Active ingredient
Nusinersen
3 finished FDA listings contain Nusinersen as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NUSINERSEN
- Dosage forms
- Injection, Solution
- Routes
- Intrathecal
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/ml · 2.4 mg/ml · 5.6 mg/ml
- Brand names in FDA listings
- Spinraza
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1863556
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 |
|---|---|---|---|
| NDA 209531 | BIOGEN | 2016-12-23 | 3 |
Official labeling on DailyMed
- SPINRAZA (NUSINERSEN) INJECTION, SOLUTION [BIOGEN INC.] · version 21 · 2026-04-06
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.