII: 8N3DW7272P)
(CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M) 		CYCLOPHOSPHAMIDE ANHYDROUS2 g in 100 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10019-957-011 in 1 CARTON 21/05/2008
1NDC:10019-957-11100 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040745 05/21/2008

LABELER - Baxter Healthcare Corporation(005083209)

REGISTRANT - Baxter Healthcare Corporation(005083209)

Establishment
Name Address ID/FEI Business Operations
Baxter Oncology GmbH 344276063 ANALYSIS(10019-955, 10019-956, 10019-957), LABEL(10019-955, 10019-956, 10019-957), MANUFACTURE(10019-955, 10019-956, 10019-957), PACK(10019-955, 10019-956, 10019-957), STERILIZE(10019-955, 10019-956, 10019-957), API MANUFACTURE(10019-955, 10019-956, 10019-957)

PRINCIPAL DISPLAY PANEL

Cyclophosphamide Baxter Representative Container LBL 10019-955-50_HA6501628Container Label

LOT/EXP:

NDC 10019-955-50

Cyclophosphamide
for Injection, USP

500 mg/vial CYTOTOXIC AGENT

FOR SINGLE DOSE USE
STERILE, NON-PYROGENIC
FOR PARENTERAL USE

Rx only

Baxter Logo
Manufactured by Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany
460-629-01

Each vial contains 500 mg cyclophosphamide.

For IV Infusion Use: Add 25 mL Sterile
Water for Injection, USP, and shake
vigorously to dissolve the drug.

For Direct Injection Use: Add 25 mL
0.9% Sodium Chloride Injection, USP,
and shake vigorously to dissolve
the drug.

See insert for indications and dosage
schedule. Store vial at or below 25˚C
(77˚F) [see USP Controlled Room
Temperature].

Bar Code
(01)00310019955506

USA HA-65-01-628 C 273

Bar Code

Cyclophosphamide Baxter Representative Container LBL 10019-955-50_HA6501628Cyclophosphamide Baxter Representative Container LBL 10019-955-50_HA6501628Carton Label

NDC 10019-955-01

Cyclophosphamide
for Injection, USP

500 mg/vial
Rx only

MUST BE DILUTED
FOR IV INFUSION
OR DIRECT INJECTION USE

1 Single Dose Vial

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany

Cyclophosphamide
for Injection, USP

500 mg/vial

Bar Code

HA-80-02-313
USA

Each vial contains 500 mg cyclophosphamide.

For IV Infusion Use: Add 25 mL Sterile Water
for Injection, USP, and shake vigorously to
dissolve the drug.

For Direct Injection Use: Add 25 mL 0.9%
Sodium Chloride Injection, USP, and shake
vigorously to dissolve the drug.

Store vial at or below 25°C (77°F)
[see USP Controlled Room Temperature].

DOSAGE: See accompanying literature for
directions for use. Should not be prescribed
without thorough knowledge of dose,
indications and toxicity as contained in
accompanying literature.

CYTOTOXIC AGENT

FOR SINGLE DOSE USE
STERILE, NON-PYROGENIC
FOR PARENTERAL USE

460-630-01

C
628

NDC 10019-955-01

Cyclophosphamide
for Injection, USP

500 mg/vial
Rx only

MUST BE DILUTED
FOR IV INFUSION
OR DIRECT INJECTION USE

1 Single Dose Vial

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany

LOT /EXP:

2638B5071

Barcode

FOLDING BOX
CAN BE RECYCLED Symbol

NDC 10019-955-01

Cyclophosphamide
for Injection, USP

500 mg/vial
Rx only

MUST BE DILUTED
FOR IV INFUSION
OR DIRECT INJECTION USE

1 Single Dose Vial

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany

Cyclophosphamide Baxter Representative Container LBL 10019-955-50_HA6501628Container Label

LOT/EXP:

NDC 10019-956-16

Cyclophosphamide
for Injection, USP

1 gram/vial CYTOTOXIC AGENT

FOR SINGLE DOSE USE
STERILE, NON-PYROGENIC
FOR PARENTERAL USE

Rx only

Baxter Logo
Manufactured by Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany
460-631-01

Each vial contains 1 g cyclophosphamide.

For IV Infusion Use: Add 50 mL Sterile
Water for Injection, USP, and shake
vigorously to dissolve the drug.

For Direct Injection Use: Add 50 mL
0.9% Sodium Chloride Injection,
USP, and shake vigorously to dissolve
the drug.

See insert for indications and dosage
schedule. Store vial at or below 25˚C
(77˚F) [see USP Controlled Room
Temperature].

