Levetiracetam Tablet, Film Coated
Product Images NDC 87441-046

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Levetiracetam (NDC 87441-046). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Solutions, 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.

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Levetiracetam 500 mg (8744104601 Levetiracetam 500 mg)

Levetiracetam 500 mg (8744104601 Levetiracetam 500 mg)
This text contains information about Levetiracetam tablets in 500 mg strength, with NDC 87441-046-01. It includes dosage and use instructions for pharmacists, storage recommendations, lot number, expiration date, and the repackaged and distributed information. The medication is prescribed for use and should be kept in a tight, light-resistant container at controlled room temperature.*
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Table 1 (Table 1)

Table 1 (Table 1)
This text provides a guideline for dosage adjustment based on creatinine clearance levels for different categories such as normal, mild, moderate, and severe impairment. It also includes special dosing recommendations for end-stage renal disease (ESRD) patients undergoing dialysis, suggesting a supplemental dose post-dialysis.*
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Figure 1: Responder Rate (≥50% Reduction From Baseline) In Study 1 (Levetiracetam Fig1)

Figure 1: Responder Rate (≥50% Reduction From Baseline) In Study 1 (Levetiracetam Fig1)
This description provides information on the responder rate (250% reduction from baseline) shown in Study 1. The data presented includes various percentages ranging from 2% to 39.6%. The results indicate that a certain treatment was statistically significant compared to the placebo group.*
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Figure 2: Responder Rate (≥50% Reduction From Baseline) In Study 2: Period A (Levetiracetam Fig2)

Figure 2: Responder Rate (≥50% Reduction From Baseline) In Study 2: Period A (Levetiracetam Fig2)
This is a description of a study comparing the Responder Rate (250% Reduction from Baseline) in Study 2 during Period A. The data includes percentages of responders for different treatment groups: Placebo, Levetiracetam 1000 mg/day, and Levetiracetam 2000 mg/day. It highlights a statistically significant difference in response rates between one of the Levetiracetam groups and the Placebo group.*
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Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3 (Levetiracetam Fig3)

Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3 (Levetiracetam Fig3)
This description indicates the Responder Rate with over 50% reduction from baseline in Study 3. The results show a 45% responder rate for those on Levetiracetam 3000 mg/day compared to 39.4% for the placebo group. These results were statistically significant, highlighting the effectiveness of Levetiracetam compared to the placebo in this study.*
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Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Levetiracetam Fig4)

Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Levetiracetam Fig4)
This text presents data on the Responder Rate (50% Reduction from Baseline) in Study 4, comparing the placebo group (N=97) to the Levetiracetam group (N=101). The Responder Rate was 44.6% for Levetiracetam and 19.6% for placebo. The Levetiracetam group exhibited a statistically significant improvement in responder rate compared to the placebo group.*
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Figure 5: Responder Rate For All Patients Ages 1 Month To < 4 Years (≥ 50% Reduction From Baseline) In Study 5 (Levetiracetam Fig5)

Figure 5: Responder Rate For All Patients Ages 1 Month To < 4 Years (≥ 50% Reduction From Baseline) In Study 5 (Levetiracetam Fig5)
This text provides information on the Responder Rate for all patients aged 1 month to < 4 years showing more than a 50% reduction from baseline in Study 5. The data shows Placebo (451) and Lovetracatam (4-58) and indicates that Lovetracatam has a statistically significant difference when compared to placebo.*
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Figure 6: Responder Rate (≥50% Reduction From Baseline) In Pgtc Seizure Frequency Per Week In Study 7 (Levetiracetam Fig6)

Figure 6: Responder Rate (≥50% Reduction From Baseline) In Pgtc Seizure Frequency Per Week In Study 7 (Levetiracetam Fig6)
This text presents data on the Responder Rate (250% Reduction from Baseline) in PGTC Seizure Frequency per Week in Study 7. The graph shows the percentage of responders in the placebo and Levetiracetam groups, with Levetiracetam demonstrating a significant improvement in reducing seizures compared to placebo. The study included 84 patients in the placebo group and 79 patients in the Levetiracetam group.*
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Chemical Structure (Levetiracetam Str)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.