Levetiracetam Injection, Solution, Concentrate
Product Images NDC 67457-790

11 FDA label images from Mylan Institutional Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Levetiracetam (NDC 67457-790). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Institutional Llc, 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

Pediatric Patient Formula (Export 02)

Pediatric Patient Formula (Export 02)
A formula for calculating total daily dose in milliliters per day is shown. The equation divides the product of daily dose in milligrams per kilogram per day and patient weight in kilograms by 100 mg/mL, the concentration of levetiracetam injection solution concentrate.*
FDA Label Image

Creatinine Clearance Formula (Export 01)

Creatinine Clearance Formula (Export 01)
An equation panel showing the formula for calculating creatinine clearance (CLcr). The formula is given as [(140 - age in years) × weight in kg] divided by [72 × serum creatinine in mg/dL], multiplied by 0.85 for female patients. This text is typically found in clinical or pharmacokinetic contexts.*
FDA Label Image

Clcr Is Adjusted For Body Surface Area Formula (Export 00)

Clcr Is Adjusted For Body Surface Area Formula (Export 00)
A mathematical formula image showing a calculation for creatinine clearance (CLcr) normalized to body surface area (BSA). The formula expresses CLcr (mL/min/1.73 m2) as the product of the ratio of CLcr (mL/min) to BSA of the subject (m2), multiplied by 1.73. This is not product-specific but relates to pharmacokinetic or clinical calculation.*
FDA Label Image

Levetiracetam Structural Formula (Image 01)

Levetiracetam Structural Formula (Image 01)
Chemical structure diagram of levetiracetam, showing its molecular bonds and layout including a pyrrolidone ring attached to an ethyl side chain and an amide group.*
FDA Label Image

Figure 1: Responder Rate In Study 1 (Image 03)

Figure 1: Responder Rate  In Study 1 (Image 03)
A bar chart titled 'Responder Rate (≥50% Reduction from Baseline) in Study 2: Period A' showing the percentage of patients responding to treatment. It compares placebo (6.3%), levetiracetam 1000 mg/day (20.8%), and levetiracetam 2000 mg/day (35.2%). The chart indicates statistical significance of levetiracetam groups versus placebo.*
FDA Label Image

Figure 2: Responder Rate In Study 2: Period A (Image 04)

Figure 2: Responder Rate In Study 2: Period A (Image 04)
A bar chart showing responder rates (≥ 50% reduction from baseline) in Study 4. The y-axis represents percentage of patients from 0% to 45%. Two bars compare placebo (19.6%, N=97) and levetiracetam (44.6%, N=101), with levetiracetam showing a higher responder rate.*
FDA Label Image

Figure 3: Responder Rate In Study 3 (Image 05)

Figure 3: Responder Rate In Study 3 (Image 05)
Bar graph titled 'Responder Rate for All Patients Ages 1 Month to < 4 Years (≥ 50% Reduction from Baseline) in Study 5' depicting percentage of patients responding in two groups: Placebo (N=51) with 19.6% responders and Levetiracetam (N=58) with 43.1% responders. An asterisk denotes statistical significance versus placebo.*
FDA Label Image

Figure 4: Responder Rate In Study 4 (Image 06)

Figure 4: Responder Rate In Study 4 (Image 06)
Bar chart showing the responder rate (≥50% reduction from baseline) in partial generalized tonic-clonic (PGTC) seizure frequency per week in Study 7. The chart compares Placebo (N=84) with 45.2% responders and Levetiracetam (N=79) with 72.2% responders, indicating a statistically significant difference favoring Levetiracetam.*
FDA Label Image

Figure 5: Responder Rate For All Patients 1 Month To &lt; 4 Years In Study 5 (Image 07)

Figure 5: Responder Rate For All Patients 1 Month To &lt; 4 Years In Study 5 (Image 07)
Bar chart titled 'Responder Rate (≥50% Reduction from Baseline) in Study 3' depicting the percentage of patients responding to treatment. One bar shows 14.4% responders in the placebo group (N=104), and the other shows 39.4% responders at levetiracetam 3000 mg/day (N=180), with an asterisk indicating statistical significance versus placebo.*
FDA Label Image

Figure 6: Responder Rate In Pgtc Seizure Frequency Per Week In Study 7 (Image 08)

Figure 6: Responder Rate In Pgtc Seizure Frequency Per Week In Study 7 (Image 08)
A bar chart comparing the percentage of patients between two groups: Placebo (N=84) at 45.2% and Levetiracetam (N=79) at 72.2%. The chart notes a statistically significant difference between the Levetiracetam group and placebo.*
FDA Label Image

Levetiracetam Injection Carton Label (Image 02)

Levetiracetam Injection Carton Label (Image 02)
Bar graph showing responder rates (≥50% reduction from baseline) in Study 1 comparing placebo and levetiracetam at daily doses of 1000 mg and 3000 mg. The y-axis represents the percentage of patients, with placebo at 7.4%, levetiracetam 1000 mg/day at 37.1%, and levetiracetam 3000 mg/day at 39.6%. Both levetiracetam groups show statistically significant improvements versus placebo.*

* 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.