Active ingredient
Burosumab
3 finished FDA listings contain Burosumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BUROSUMAB
- Dosage forms
- Injection
- Routes
- Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/ml · 20 mg/ml · 30 mg/ml
- Brand names in FDA listings
- Crysvita
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2043855
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 761068 | KYOWA KIRIN | 2018-04-17 | 3 |
Official labeling on DailyMed
- CRYSVITA (BUROSUMAB) INJECTION [KYOWA KIRIN, INC.] · version 7 · 2026-07-03
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.