NDC Code(s) : 0015-1910-12, 0015-1911-13
Packager : E.R. Squibb & Sons, L.L.C.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IXEMPRAixabepilone KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0015-1910
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0015-1910-121 in 1 PACKAGE, COMBINATION Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022065 10/16/2007
IXEMPRAixabepilone KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0015-1911
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0015-1911-131 in 1 PACKAGE, COMBINATION Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022065 10/16/2007

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Carton Label

Single use vials NDC 70020-1910-1

IXEMPRA ® Kit

(ixabepilone) for injection

15 mg Rx only

For intravenous infusion only

Each carton contains

1 vial IXEMPRA (ixabepilone)
for injection 15 mg

1 vial DILUENT for IXEMPRA 8 mL

Constitution and dilution required
(see insert).

Refrigerate

Distribute by

R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel - Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Carton Label

Single use vials NDC 70020-1911-1

IXEMPRA ® Kit

(ixabepilone) for injection

45 mg Rx only

For intravenous infusion only

Each carton contains

1 vial IXEMPRA (ixabepilone)
for injection 15 mg

1 vial DILUENT for IXEMPRA 23.5 mL

Constitution and dilution required (see insert).

Refrigerate

Distribute by

R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel - Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Vial Label

Single use vial NDC 70020-1910-2

IXEMPRA ®
(ixabepilone) for injection

15 mg Rx only

For intravenous infusion only

Constitution and dilution required
(see insert).

Distributed by R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel - Vial Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Vial Label

Single use vial NDC 70020-1911-2

IXEMPRA ®
(ixabepilone) for injection

45 mg Rx only

For intravenous infusion only

Constitution and dilution required
(see insert).

Distributed by R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel - Vial Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Vial Label

Single use vial NDC 70020-1265-1

DILUENT for
IXEMPRA ®
(ixabepilone) for injection

8 mL Rx only

Not for direct administration

Distributed by R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel - Vial Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Vial Label

Single use vial NDC 70020-1266-2

DILUENT for
IXEMPRA ®
(ixabepilone) for injection

23.5 mL Rx only

Not for direct administration

Distributed by R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel - Vial Label