Active ingredient
Lecanemab
4 finished FDA listings contain Lecanemab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LECANEMAB, LECANEMAB-IRMB
- Dosage forms
- Injection, Solution
- Routes
- Intravenous, Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 100 mg/ml · 200 mg/ml
- Brand names in FDA listings
- Lecanemab Autoinjector, Leqembi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2626143
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 761269 | EISAI INC | 2023-01-06 | 2 |
| BLA 761375 | EISAI INC | 2025-08-29 | 2 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.