Active ingredient
Emicizumab
6 finished FDA listings contain Emicizumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- EMICIZUMAB, EMICIZUMAB-KXWH
- Dosage forms
- Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 105 mg/.7ml · 12 mg/.4ml · 150 mg/ml · 30 mg/ml · 300 mg/2ml · 60 mg/.4ml
- Brand names in FDA listings
- Hemlibra
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1989794
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 761083 | GENENTECH INC | 2017-11-16 | 6 |
Official labeling on DailyMed
- HEMLIBRA (EMICIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] · version 17 · 2025-07-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.