Nelarabine by Zydus Lifesciences Limited NELARABINE injection

Nelarabine by

Drug Labeling and Warnings

Nelarabine by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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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

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

INGREDIENTS AND APPEARANCE

NELARABINE 
nelarabine injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1685
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NELARABINE (UNII: 60158CV180) (NELARABINE - UNII:60158CV180)	NELARABINE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1685-1	1 in 1 CARTON	11/17/2021
1		50 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC: 70771-1685-8	6 in 1 CARTON	11/17/2021
2		50 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215037	11/17/2021

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		650348852	ANALYSIS(70771-1685) , MANUFACTURE(70771-1685)