Levetiracetam
Product Images NDC 10135-695

7 FDA label images from Marlex Pharmaceuticals Inc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Levetiracetam (NDC 10135-695). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Marlex Pharmaceuticals 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.

Product Images & Figures Index

FDA Label Image

The Following Structural Formula For Levetiracetam Usp, A Single Enantiomer, Is ( ) (s) α Ethyl 2 Oxo 1-pyrrolidine Acetamide, Its Molecular Formula Is C8h14n2o2 And Its Molecular Weight Is 170.21. Levetiracetam Is Chemically Unrelated To Existing Antiepileptic Drugs (aeds). (Levetiracetam Oral Solution Usp 01)

The Following Structural Formula For Levetiracetam Usp, A Single Enantiomer, Is ( ) (s) α Ethyl 2 Oxo 1-pyrrolidine Acetamide, Its Molecular Formula Is C8h14n2o2 And Its Molecular Weight Is 170.21. Levetiracetam Is Chemically Unrelated To Existing Antiepileptic Drugs (aeds). (Levetiracetam Oral Solution Usp 01)
Chemical structure of levetiracetam showing its molecular arrangement with a pyrrolidone ring, an ethyl side chain, and an amide group.*
FDA Label Image

Figure 1: Responder Rate (≥50% Reduction From Baseline) In Study 1 (Levetiracetam Oral Solution Usp 02)

Figure 1: Responder Rate (≥50% Reduction From Baseline) In Study 1 (Levetiracetam Oral Solution Usp 02)
A bar graph showing the percentage of patients responding to different treatments: placebo, Levetiracetam 1000 mg/day, and Levetiracetam 3000 mg/day. The y-axis represents the percentage of patients, with the placebo group at 7.4%, Levetiracetam 1000 mg/day at 37.1%, and Levetiracetam 3000 mg/day at 39.6%. The graph indicates statistically significant differences versus placebo for both Levetiracetam doses.*
FDA Label Image

Figure 2: Responder Rate (≥50% Reduction From Baseline) In Study 2: Period A (Levetiracetam Oral Solution Usp 03)

Figure 2: Responder Rate (≥50% Reduction From Baseline) In Study 2: Period A (Levetiracetam Oral Solution Usp 03)
Bar chart showing the percentage of patients responding to treatment, comparing placebo and two doses of levetiracetam (1000 mg/day and 2000 mg/day). The chart highlights a statistically significant higher response rate in both levetiracetam groups compared to placebo.*
FDA Label Image

Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3 (Levetiracetam Oral Solution Usp 04)

Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3 (Levetiracetam Oral Solution Usp 04)
A bar chart comparing the percentage of patients between a placebo group and a Levetiracetam group (3000 mg/day). The placebo group shows 14.4% of patients, while the Levetiracetam group shows 39.4%, with a note indicating statistical significance versus placebo.*
FDA Label Image

Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Levetiracetam Oral Solution Usp 05)

Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Levetiracetam Oral Solution Usp 05)
A vertical bar chart comparing the percentage of patients in two groups: Placebo (N=97) with 19.6%, and Levetiracetam (N=101) with 44.6%. The chart indicates a statistically significant difference between Levetiracetam and placebo groups.*
FDA Label Image

Figure 6: Responder Rate (≥ 50 % Reduction From Baseline) In Pgtc Seizure Frequency Per Week In Study 7 (Levetiracetam Oral Solution Usp 06)

Figure 6: Responder Rate (≥ 50 % Reduction From Baseline) In Pgtc Seizure Frequency Per Week In Study 7 (Levetiracetam Oral Solution Usp 06)
Bar graph comparing the percentage of patients between placebo (45.2%) and Levetiracetam (72.2%) groups. The graph indicates a statistically significant difference between Levetiracetam and placebo, as noted by an asterisk above the Levetiracetam bar. Sample sizes are shown as N=84 for placebo and N=79 for Levetiracetam.*
FDA Label Image

Principal Display Panel (473 mL Bottle LabelNDC 10135-0695-08LevetiracetamOral Solution, USP100 mg/mLDispense accompanyingMedication Guideto each patient.Rx only16 fl oz (473 mL))

Principal Display Panel (473 mL Bottle LabelNDC 10135-0695-08LevetiracetamOral Solution, USP100 mg/mLDispense accompanyingMedication Guideto each patient.Rx only16 fl oz (473 mL))
Label for Levetiracetam Oral Solution USP, 100 mg/mL, manufactured by Marlex Pharmaceuticals Inc. The label shows the product name, concentration, volume of 473 mL, and instructions including storage conditions, dispensing requirements, and a warning to keep out of reach of children. The product is Rx only and includes a barcode and the NDC 10135-695-08.*

* 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.