Prescription drug · NDA
Spinraza (Nusinersen) NDC 64406-058
Nusinersen 2.4 mg/mL · Injection, Solution · Intrathecal · Biogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64406-058-01 | 6440600580164406005801 | 1 VIAL, SINGLE-USE in 1 BOX (64406-058-01) / 5 mL in 1 VIAL, SINGLE-USEMarketed from Dec 23, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Spinraza
- Generic name (nonproprietary)
- nusinersen
- Active ingredients
- Nusinersen — 2.4 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intrathecal
- Labeler
- Biogen Inc.NDC labeler code 64406
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209531
- Marketing start
- Listing expires
- Other FDA classes
- Increased Protein Synthesis (Physiologic effect)Antisense (Chemical structure)
- Identifiers
- Product ID 64406-058_cb572584-c0fd-42aa-b6d1-6dd8260028b5SPL ID cb572584-c0fd-42aa-b6d1-6dd8260028b5SPL set ID dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94RxCUI 1863560, 1863565, 2739995, 2739998, 2740001, 2740004UNII 5Z9SP3X666
- Pharmacologic class
- Antisense Oligonucleotide; Survival Motor Neuron-2-directed RNA Interaction
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N464406005801followed by a unit qualifier and the quantityPackage 64406-0058-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 64406-058
- What is NDC 64406-058?
- 64406-058 is the product NDC for Spinraza (nusinersen), Nusinersen 2.4 mg/mL injection, solution, listed with the FDA by Biogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Spinraza (Nusinersen).
- What is the active ingredient?
- Nusinersen.
- Who is the labeler?
- Biogen Inc., NDC labeler code 64406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Spinraza?
- 2 other product NDCs are listed under this name. See all Spinraza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Spinraza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Spinrazanusinersen | Nusinersen 5.6 mg/mL | Injection, SolutionIntrathecal | Biogen Inc. | 64406-036 | 64406-0036-01 |
| Spinrazanusinersen | Nusinersen 10 mg/mL | Injection, SolutionIntrathecal | Biogen Inc. | 64406-037 | 64406-0037-01 |
Other NDCs under NDA 209531
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Spinrazanusinersen | Nusinersen 5.6 mg/mL | Injection, SolutionIntrathecal | Biogen Inc. | 64406-036 |
| Spinrazanusinersen | Nusinersen 10 mg/mL | Injection, SolutionIntrathecal | Biogen Inc. | 64406-037 |