Gabapentin
Product Images NDC 50436-7285

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 50436-7285). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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

Fig1-2-3 (Fig123)

Three charts illustrating results from controlled postherpetic neuralgia (PHN) studies of Gabapentin. The first two line graphs show weekly mean pain scores over baseline and several weeks for placebo and varying doses of Gabapentin (3600 mg/day in Study 1; 1800 mg/day and 2400 mg/day in Study 2). The third is a bar chart depicting the proportion of responders with at least a 50% reduction in pain score at study endpoint, comparing placebo and Gabapentin doses in Studies 1 and 2.*

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Fig4 (Fig4)

A chart presenting data points from three studies (labeled a, b, c) showing difference percentages on the vertical axis versus daily dose in mg on the horizontal axis, ranging from 600 to 1800 mg. The chart compares the difference percentages across varying daily doses for each study.*

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Table1 (Img1)

Table titled 'Gabapentin Dosage Based on Renal Function' displays recommended total daily dose ranges and specific dose regimens of gabapentin in mg based on renal function measured by creatinine clearance (mL/min). It includes dosing for different creatinine clearance categories, post-hemodialysis supplemental doses, and explanatory notes on dose adjustments and creatinine clearance calculation.*

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Label Image (Lbl504367285)

Label for Gabapentin 300 MG capsules, 30 count, with NDC 50436-7285-01. The label shows storage instructions, manufacturing and packaging details, and the labeler as Unit Dose Services LLC, Miami, FL. Some lot and date information is redacted.*

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Structure (Struct)

Chemical structure of gabapentin showing a cyclohexane ring with attached amino (CH2NH2) and acetic acid (CH2CO2H) groups.*

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Table-2 (Tab2)

A data table titled 'Table 2 Risk by indication for antiepileptic drugs in the pooled analysis.' It compares the risk incidence of events per 1000 patients between placebo patients and drug patients for epilepsy, psychiatric, and other indications, also showing the relative risk and risk difference for these categories.*

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Tab3 (Tab3)

Table presenting adverse reactions in pooled placebo-controlled trials for postherpetic neuralgia comparing Gabapentin (N=336) and placebo (N=227). Adverse reactions are categorized by body system, with percentages listed for each reaction in both groups, including body as a whole, digestive system, metabolic and nutritional disorders, nervous system, respiratory system, and special senses.*

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Tab4 (Tab4)

Table presenting adverse reactions in pooled placebo-controlled add-on trials for epilepsy patients over 12 years, comparing Gabapentin (N=543) and placebo (N=378). The table lists percentages of various side effects by body system, including fatigue, nervous system effects like somnolence and dizziness, and special senses such as diplopia and amblyopia.*

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Tab5 (Tab5)

Table showing adverse reactions in a placebo-controlled add-on trial of Gabapentin in pediatric epilepsy patients aged 3 to 12 years. The table compares percentages of various adverse reactions like viral infection, fever, nausea, somnolence, hostility, and respiratory issues between Gabapentin and placebo groups.*

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Table-6 (Tab6)

A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' presenting study duration, gabapentin target doses in mg/day, and counts of patients receiving gabapentin or placebo across two studies. Study durations are 8 weeks and 7 weeks, with target doses of 3600 mg/day for study 1 and 1800 or 2400 mg/day for study 2.*

* 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.