Active ingredient
Alirocumab
4 finished FDA listings contain Alirocumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ALIROCUMAB
- Dosage forms
- Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 2
- Strengths listed
- 150 mg/ml · 75 mg/ml
- Brand names in FDA listings
- Praluent
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1659152
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 125559 | REGENERON PHARMACEUTICALS | 2015-07-24 | 4 |
Official labeling on DailyMed
- PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] · version 35 · 2026-07-24
- PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.] · version 10 · 2026-07-24
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.