Spinraza Injection, Solution
Product Images NDC 64406-058

Product Visual Gallery

This gallery contains 10 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 0021 01)

Chemical structure of Nusinersen, the active ingredient in Spinraza injection solution. The diagram shows the molecular arrangement and bonding of nucleotides and other chemical groups characterizing this compound.*

FDA Label Image

Figure 1 (Spi02 0021 02)

A bar chart comparing percent of subjects between Spinraza Low Dose Regimen and Sham-control groups based on changes in Total Motor Milestone Score. The x-axis represents change ranging from death to 19, with labels for worsening and improvement, and the y-axis shows percentage of subjects.*

FDA Label Image

Figure 2 (Spi02 0021 03)

A Kaplan-Meier survival curve chart showing the probability of ventilation-free survival over time in weeks for Spinraza low dose regimen compared to sham treatment. The y-axis represents the probability of ventilation-free survival from 0.0 to 1.0, and the x-axis shows time up to 64 weeks. The Spinraza low dose regimen curve is solid, and the sham curve is dashed, indicating higher ventilation-free survival probability in the Spinraza group. The chart includes a hazard ratio of 0.53 comparing Spinraza low dose regimen with sham.*

FDA Label Image

Figure 3 (Spi02 0021 04)

A line chart comparing LSmeans change in HFMSE from baseline over 15 months between Spinraza low dose regimen and sham control groups. The x-axis represents months (0 to 15), and the y-axis measures change in HFMSE. The Spinraza group shows an increasing trend, while the sham group trends downward after 6 months.*

FDA Label Image

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

Packaging label for Spinraza (nusinersen) injection, 12 mg/5 mL (2.4 mg/mL) sterile solution for intrathecal use only. The label shows storage instructions, active ingredient details, manufacturer Biogen Inc., and barcode. The product is presented as a single-dose vial with Rx only designation.*

FDA Label Image

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

Label for Spinraza (nusinersen) injection, 12 mg per 5 mL (2.4 mg/mL) solution for intrathecal use. The label includes the NDC number 64406-058-01 and states it is manufactured for Biogen Inc. It also shows placeholders for lot number and expiration date.*

FDA Label Image

Principal Display Panel (Spinraza 28 mg/5 mL Carton Label)

Packaging label for Spinraza (nusinersen) injection, 28 mg per 5 mL (5.6 mg/mL) sterile solution for intrathecal use. The label indicates a single-dose vial, Rx only, manufactured by Biogen Inc. It includes storage instructions, ingredient details, and manufacturer contact information. The design features purple and white color tones with the Biogen logo and barcode.*

FDA Label Image

Principal Display Panel (Spinraza 28 mg/5 mL Vial Label)

Spinraza (nusinersen) injection label displaying 28 mg/5 mL (5.6 mg/mL) strength. It is an intrathecal injection manufactured for Biogen Inc. The label includes the NDC code 64406-036-01, lot number, expiration date, and a barcode.*

FDA Label Image

Principal Display Panel (Spinraza 50 mg/5 mL Carton Label)

Packaging label for Spinraza (nusinersen) injection, 50 mg/5 mL (10 mg/mL), a sterile solution for intrathecal use. The label includes dosage strength, storage instructions to refrigerate at 2°C to 8°C, and manufacturer information for Biogen Inc. It indicates a single-dose vial and contains detailed composition and handling information. The label features blue and white colors with barcodes and regulatory statements.*

FDA Label Image

Principal Display Panel (Spinraza 50 mg/5 mL Vial Label)

Label for Spinraza (nusinersen) injection, 50 mg/5 mL concentration (10 mg/mL). This intrathecal injection solution is manufactured for Biogen Inc. The label includes NDC 64406-037-01, lot number, expiration date, and a barcode.*

* 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.