Levetiracetam
Product Images NDC 68258-7089

View Photos of 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 68258-7089). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dispensing 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.

FDA Label Image

Ndc 68258-7089-xx (Ndc 68258 7089 Xx Aurobindo)

Ndc 68258-7089-xx (Ndc 68258 7089 Xx      Aurobindo)
This is a description of a medication produced for Aurobindo Pharma USA, INC. in Dayton, NJ. It is a blue oval shaped biconvex scored tablet with E 10 debossed on it. The bulk source NDC is 65862-0245-08, and the mfr. lot is XXXXXX. The medication is Levitiracetam 250mg, and there are XX tablets in one package with product number 7089-X. The medication should be stored between 68°- 77° F, and kept away from children. It may cause drowsiness or dizziness, so caution should be used when operating machinery or driving. There are instructions to take the tablets orally, whole, and not to chew them, or crush them. They can be taken with or without food, and should be dispensed with a medication guide.*
FDA Label Image

Figure 1 (Levetiracetam Fig1)

Figure 1 (Levetiracetam Fig1)
This is a graph that shows the responder rate (a 250 percent reduction from baseline) in Study 1, with percentages of patients on the Y-axis and the different treatments on the X-axis. There are three bars labeled placebo, levetiracetam 1000 mg/day, and levetiracetam 2000 mg/day. The graph shows that the responder rate is higher with both doses of levetiracetam compared to the placebo. The data indicate that the difference in responder rates is statistically significant versus placebo.*
FDA Label Image

Figure 2 (Levetiracetam Fig2)

Figure 2 (Levetiracetam Fig2)
The figure shows the responder rate in Study 2 where there was a 250% reduction from baseline. The graph shows the percentage of patients who responded to treatment with PledioN-1l), Levetizacetam, or Levetiracetam at different dosage levels. The dosage levels for Levetiracetam were 100 mg/day and 2000 mg/day. The figure also mentions that the results were statistically significant compared to placebo.*
FDA Label Image

Figure 3 (Levetiracetam Fig3)

Figure 3 (Levetiracetam Fig3)
Figure 3 shows the responder rates, which measure the percentage of patients seeing a reduction of more than 50% from baseline, in Study 3. The graph displays the percentage of patients (from 0% to 144%) and the corresponding dosages of the drug Lewtiracstn (180 mg/day) and the placebo (N=104). The asterisk (*) indicates that the drug is statistically significant compared to the placebo.*
FDA Label Image

Figure 4 (Levetiracetam Fig4)

Figure 4 (Levetiracetam Fig4)
The figure 4 demonstrates the responder rate, which indicates the percentage of participants with more than 50% reduction in symptoms from baseline. The group labeled "B" had a responder rate of 44.6%, while the placebo group (N-97) had a responder rate of only 10.6%. The "B" group was statistically significant compared to the placebo group.*
FDA Label Image

Figure 5 (Levetiracetam Fig5)

Figure 5 (Levetiracetam Fig5)
The figure shows the responder rate in terms of a 250% reduction from baseline in PGTC seizure frequency per week. The percentage of patients who achieved this reduction is represented on the Y-axis, ranging from 0% to 100%. The X-axis depicts the different groups of patients, with the placebo group (N=84) on the left and the levetiracetam group (N=79) on the right. The levetiracetam group achieved a statistically significant reduction in PGTC seizures compared to the placebo group.*
FDA Label Image

Chemical Structure (Levetiracetam Str)

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