Bar Code
(01)00310019956169

USA HA-65-01-629
C 270

Bar Code

Cyclophosphamide Baxter Representative Container LBL 10019-955-50_HA6501628Cyclophosphamide Baxter Representative Container LBL 10019-955-50_HA6501628Carton Label

NDC 10019-956-01

Cyclophosphamide
for Injection, USP

1 gram/vial
Rx only

MUST BE DILUTED
FOR IV INFUSION
OR DIRECT INJECTION USE

1 Single Dose Vial

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany

Cyclophosphamide
for Injection, USP

1 gram/vial

HA-80-02-314
USA

Each vial contains 1 g cyclophosphamide.

For IV Infusion Use: Add 50 mL Sterile Water
for Injection, USP, and shake vigorously to
dissolve the drug.

For Direct Injection Use: Add 50 mL 0.9%
Sodium Chloride Injection, USP, and shake
vigorously to dissolve the drug.

Store vial at or below 25°C 77°F)
[see USP Controlled Room Temperature].

DOSAGE: See accompanying literature for
directions for use. Should not be prescribed
without thorough knowledge of dose,
indications and toxicity as contained in
accompanying literature.

CYTOTOXIC AGENT

FOR SINGLE DOSE USE
STERILE, NON-PYROGENIC
FOR PARENTERAL USE

460-632-01

C
626

NDC 10019-956-01

Cyclophosphamide
for Injection, USP

1 gram/vial Rx only

MUST BE DILUTED
FOR IV INFUSIONOR
DIRECT INJECTION USE

1 Single Dose Vial

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany

LOT /EXP:

2638B5072

Barcode

FOLDING BOX
CAN BE RECYCLED Symbol

NDC 10019-956-01

Cyclophosphamide
for Injection, USP

1 gram/vial
Rx only

MUST BE DILUTED
FOR IV INFUSIONOR
DIRECT INJECTION USE

1 Single Dose Vial

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany

Cyclophosphamide Baxter Representative Container LBL 10019-955-50_HA6501628Container Label

LOT/EXP:

NDC 10019-957-11

Cyclophosphamide
for Injection, USP

2 gram/vial CYTOTOXIC AGENT

FOR SINGLE DOSE USE
STERILE, NON-PYROGENIC
FOR PARENTERAL USE

Rx only

Baxter Logo
Manufactured by Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany
460-633-01

Each vial contains 2 g cyclophosphamide.

For IV Infusion Use: Add 100 mL
Sterile Water for Injection, USP, and
shake vigorously to dissolve the drug.

For Direct Injection Use: Add 100 mL
0.9% Sodium Chloride Injection, USP,
and shake vigorously to dissolve
the drug.

See insert for indications and dosage
schedule. Store vial at or below 25˚C
(77˚F) [see USP Controlled Room
Temperature].

Barcode

(01)00310019957111

USA HA-65-01-630
C271

Cyclophosphamide Baxter Representative Container LBL 10019-955-50_HA6501628Cyclophosphamide Baxter Representative Container LBL 10019-955-50_HA6501628Carton Label

NDC 10019-957-01

Cyclophosphamide
for Injection, USP

2 gram/vial
Rx only

MUST BE DILUTED
FOR IV INFUSION
OR DIRECT INJECTION USE

1 Single Dose Vial

BaxterLogo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany

Cyclophosphamide
for Injection, USP

2 gram/vial

Bar Code

HA-80-02-315
USA

Each vial contains 2 g cyclophosphamide.

For IV Infusion Use: Add 100 mL Sterile
Water for Injection, USP, and shake vigorously to
dissolve the drug.

For Direct Injection Use: Add 100 mL
0.9% Sodium Chloride Injection, USP, and
shake vigorously to dissolve the drug.

Store vial at or below 25°C 77°F)
[see USP Controlled Room Temperature].

DOSAGE: See accompanying literature
for directions for use. Should not be prescribed
without thorough knowledge of dose,
indications and toxicity as contained in
accompanying literature.

CYTOTOXIC AGENT

FOR SINGLE DOSE USE
STERILE, NON-PYROGENIC
FOR PARENTERAL USE

460-634-01

C
627

NDC 10019-957-01

Cyclophosphamide
for Injection, USP

2 gram/vial
Rx only

MUST BE DILUTED
FOR IV INFUSIONOR
DIRECT INJECTION USE

1 Single Dose Vial

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany

LOT /EXP:

2638B5073

Bar Code

NDC 10019-957-01

Cyclophosphamide
for Injection, USP

2 gram/vial
Rx only

MUST BE DILUTED
FOR IV INFUSIONOR
DIRECT INJECTION USE

1 Single Dose Vial

Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany

FOLDING BOX
CAN BE RECYCLED Symbol