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 Servier Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - Shipping Label

Manufactured By:
Exelead, Inc.
Indianapolis, IN 46268, USA
Distributed By:
Les Laboratoires Servier
92284 Suresnes, France
Store Between 2°C and 8°C (36°F to 46°F)
Do not freeze

Lyophilized Pegaspargase (750 U/mL) Export Only
U/M:Vial
Code:305-21-AR
PC 07795384010495

EXP: 07 2025

LOT: 1234F

Pallet

PLS-305-21-AR-B

Manufactured By: Exelead, Inc.
Indianapolis, IN 46268, USA
Distributed By: Les Laboratoires Servier
92284 Suresnes, France
Store Between 2°C and 8°C (36°F to 46°F)
Do not freeze
Lyophilized Pegaspargase (750 U/mL) Export Only
U/M:Vial
Code:305-21-AR
PC 07795384010495

EXP: 07 2025
LOT: 1234F
QTY: 60

Case

ALS-305-21-AR-B

INGREDIENTS AND APPEARANCE

LYOPHILIZED PEGASPARGASE 
pegaspargase injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72694-313
Route of Administration	INTRAVENOUS

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCROSE (UNII: C151H8M554)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72694-313-01	1 in 1 CARTON	08/03/2020
1		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		08/03/2020

Labeler - Servier Pharmaceuticals (116608503)