Label: LYOPHILIZED PEGASPARGASE- pegaspargase injection, powder, lyophilized, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 72694-313-01 - Packager: Servier Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated August 3, 2020
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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 freezeLyophilized Pegaspargase (750 U/mL) Export Only
U/M:Vial
Code:305-21-AR
PC 07795384010495EXP: 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 07795384010495EXP: 07 2025
LOT: 1234F
QTY: 60Case
ALS-305-21-AR-B
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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: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)