Active ingredient
Guselkumab
3 finished FDA listings contain Guselkumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GUSELKUMAB
- Dosage forms
- Injection
- Routes
- Intravenous, Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 100 mg/ml · 200 mg/20ml · 200 mg/2ml
- Brand names in FDA listings
- Tremfya
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1928588
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 761061 | JANSSEN BIOTECH | 2017-07-13 | 3 |
Official labeling on DailyMed
- TREMFYA (GUSELKUMAB) INJECTION TREMFYA (GUSELKUMAB) INJECTION [JANSSEN BIOTECH, INC.] · version 29 · 2026-06-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.