Spinraza
- Product NDC
- 64406-058
- 11-digit product format
- 644060058
- Labeler code
- 64406
- Product ID
- 64406-058_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
- 2016-12-23
- Substance
- NUSINERSEN
- Active strength
- 2.4 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 table| Ingredient | Strength |
|---|
| NUSINERSEN | 2.4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5Z9SP3X666 |
| Rxcui | 1863560, 1863565, 2739995, 2739998, 2740001, 2740004 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64406-058-01 | Spinraza | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 21 |
| 64406-058-01 | Spinraza | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 5 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64406-058 | SPINRAZA (NUSINERSEN) INJECTION, SOLUTION [BIOGEN] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240423_dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64406-058-01 | 64406005801 | 1 VIAL, SINGLE-USE in 1 BOX (64406-058-01) / 5 mL in 1 VIAL, SINGLE-USE | 2016-12-23 | 0000-00-00 | No | No | Current |