Gabapentin
Product Images NDC 50436-1263

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 50436-1263). 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)

A composite of three charts related to gabapentin studies. Figure 1 shows a line graph of weekly mean pain scores over 8 weeks comparing placebo and gabapentin 3600 mg/day. Figure 2 presents weekly mean pain scores over 7 weeks comparing placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day. Figure 3 is a bar chart illustrating the proportion of responders with ≥50% pain score reduction at study endpoints in controlled PHN studies comparing placebo and gabapentin doses (1800, 2400, 3600 mg).*

FDA Label Image

Fig4 (Fig4)

A scatter plot illustrating percentage difference on the y-axis versus daily dose in milligrams on the x-axis, displaying data points from three studies labeled a, b, and c. Study a is shown in black squares, Study b in gray squares, and Study c in white squares, comparing differences at various daily doses ranging approximately from 600 mg to 1800 mg.*

FDA Label Image

Table1 (Img1)

A dosage table for Gabapentin based on renal function, showing creatinine clearance, total daily dose range in mg/day, specific dose regimens (mg) for TID, BID, and QD schedules, and supplemental post-hemodialysis doses. The table includes notes on dose adjustments for impaired renal clearance and a formula for estimating creatinine clearance (CLCr).*

FDA Label Image

Label Image (Lbl504361263)

Gabapentin 100 mg capsules, 30 count, with labeling including the NDC 50436-1263-1. The label indicates the product is packaged by Unit Dose Services, LLC, Miami, FL. Warning and storage instructions are also included, along with spaces for manufacturing and lot details.*

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Structure (Struct)

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

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Table-2 (Tab2)

A data table titled 'Table 2 Risk by indication for antiepileptic drugs in the pooled analysis' comparing placebo patients and drug patients in terms of events per 1000 patients across three indications: Epilepsy, Psychiatric, and Other. It includes columns for relative risk and risk difference of additional drug patients with events per 1000 patients.*

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Tab3 (Tab3)

A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing percentages of adverse reactions between Gabapentin (N=336) and placebo (N=227) groups. Reactions are categorized by body system, including nervous, digestive, metabolic, respiratory, and special senses, showing frequency rates for symptoms such as dizziness, somnolence, peripheral edema, and others.*

FDA Label Image

Tab4 (Tab4)

A table titled 'Adverse Reactions in Pooled Placebo-Controlled Add-On Trials in Epilepsy Patients >12 years of age' comparing adverse reaction rates (%) between Gabapentin (N=543) and Placebo (N=378) groups. It lists reactions by system categories: Body as a Whole, Cardiovascular, Digestive System, Nervous System, Respiratory System, Skin and Appendages, Urogenital System, and Special Senses, with corresponding percentage incidence values for each group.*

FDA Label Image

Tab5 (Tab5)

Table displaying adverse reactions in a placebo-controlled add-on trial for pediatric epilepsy patients aged 3 to 12 years, comparing Gabapentin (N=119) versus placebo (N=128). It lists percentages of patients experiencing various symptoms in categories such as Body As A Whole, Digestive System, Nervous System, and Respiratory System.*

FDA Label Image

Table-6 (Tab6)

A data table titled "Controlled PHN Studies: Duration, Dosages, and Number of Patients" presenting study duration, gabapentin target doses (mg/day), and patient counts receiving gabapentin or placebo across two studies. It lists two studies with durations of 8 and 7 weeks, doses ranging from 1800 to 3600 mg/day, and total patients receiving gabapentin (336) and placebo (227).*

* 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.