Drugplain

Nelarabine 5 mg/mL

Nelarabine · INJECTION · Gland Pharma Limited

3 Recalls on Record
Plain English

Nelarabine is a nucleoside metabolic inhibitor given by intravenous injection that is used to treat certain types of leukemia and lymphoma, particularly in patients who have not responded to other treatments. It works by interfering with cancer cell growth and division.

Key Facts

Brand Name
Nelarabine
Generic Name
Nelarabine
NDC Code (Product)
68083-233
Manufacturer
Gland Pharma Limited
Strength
5 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA212605
Drug Class
Nucleoside Metabolic Inhibitor [EPC]
Marketing Start
01/03/2024

Recall History

3 Recalls on Record
Class II02/13/2025

Zydus Pharmaceuticals (USA) Inc

Failed Impurities/Degradation Specifications

OngoingVoluntary: Firm initiated
Class II10/08/2012

GlaxoSmithKline, LLC.

Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.

TerminatedVoluntary: Firm initiated
Class II02/13/2025

Zydus Pharmaceuticals (USA) Inc

Failed Impurities/Degradation Specifications

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is Nelarabine used for?

Nelarabine is a nucleoside metabolic inhibitor given by intravenous injection that is used to treat certain types of leukemia and lymphoma, particularly in patients who have not responded to other treatments. It works by interfering with cancer cell growth and division.

Is Nelarabine a controlled substance?

Nelarabine is not classified as a controlled substance by the DEA.

What is the generic name for Nelarabine?

The generic name for Nelarabine is Nelarabine. There are 5 other brand versions of Nelarabine.

What is the NDC code for Nelarabine 5 mg/mL?

The NDC (National Drug Code) for Nelarabine 5 mg/mL is 68083-233, listed by Gland Pharma Limited.

Product NDC

68083-233

Package NDC

68083-233-06

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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