Levetiracetam Tablet, Film Coated
Product Images NDC 55154-0288

11 FDA label images from Cardinal Health 107, 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 55154-0288). 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.

FDA Label Image

500mg Bag Label (100d7618 B8e6 43f5 A4e2 6fd728de9d3f 00)

500mg Bag Label (100d7618 B8e6 43f5 A4e2 6fd728de9d3f 00)
Levetiracetam Tablets USP 500 mg film-coated tablets packaging label. The label indicates a package containing 10 tablets, each white, film-coated, modified capsule-shaped with specific debossing. Manufactured by Mylan Pharmaceuticals Inc. and distributed by Safecor Health LLC and Cardinal Health, with storage instructions and usage warnings included on the label.*
FDA Label Image

Figure 1: Responder Rate (≥ 50% Reduction From Baseline) In Study 1 (Image 01)

Figure 1: Responder Rate (≥ 50% Reduction From Baseline) In Study 1 (Image 01)
Bar chart showing the percentage of patients by treatment group: Placebo (7.4%), Levetiracetam Tablets 1000 mg/day (37.1%), and Levetiracetam Tablets 3000 mg/day (39.6%). Asterisks indicate statistically significant differences versus placebo.*
FDA Label Image

Levetiracetam Structural Formula (Image 05)

Levetiracetam Structural Formula (Image 05)
Chemical structure diagram of levetiracetam, showing its molecular composition with a five-membered lactam ring and side chains including ethyl and amide groups.*
FDA Label Image

Pedatric Patient Dose Calculation (Image 06)

Pedatric Patient Dose Calculation (Image 06)
A text panel showing a formula to calculate total daily dose in milliliters per day based on daily dose in mg/kg/day, patient weight in kilograms, and concentration of 100 mg/mL.*
FDA Label Image

Creatinine Clearance Calculation (Image 07)

Creatinine Clearance Calculation (Image 07)
A mathematical formula illustrating creatinine clearance (CLcr), calculated using patient age, weight, serum creatinine, with an adjustment factor of 0.85 for female patients. This formula is often used in clinical contexts related to drug dosing for Levetiracetam tablets.*
FDA Label Image

Creatinine Clearance Bsa Calculation (Image 08)

Creatinine Clearance Bsa Calculation (Image 08)
An instructional diagram illustrating the formula to calculate creatinine clearance (CLcr) normalized to body surface area. The equation shows creatinine clearance (mL/min/1.73 m²) equals measured clearance (mL/min) divided by the subject's body surface area (m²), multiplied by 1.73.*
FDA Label Image

Figure 2: Responder Rate (≥ 50% Reduction From Baseline) In Study 2: Period A (Image 09)

Figure 2: Responder Rate (≥ 50% Reduction From Baseline) In Study 2: Period A (Image 09)
A bar chart comparing the percentage of patients among three groups: Placebo, Levetiracetam Tablets 1000 mg/day, and Levetiracetam Tablets 2000 mg/day. The chart shows increasing patient percentages with higher doses, with Levetiracetam 2000 mg/day having the highest percentage, followed by 1000 mg/day, and lowest for placebo.*
FDA Label Image

Figure 3: Responder Rate (≥ 50% Reduction From Baseline) In Study 3 (Image 10)

Figure 3: Responder Rate (≥ 50% Reduction From Baseline) In Study 3 (Image 10)
This bar chart compares the percentage of patients between two groups: those receiving a placebo and those receiving Levetiracetam Tablets at 3000 mg/day. The chart shows the placebo group with 14.4% and the Levetiracetam group with 39.4%, indicating a statistically significant difference versus placebo.*
FDA Label Image

Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Image 11)

Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Image 11)
A bar chart comparing the percentage of patients between two groups: Placebo (N=97) and Levetiracetam Tablets (N=101). The chart shows 19.6% for the placebo group and 44.6% for the Levetiracetam tablets group, with an asterisk denoting statistical significance 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 12)

Figure 5: Responder Rate For All Patients Ages 1 Month To < 4 Years (≥ 50% Reduction From Baseline) In Study 5 (Image 12)
A bar chart comparing the percentage of patients for placebo versus Levetiracetam Tablets. The graph shows 19.6% of patients for placebo (N=51) and 43.1% for Levetiracetam Tablets (N=58), with a statistical significance indicated between groups.*
FDA Label Image

Figure 6: Responder Rate (≥ 50% Reduction From Baseline) In Pgtc Seizure Frequency Per Week In Study 7 (Image 13)

Figure 6: Responder Rate (≥ 50% Reduction From Baseline) In Pgtc Seizure Frequency Per Week In Study 7 (Image 13)
A bar graph comparing the percentage of patients between a placebo group (N=84) and a levetiracetam tablets group (N=79). The graph shows 45.2% for placebo and 72.2% for levetiracetam, with a note indicating statistical significance between the two groups.*

* 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.