Active ingredient
Nivolumab
4 finished FDA listings contain Nivolumab as their only active ingredient; 3 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- NIVOLUMAB
- Dosage forms
- Injection
- Routes
- Intravenous
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/ml
- Brand names in FDA listings
- Opdivo
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1597876
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 125554 | BRISTOL MYERS SQUIBB | 2014-12-22 | 4 |
Official labeling on DailyMed
- OPDIVO (NIVOLUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] · version 68 · 2026-08-28
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.