Drugplain

Nelarabine 5 mg/mL

Nelarabine · INJECTION · XGen Pharmaceuticals DJB, Inc.

3 Recalls on Record
Plain English

Nelarabine is a injection containing nelarabine at 5 mg/mL, taken intravenous. Manufactured by XGen Pharmaceuticals DJB, Inc..

Key Facts

Brand Name
Nelarabine
Generic Name
Nelarabine
NDC Code (Product)
39822-0650
Manufacturer
XGen Pharmaceuticals DJB, Inc.
Strength
5 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA216510
Drug Class
Nucleoside Metabolic Inhibitor [EPC]
Marketing Start
02/17/2025

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 contains Nelarabine. It is a injection taken intravenous. Consult your doctor for specific uses.

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 39822-0650, listed by XGen Pharmaceuticals DJB, Inc..

Product NDC

39822-0650

Package NDC

39822-0650-1

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

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