Lacosamide Solution
Product Images NDC 0121-1012

8 FDA label images from Pai Holdings, Llc Dba Pai Pharma · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Lacosamide (NDC 0121-1012). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pai Holdings, Llc Dba Pai Pharma, 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

Chemical Structure (Lacosamide Novitium 1)

Chemical Structure (Lacosamide Novitium 1)
Chemical structure diagram of lacosamide, displaying its molecular bonds and groups including acetyl, methoxy, amide, and phenyl components.*
FDA Label Image

Figure 1 (Lacosamide Novitium 2)

Figure 1 (Lacosamide Novitium 2)
Bar chart showing the median percent reduction in seizure frequency per 28 days from baseline to maintenance phase by dose across Studies 2, 3, and 4. The x-axis lists placebo and lacosamide doses (200, 400, 600 mg/day), and the y-axis shows seizure reduction percentage. Lacosamide doses show higher median seizure reduction compared to placebo in all studies, with statistical significance indicated.*
FDA Label Image

Figure 2 (Lacosamide Novitium 3)

Figure 2 (Lacosamide Novitium 3)
A line chart titled 'Proportion of Patients by Responder Rate for Lacosamide and Placebo Group in Studies 2, 3, and 4' comparing responder rates (equal to or greater) and worsening between placebo and three lacosamide dosage groups (200 mg/day, 400 mg/day, 600 mg/day). The x-axis shows percent of patients, and the y-axis shows responder rate from -100% to 100% improvement or worsening.*
FDA Label Image

Figure 3 (Lacosamide Novitium 4)

Figure 3 (Lacosamide Novitium 4)
A Kaplan-Meier survival curve comparing the proportion of patients over time (days) between placebo and Lacosamide groups. The graph shows two lines: a solid line for placebo and a dashed line for Lacosamide, with the number of patients at risk listed below. The chart includes statistical data such as p-value, hazard ratio, and confidence interval.*
FDA Label Image

5 mL Lidding (Lacosamide Novitium 5)

5 mL Lidding (Lacosamide Novitium 5)
Label for Lacosamide Oral Solution USP 50 mg/5 mL by PAI Holdings, LLC dba PAI Pharma. The label states it delivers 5 mL, includes the NDC 0121-1012-05, and indicates the package is not child-resistant. The label also includes a barcode and a direction to see the insert.*
FDA Label Image

10 mL Lidding (Lacosamide Novitium 6)

10 mL Lidding (Lacosamide Novitium 6)
Label for Lacosamide Oral Solution USP, 100 mg/10 mL delivered in a 10 mL quantity. The label includes the NDC code 0121-2024-10 and notes that the package is not child-resistant. It is marked Rx Only and packaged by PAI Pharma in Greenville, SC. The label advises to see the insert for more information.*
FDA Label Image

15 mL Lidding (Lacosamide Novitium 7)

15 mL Lidding (Lacosamide Novitium 7)
Label for Lacosamide Oral Solution USP 150 mg/15 mL, an oral solution. The label states it delivers 15 mL and includes a barcode. The product is marked as Schedule V controlled substance (C V). It is packaged by PAI Pharma, Greenville, SC, and is labeled as Rx only and not child-resistant.*
FDA Label Image

20 mL Lidding (Lacosamide Novitium 8)

20 mL Lidding (Lacosamide Novitium 8)
Lacosamide Oral Solution USP 200 mg/20 mL circular label showing delivery volume and NDC 0121-4048-74. The label includes a barcode, notes that the package is not child-resistant, and states Rx only. Packaged by PAI Pharma, Greenville, SC 29605.*

* 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.