Active ingredient
Evolocumab
5 finished FDA listings contain Evolocumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- EVOLOCUMAB
- Dosage forms
- Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 140 mg/ml
- Brand names in FDA listings
- Repatha
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1665684
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 125522 | AMGEN INC | 2015-08-27 | 5 |
Official labeling on DailyMed
- REPATHA (EVOLOCUMAB) INJECTION, SOLUTION REPATHA (EVOLOCUMAB) KIT [AMGEN USA INC.] · version 32 · 2026-08-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.