Gabapentin
Product Images NDC 58517-060

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 58517-060). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by New Horizon Rx Group, 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

Chemical Structure (01e45240 Figure 01)

Chemical structure of Gabapentin showing its molecular arrangement with a cyclohexane ring, an amino group (CH2NH2), and a carboxymethyl side group (CH2CO2H).*

FDA Label Image

Figure 1. Weekly Mean Pain Scores (observed Cases In Itt Population): Study 1 (01e45240 Figure 02)

Line graph depicting mean pain score over 8 weeks comparing placebo and Gabapentin 3600 mg/day. The x-axis represents time in weeks, including a 4-week dose titration period and a 4-week fixed dose period. The y-axis shows the mean pain score, with Gabapentin showing a decreasing trend compared to placebo. Statistical significance (p < 0.01) is indicated for several weeks.*

FDA Label Image

Figure 2.  Weekly Mean Pain Scores (observed Cases In Itt Population): Study 2 (01e45240 Figure 03)

A line graph showing mean pain score over a 7-week period for placebo and Gabapentin 1800 mg/day and 2400 mg/day groups. The x-axis represents weeks from baseline, and the y-axis shows mean pain scores. The graph indicates a dose titration period followed by a fixed dose period, with Gabapentin groups demonstrating a statistically significant reduction in pain compared to placebo throughout the study.*

FDA Label Image

Figure 3. Proportion Of Responders (patients With ≥50% Reduction In Pain Score) At Endpoint: Controlled Phn Studies (01e45240 Figure 04)

A bar chart comparing the percentage of responders at endpoint in two studies. Study 1 compares placebo (PBO) and Gabapentin (GBP) 3600 mg, showing higher responder rates for GBP (29%) versus PBO (12%). Study 2 compares PBO, GBP 1800 mg, and GBP 2400 mg, with GBP 1800 mg at 32% and GBP 2400 mg at 34%, both higher than PBO at 14%. Statistical significance is indicated by double and triple asterisks for P-values less than 0.01 and 0.001 respectively.*

FDA Label Image

Figure 4. Responder Rate In Patients Receiving Gabapentin Expressed As A Difference From Placebo By Dose And Study (01e45240 Figure 05)

A scatter plot illustrating percentage difference versus daily dose in milligrams across three studies labeled 'Study a,' 'Study b,' and 'Study c.' Daily doses on the x-axis range from 600 mg to 1800 mg, while the percentage difference on the y-axis ranges from 2% to 22%. Data points are marked with different symbols and accompanied by letters for each study category.*

FDA Label Image

01e45240-figure-06 (01e45240 Figure 06)

Label for Gabapentin Capsules USP, 300 mg strength, containing 30 capsules. The label includes the NDC 58517-060-30 and states the product is Rx-only. Distributed by New Horizon Rx Group, LLC, Kenner, LA. Storage instructions and manufacturing details by Aurobindo Pharma Limited, India, are also provided.*

* 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.