Spinraza
- Product NDC
- 64406-037
- 11-digit product format
- 644060037
- Labeler code
- 64406
- Product ID
- 64406-037_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
- 10 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Spinraza
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NUSINERSEN | 10 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 5Z9SP3X666 |
| Rxcui | 1863560, 1863565, 2739995, 2739998, 2740001, 2740004 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64406-037-01 | Spinraza | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 5 | 21 | |
| 64406-037-01 | Spinraza | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64406-037-01 | ML - Milliliter | 64406-037 | 248689db-1ff6-475c-828e-fa584545a61d | 1 | 2026-04-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1863560 | nusinersen 12 MG in 5 ML Injection | PSN | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2740001 | nusinersen 28 MG in 5 ML Injection | PSN | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2739995 | nusinersen 50 MG in 5 ML Injection | PSN | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 1863565 | Spinraza 12 MG in 5 ML Injection | PSN | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2740004 | SPINRAZA 28 MG in 5 ML Injection | PSN | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2739998 | SPINRAZA 50 MG in 5 ML Injection | PSN | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2739998 | 5 ML nusinersen 10 MG/ML Injection [Spinraza] | SBD | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 1863565 | 5 ML nusinersen 2.4 MG/ML Injection [Spinraza] | SBD | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2740004 | 5 ML nusinersen 5.6 MG/ML Injection [Spinraza] | SBD | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2739995 | 5 ML nusinersen 10 MG/ML Injection | SCD | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 1863560 | 5 ML nusinersen 2.4 MG/ML Injection | SCD | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2740001 | 5 ML nusinersen 5.6 MG/ML Injection | SCD | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 1863565 | 5 ML Spinraza 2.4 MG/ML Injection | SY | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 1863560 | nusinersen 12 MG per 5 ML Injection | SY | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2740001 | nusinersen 28 MG per 5 ML Injection | SY | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2739995 | nusinersen 50 MG per 5 ML Injection | SY | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 1863565 | Spinraza 12 MG per 5 ML Injection | SY | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2740004 | Spinraza 28 MG per 5 ML Injection | SY | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
| 2739998 | Spinraza 50 MG per 5 ML Injection | SY | dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94 | 21 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 64406-037-01 | 64406003701 | 1 VIAL, SINGLE-USE in 1 BOX (64406-037-01) / 5 mL in 1 VIAL, SINGLE-USE | 2026-03-27 | No | No | Current |