Spinraza
- Product NDC
- 64406-036
- 11-digit product format
- 644060036
- Labeler code
- 64406
- Product ID
- 64406-036_cb572584-c0fd-42aa-b6d1-6dd8260028b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nusinersen
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Labeler
- Biogen Inc.
- Application
- NDA209531
- Marketing category
- NDA
- Marketing start
- 2026-03-27
- Substance
- NUSINERSEN
- Active strength
- 5.6 mg/mL
- Pharmacologic classes
- Antisense Oligonucleotide [EPC], Increased Protein Synthesis [PE], Oligonucleotides, Antisense [CS], Survival Motor Neuron-2-directed RNA Interaction [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 5Z9SP3X666 | NUSINERSEN | 1258984-36-9 | NUSINERSEN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 64406-036-01 | 64406003601 | 1 VIAL, SINGLE-USE in 1 BOX (64406-036-01) / 5 mL in 1 VIAL, SINGLE-USE | 2026-03-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Spinraza | Biogen Inc. | 2026-03-31 | HUMAN PRESCRIPTION DRUG LABEL | 21 |