Levetiracetam Tablet, Film Coated
Product Images NDC 55154-5699

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Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Levetiracetam (NDC 55154-5699). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cardinal Health 107, 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.

Product Images & Figures Index

FDA Label Image

Formula Calculation For Patients With Renal Impairment (A518c4f5 8b66 4770 B971 3534d581ca99 02)

Formula Calculation For Patients With Renal Impairment (A518c4f5 8b66 4770 B971 3534d581ca99 02)
An illustration of the creatinine clearance formula (CLcr) that calculates renal function. The formula uses age in years, weight in kilograms, and serum creatinine in mg/dL, with an adjustment factor of 0.85 for female patients.*
FDA Label Image

Then Clcr Is Adjusted For Body Surface Area (bsa) As Follows (A518c4f5 8b66 4770 B971 3534d581ca99 03)

Then Clcr Is Adjusted For Body Surface Area (bsa) As Follows (A518c4f5 8b66 4770 B971 3534d581ca99 03)
A mathematical formula depicting the calculation of creatinine clearance (CLcr) adjusted for body surface area (BSA). It shows CLcr in mL/min divided by the subject's BSA in square meters, multiplied by 1.73, aligning CLcr to a standardized BSA. This formula is relevant in pharmacokinetics for drugs like levetiracetam.*
FDA Label Image

Levetiracetam Structural Formula (A518c4f5 8b66 4770 B971 3534d581ca99 04)

Levetiracetam Structural Formula (A518c4f5 8b66 4770 B971 3534d581ca99 04)
Chemical structure of levetiracetam showing a pyrrolidone ring with substituents including an ethyl group and an amide group attached to the central carbon atom.*
FDA Label Image

B00f2ee7 8be3 4007 Ae9e 38060f5ec377 00

B00f2ee7 8be3 4007 Ae9e 38060f5ec377 00
Levetiracetam tablets, USP 500 mg film-coated tablets in a unit dose package containing 10 tablets. The label includes dosing instructions references, storage conditions at controlled room temperature, RX only status, and warning that the package is not child resistant. The product is manufactured for Mylan Pharmaceuticals, distributed by Mylan Institutional Inc. and Cardinal Health, with manufacturing in India.*
FDA Label Image

Levetiracetam Oral Solution Weight-based Dosing Calculation For Pediatric Patients (Image 01)

Levetiracetam Oral Solution Weight-based Dosing Calculation For Pediatric Patients (Image 01)
A formula illustrating how to calculate total daily dose in mL/day for Levetiracetam oral solution. The formula divides the product of daily dose in mg/kg/day and patient weight in kg by the concentration 100 mg/mL.*
FDA Label Image

Figure 1: Responder Rate (≥ 50% Reduction From Baseline) In Study 1 (Image 02)

Figure 1: Responder Rate (≥ 50% Reduction From Baseline) In Study 1 (Image 02)
Bar chart displaying the percentage of patients for placebo and two dosages of Levetiracetam tablets (1000 mg/day and 3000 mg/day). The chart shows significantly higher percentages for both Levetiracetam groups compared to placebo, with values of 7.4% for placebo, 37.1% for 1000 mg/day, and 39.6% for 3000 mg/day, indicating statistical significance versus placebo.*
FDA Label Image

Figure 3: Responder Rate (≥ 50% Reduction From Baseline) In Study 3 (Image 03)

Figure 3: Responder Rate (≥ 50% Reduction From Baseline) In Study 3 (Image 03)
A bar graph illustrating the percentage of patients in three groups: placebo (6.3%), levetiracetam 1000 mg/day (20.8%), and levetiracetam 2000 mg/day (35.2%). The chart highlights statistically significant differences versus placebo among patients receiving levetiracetam tablets.*
FDA Label Image

Figure 2: Responder Rate (≥ 50% Reduction From Baseline) In Study 2: Period A (Image 04)

Figure 2: Responder Rate (≥ 50% Reduction From Baseline) In Study 2: Period A (Image 04)
A bar graph comparing the percentage of patients for placebo versus Levetiracetam tablets at 300 mg/day. The graph shows 14.4% for placebo (N=104) and 39.4% for Levetiracetam (N=180), with a notation indicating statistical significance versus placebo.*
FDA Label Image

Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Image 05)

Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Image 05)
A bar graph comparing the percentage of patients between placebo and Levetiracetam tablets groups. The graph shows approximately 19.6% for the placebo group (N=97) and 44.6% for the Levetiracetam tablets group (N=101). A note indicates the difference is statistically significant versus placebo.*
FDA Label Image

Figure 5: Responder Rate For All Patients Ages 1 Month To < 4 Years (≥ 50% Reduction From Baseline) In Study 5 (Image 06)

Figure 5: Responder Rate For All Patients Ages 1 Month To < 4 Years (≥ 50% Reduction From Baseline) In Study 5 (Image 06)
Bar chart comparing the percentage of patients responding to Placebo (19.6%) versus Levetiracetam Tablets (43.1%). The chart indicates a statistically significant difference between the two groups, with Levetiracetam showing a higher response rate.*
FDA Label Image

Figure 6: Responder Rate (≥ 50% Reduction From Baseline) In Pgtc Seizure Frequency Per Week In Study 7 (Image 07)

Figure 6: Responder Rate (≥ 50% Reduction From Baseline) In Pgtc Seizure Frequency Per Week In Study 7 (Image 07)
A bar graph comparing the percentage of patients showing results between Placebo and Levetiracetam Tablets groups. The graph shows 45.2% for Placebo (N=84) and 72.2% for Levetiracetam Tablets (N=79), with an asterisk noting statistical significance 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.