NELARABINE - nelarabine injection 
Zydus Lifesciences Limited

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NELARABINE INJECTION

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1685-1

Nelarabine Injection 250 mg/5 mL (5 mg/mL)

50 mL Single-Dose Vial

For Intravenous Infusion Only

Rx Only

vial label

NDC 70771-1685-1

Nelarabine Injection 250 mg/5 mL (5 mg/mL)

50 mL Single-Dose Vial Carton

For Intravenous Infusion Only

Rx Only

NELARABINE 
nelarabine injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1685
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NELARABINE (UNII: 60158CV180) (NELARABINE - UNII:60158CV180) NELARABINE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1685-11 in 1 CARTON11/17/2021
150 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:70771-1685-86 in 1 CARTON11/17/2021
250 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21503711/17/2021
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650348852ANALYSIS(70771-1685) , MANUFACTURE(70771-1685)

Revised: 11/2022
Document Id: d96809f2-f942-4f6d-92b9-0a23ec84226d
Set id: 877b69a0-0899-455d-926e-f5a7478c31f8
Version: 2
Effective Time: 20221105
 
Zydus Lifesciences Limited