Active ingredient
Rozanolixizumab
4 finished FDA listings contain Rozanolixizumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ROZANOLIXIZUMAB, ROZANOLIXIZUMAB-NOLI
- Dosage forms
- Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 140 mg/ml
- Brand names in FDA listings
- Rystiggo
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2642274
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 761286 | UCB INC | 2023-06-26 | 4 |
Official labeling on DailyMed
- RYSTIGGO (ROZANOLIXIZUMAB) INJECTION, SOLUTION [UCB, INC.] · version 10 · 2026-01-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.