Drugplain

Oxaliplatin 5 mg/mL

Oxaliplatin · INJECTION, SOLUTION, CONCENTRATE · Fresenius Kabi USA, LLC

4 Recalls on RecordCurrently in Shortage
Plain English

Oxaliplatin is a platinum-based chemotherapy medication given by injection into a vein to treat colorectal cancer and certain other cancers, often used as part of combination chemotherapy regimens. It works by damaging cancer cell DNA to slow or stop tumor growth.

Key Facts

Brand Name
Oxaliplatin
Generic Name
Oxaliplatin
NDC Code (Product)
63323-750
Manufacturer
Fresenius Kabi USA, LLC
Strength
5 mg/mL
Dosage Form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Marketing Status
Application #
ANDA078811
Drug Class
Platinum-based Drug [EPC]
Marketing Start
06/11/2010

Recall History

4 Recalls on Record
Class II08/29/2019

Johnson Matthey Inc.

cGMP Deviations: Potential glass contamination

TerminatedVoluntary: Firm initiated
Class II02/06/2012

sanofi-aventis US, Inc.

CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class II02/06/2012

sanofi-aventis US, Inc.

CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class II06/12/2019

Infusion Options, Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea6,740 reports
nausea5,282 reports
off label use4,512 reports
vomiting4,301 reports
disease progression4,233 reports
neuropathy peripheral4,158 reports
neutropenia4,129 reports
thrombocytopenia3,458 reports
dyspnoea2,998 reports
pyrexia2,818 reports

Frequently Asked Questions

What is Oxaliplatin used for?

Oxaliplatin is a platinum-based chemotherapy medication given by injection into a vein to treat colorectal cancer and certain other cancers, often used as part of combination chemotherapy regimens. It works by damaging cancer cell DNA to slow or stop tumor growth.

Is Oxaliplatin a controlled substance?

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

What is the generic name for Oxaliplatin?

The generic name for Oxaliplatin is Oxaliplatin. There are 1 other brand versions of Oxaliplatin.

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

The NDC (National Drug Code) for Oxaliplatin 5 mg/mL is 63323-750, listed by Fresenius Kabi USA, LLC.