Active ingredient
Rituximab
8 finished FDA listings contain Rituximab as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- RITUXIMAB, RITUXIMAB-PVVR
- Dosage forms
- Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 4
- Strengths listed
- 10 mg/ml · 100 mg/10ml · 500 mg/50ml
- Brand names in FDA listings
- Riabni, Rituxan, Ruxience, Truxima
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 121191
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 103705 | GENENTECH | 1997-11-26 | 2 |
| BLA 761088 | CELLTRION INC | 2018-11-28 | 2 |
| BLA 761103 | PFIZER INC | 2019-07-23 | 2 |
| BLA 761140 | AMGEN INC | 2020-12-17 | 2 |
Official labeling on DailyMed
- RUXIENCE (RITUXIMAB-PVVR) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] · version 12 · 2026-08-28
- RIABNI (RITUXIMAB-ARRX) INJECTION, SOLUTION [AMGEN, INC] · version 12 · 2026-07-29
- TRUXIMA (RITUXIMAB-ABBS) INJECTION, SOLUTION [CEPHALON, INC.] · version 16 · 2026-07-17
- RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.] · version 36 · 2025-01-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.