![LYOPHILIZED PEGASPARGASE (PEGASPARGASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXALTA US INC.]](https://medic.hrt.org//dailymed/images/2b1212ae-3f17-4e7f-811b-c03c391f5dc3/pegaspargase-01.jpg)
| NDC | 0944-3922-01, 0944-3922-02 |
| Set ID | 2b1212ae-3f17-4e7f-811b-c03c391f5dc3 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Baxalta US Inc. |
| Generic Name | |
| Product Class | Asparagine-specific Enzyme |
| Product Number | |
| Application Number |
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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, USA999
- Per ISS-_______, under CSWO # __________ added new
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INGREDIENTS AND APPEARANCE
LYOPHILIZED PEGASPARGASE
pegaspargase injection, powder, lyophilized, for solutionProduct 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 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 Labeler - Baxalta US Inc. (079887619) Establishment Name Address ID/FEI Business Operations Exelead, Inc 961822389 MANUFACTURE(0944-3922) , PACK(0944-3922) , LABEL(0944-3922)