LYOPHILIZED PEGASPARGASE- pegaspargase injection, powder, lyophilized, for solution

Lyophilized Pegaspargase by

Drug Labeling and Warnings

Lyophilized Pegaspargase by is a Prescription medication manufactured, distributed, or labeled by Baxalta US Inc., Exelead, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - Shipping Label

Master Label

Description:

SHIPPER LABEL Lyophilized Pegaspargase for ____________

Item Code:

SL30521XXX 1

User Group:

Materials Management

New [ X ] Revised [ ]

Reason for Master Label:

• Per ISS-_______, under CSWO # __________ added new
  shipper label info for Lyophilized Pegaspargase _____________
  to the Weber label database table.
• Label master template will pull product specific information
  from access database securely from the Weber workstation.

Weber Archive Name:

Shipper Label.___

Created by/Date:

Approved by/Date:

1 Shipper Labels are site-created components revised by alpha sequence on the label and Master Label document. In
SAP the templates are listed by base item code only.

LYOPHILIZED PEGASPARGASE

Code: 305-21-

Exp. Date: F251-0019-01

Lot #: XXXXX

U/M: Vial

Qty: 60

SL30521

Exelead, Inc.
Indianapolis, IN 46268, USA

999

INGREDIENTS AND APPEARANCE

LYOPHILIZED PEGASPARGASE 
pegaspargase injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0944-3922
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PEGASPARGASE (UNII: 7D96IR0PPM) (PEGASPARGASE - UNII:7D96IR0PPM)	PEGASPARGASE	750 U  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0944-3922-02	60 in 1 CARTON	02/07/2018	05/16/2020
1	NDC: 0944-3922-01	5 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
EXPORT ONLY		02/07/2018	05/16/2020

Labeler - Baxalta US Inc. (079887619)

Establishment
Name	Address	ID/FEI	Business Operations
Exelead, Inc		961822389	MANUFACTURE(0944-3922) , PACK(0944-3922) , LABEL(0944-3922)