Active ingredient
Dupilumab
4 finished FDA listings contain Dupilumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DUPILUMAB
- Dosage forms
- Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 200 mg/1.14ml · 300 mg/2ml
- Brand names in FDA listings
- Dupixent
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1876376
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 761055 | REGENERON PHARMACEUTICALS | 2017-03-28 | 4 |
Official labeling on DailyMed
- DUPIXENT (DUPILUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] · version 60 · 2026-08-07
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.