Nelarabine Injection

SPL v2

SPL

SPL Set ID 877b69a0-0899-455d-926e-f5a7478c31f8

Route

INTRAVENOUS

Published

Effective Date 2022-11-05

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Nelarabine (5 mg)

Inactive Ingredients

Hydrochloric Acid Sodium Chloride Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2021-11-17

Description

Medication Information

Description

Section 42229-5

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

Structured Label Content

Section 42229-5 (42229-5)

Package Label.principal Display Panel (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

Advanced Ingredient Data

[{"name": "NELARABINE", "unii": "60158CV180", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"42229-5": ".", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:37:28.967629 · Updated: 2026-03-14T21:50:25.596456