Spinraza Injection, Solution
Product Images NDC 64406-058

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Spinraza (NDC 64406-058). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biogen Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Structural Formula (Spi02 0014 01)

Chemical structure diagram showing multiple monomer units forming the active ingredient Nusinersen, used in Spinraza injections. The detailed molecular composition includes sugar, phosphate, and base components specific to the antisense oligonucleotide.*

FDA Label Image

Figure 1 (Spi02 0014 02)

A bar chart comparing the percent of subjects in Spinraza and sham-control groups by change in total motor milestone score. The x-axis shows score changes from death through positive and negative milestones, with better outcomes to the right and worse to the left. Black bars represent Spinraza group data, gray bars represent sham-control group data, displaying distribution of motor milestone changes.*

FDA Label Image

Figure 2 (Spi02 0014 03)

A Kaplan-Meier survival curve chart showing the probability of ventilation-free survival over time (weeks) comparing Spinraza and sham treatment groups. The solid line represents Spinraza, and the dashed line represents sham, with data points and the number of subjects at risk shown below the x-axis. The chart includes a hazard ratio of 0.53 favoring Spinraza.*

FDA Label Image

Figure 3 (Spi02 0014 04)

A line graph depicting LSmeans change in HFMSE from baseline over 15 months, comparing Spinraza (solid line) and Sham (dashed line) treatment groups. The x-axis represents time in months, and the y-axis shows the LSmeans change in HFMSE, with error bars displayed for each data point.*

FDA Label Image

Principal Display Panel (Spinraza 12mg/5ml Carton Label)

Spinraza (nusinersen) injection label shows a sterile solution for intrathecal injection with a strength of 12 mg per 5 mL (2.4 mg/mL). The label includes the NDC 64406-058-01 and states it is for single-use vial only, with unused portions to be discarded. The product is labeled Rx Only.*

FDA Label Image

Principal Display Panel (Spinraza 12mg/5ml Vial Label)

Label for Spinraza (nusinersen) injection, 12 mg/5 mL solution (2.4 mg/mL) for intrathecal use. The label includes the NDC 64406-058-01 and mentions lot, expiration, and manufacturing information areas. The product is labeled by Biogen Inc.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.