Lacosamide Injection
Product Images NDC 68083-480

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Lacosamide (NDC 68083-480). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Gland Pharma Limited, 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

Lacosamide-spl-structure (Lacosamide Spl Structure)

Chemical structure of lacosamide, depicting its molecular framework including the acetyl, amide, and benzyl groups associated with the active ingredient lacosamide injection.*

FDA Label Image

Lacosamide-spl-figure-1 (Lacosamide Spl Figure 1)

A bar chart titled 'Median Percent Reduction in Seizure Frequency per 28 days from Baseline to the Maintenance Phase by Dose' showing seizure reduction percentages across three studies comparing placebo and varying doses of Lacosamide injection (200, 400, 600 mg/day). Each study displays higher median percent seizure reductions in the Lacosamide groups versus placebo, with statistical significance indicated for several doses.*

FDA Label Image

Lacosamide-spl-figure-2 (Lacosamide Spl Figure 2)

A chart titled 'Proportion of Patients by Responder Rate for Lacosamide and Placebo Groups in Studies 2, 3, and 4.' It plots responder rate (equal to or greater) on the vertical axis (ranging from -100% worsening to 100% improvement) against percent of patients on the horizontal axis (ranging from 100% to 0%). Multiple lines represent placebo and lacosamide doses (200 mg/day, 400 mg/day, 600 mg/day) with corresponding sample sizes for each group.*

FDA Label Image

Lacosamide-spl-figure-3 (Lacosamide Spl Figure 3)

A Kaplan-Meier survival curve comparing Lacosamide versus placebo over time in days. The vertical axis represents the percent of patients, and the graph shows higher survival probability over time for Lacosamide patients compared to placebo. The chart includes a legend, number at risk tables, and statistical data like p-value and hazard ratio.*

FDA Label Image

Lacosamide-spl-container (Lacosamide Spl Container)

Label for Lacosamide Injection, USP 10 mg/mL in a 20 mL single-dose vial. The label indicates a total of 200 mg per 20 mL vial for intravenous use only. It is manufactured by Gland Pharma Limited in India and includes dosage instructions, a barcode, and storage information.*

FDA Label Image

Lacosamide-spl-carton (Lacosamide Spl Carton)

Label for Lacosamide Injection, USP 200 mg/20 mL (10 mg/mL) intravenous injection by Gland Pharma Limited. The package contains 10 single-dose vials of 20 mL solution each for infusion. Instructions note to dispense the enclosed Medication Guide to each patient. Label includes storage and inactive ingredient information as well as manufacturer details with 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.