1. Home
  2. Labeler Index
  3. Biogen
  4. 64406-058
  5. NDC Package Code: 64406-058-01 Spinraza

NDC Package 64406-058-01 Spinraza

Nusinersen Injection, Solution Intrathecal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
64406-058-01
Package Description:
1 VIAL, SINGLE-USE in 1 BOX / 5 mL in 1 VIAL, SINGLE-USE
Product Code:
64406-058
Proprietary Name:
Spinraza
Non-Proprietary Name:
Nusinersen
Substance Name:
Nusinersen
Usage Information:
This medication is used to treat a certain nervous system disorder that can lead to muscle weakness and muscle loss (spinal muscular atrophy). Nusinersen may help improve motor functions (such as crawling, walking).
11-Digit NDC Billing Format:
64406005801
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1863560 - nusinersen 12 MG in 5 ML Injection
  • RxCUI: 1863560 - 5 ML nusinersen 2.4 MG/ML Injection
  • RxCUI: 1863560 - nusinersen 12 MG per 5 ML Injection
  • RxCUI: 1863565 - Spinraza 12 MG in 5 ML Injection
  • RxCUI: 1863565 - 5 ML nusinersen 2.4 MG/ML Injection [Spinraza]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Biogen
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
    • Active Ingredient(s):
  • NUSINERSEN 2.4 mg/mL
    • Pharmacologic Class(es):
  • Antisense Oligonucleotide - [EPC] (Established Pharmacologic Class)
  • Increased Protein Synthesis - [PE] (Physiologic Effect)
  • Oligonucleotides, Antisense - [CS]
  • Survival Motor Neuron-2-directed RNA Interaction - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA209531
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-23-2016
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 64406-058-01?

    The NDC Packaged Code 64406-058-01 is assigned to a package of 1 vial, single-use in 1 box / 5 ml in 1 vial, single-use of Spinraza, a human prescription drug labeled by Biogen. The product's dosage form is injection, solution and is administered via intrathecal form.

    Is NDC 64406-058 included in the NDC Directory?

    Yes, Spinraza with product code 64406-058 is active and included in the NDC Directory. The product was first marketed by Biogen on December 23, 2016 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 64406-058-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 64406-058-01?

    The 11-digit format is 64406005801. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-264406-058-015-4-264406-0058-01