Drugplain

Nelarabine 5 mg/mL

Nelarabine · INJECTION, SOLUTION · Sagent Pharmaceuticals

3 Recalls on Record
Plain English

Nelarabine is a injection, solution containing nelarabine at 5 mg/mL, taken intravenous. Manufactured by Sagent Pharmaceuticals.

Key Facts

Brand Name
Nelarabine
Generic Name
Nelarabine
NDC Code (Product)
25021-259
Manufacturer
Sagent Pharmaceuticals
Strength
5 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA212605
Drug Class
Nucleoside Metabolic Inhibitor [EPC]
Marketing Start
08/01/2024

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 contains Nelarabine. It is a injection, solution 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 25021-259, listed by Sagent Pharmaceuticals.