Active ingredient
Tocilizumab
22 finished FDA listings contain Tocilizumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TOCILIZUMAB
- Dosage forms
- Injection, Injection, Solution, Injection, Solution, Concentrate
- Routes
- Intravenous, Subcutaneous
- Manufacturers / labelers
- 5
- Strengths listed
- 162 mg/.9ml · 20 mg/ml · 200 mg/10ml · 400 mg/20ml · 80 mg/4ml
- Brand names in FDA listings
- Actemra, Actemra Actpen, Avtozma, Tofidence, Tyenne
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 612865
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 125276 | GENENTECH | 2010-01-08 | 3 |
| BLA 125472 | GENENTECH | 2013-10-21 | 2 |
| BLA 761354 | BIOGEN MA | 2023-09-29 | 6 |
| BLA 761275 | FRESENIUS KABI USA | 2024-03-05 | 5 |
| BLA 761420 | CELLTRION INC | 2025-01-24 | 3 |
| BLA 761449 | FRESENIUS KABI USA | 2025-03-14 | 2 |
| BLA 761498 | CELLTRION INC | 2026-01-21 | 1 |
Official labeling on DailyMed
- TYENNE (TOCILIZUMAB-AAZG) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 6 · 2026-08-31
- TYENNE (TOCILIZUMAB-AAZG) INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] · version 3 · 2026-08-17
- TYENNE (TOCILIZUMAB-AAZG) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 3 · 2026-08-04
- AVTOZMA (TOCILIZUMAB) INJECTION, SOLUTION [CELLTRION USA, INC.] · version 7 · 2026-07-29
- TOFIDENCE (TOCILIZUMAB) INJECTION [ORGANON LLC] · version 5 · 2026-06-05
- TOFIDENCE (TOCILIZUMAB) INJECTION [BIOGEN MA INC] · version 10 · 2026-01-14
- ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION ACTEMRA ACTPEN (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] · version 53 · 2025-12-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.