OPDIVO 10 mg/mL
nivolumab · INJECTION · E.R. Squibb & Sons, L.L.C.
2 Recalls on Record
Plain English
OPDIVO is a injection containing nivolumab at 10 mg/mL, taken intravenous. Manufactured by E.R. Squibb & Sons, L.L.C..
Key Facts
- Brand Name
- OPDIVO
- Generic Name
- nivolumab
- NDC Code (Product)
0003-3734- Manufacturer
- E.R. Squibb & Sons, L.L.C.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125554
- Drug Class
- Programmed Death Receptor-1 Blocking Antibody [EPC]
- Marketing Start
- 12/08/2017
Recall History
2 Recalls on Record
Class II06/12/2019
Infusion Options, Inc.
Lack of Assurance of Sterility
TerminatedVoluntary: Firm initiated
Class II04/03/2018
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
TerminatedVoluntary: Firm initiated
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
death11,724 reports
malignant neoplasm progression9,729 reports
off label use6,139 reports
diarrhoea5,154 reports
fatigue4,112 reports
pyrexia3,660 reports
intentional product use issue3,331 reports
nausea3,132 reports
rash3,035 reports
decreased appetite2,866 reports
Frequently Asked Questions
What is OPDIVO used for?
OPDIVO contains nivolumab. It is a injection taken intravenous. Consult your doctor for specific uses.
Is OPDIVO a controlled substance?
OPDIVO is not classified as a controlled substance by the DEA.
What is the generic name for OPDIVO?
The generic name for OPDIVO is nivolumab. There are 3 other brand versions of nivolumab.
What is the NDC code for OPDIVO 10 mg/mL?
The NDC (National Drug Code) for OPDIVO 10 mg/mL is 0003-3734, listed by E.R. Squibb & Sons, L.L.C..