Nelarabine Injection
FDA Label NDC 70771-1685

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Nelarabine (NDC 70771-1685). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

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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 (3fdea8e8 07e5 41bc 964d 34b7a82e24f1 01)

Vial Label (3fdea8e8 07e5 41bc 964d 34b7a82e24f1 01)

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

1's Carton (3fdea8e8 07e5 41bc 964d 34b7a82e24f1 02)

1's Carton (3fdea8e8 07e5 41bc 964d 34b7a82e24f1 02)

NDC 70771-1685-8

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

6 x 50 mL Single-Dose Vial

For Intravenous Infusion Only

Rx Only

6's Carton (3fdea8e8 07e5 41bc 964d 34b7a82e24f1 03)

6's Carton (3fdea8e8 07e5 41bc 964d 34b7a82e24f1 03)

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