Gabapentin
Product Images NDC 68071-1212

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 68071-1212). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare Pharmaceuticals, 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

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Label for Gabapentin 300 mg capsules from NuCare Pharmaceuticals, Inc. The label indicates a package count of 60 capsules. Each capsule contains 300 mg of Gabapentin, USP. The capsules are described as oblong yellow opaque and are marked with '300mg' and 'IG322'. The label includes storage instructions and a warning to keep out of reach of children.*

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A table titled 'Gabapentin Dosage Based on Renal Function' showing dosage ranges and regimens based on renal function measured by creatinine clearance (mL/min). It includes daily dose ranges (mg/day) and dose regimens (mg) for different clearance levels, plus post-hemodialysis supplemental doses. The table defines abbreviations TID (three times a day), BID (two times a day), and QD (single daily dose), with footnotes explaining dose adjustments for low creatinine clearance and hemodialysis patients.*

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A text panel displaying the formula for calculating creatinine clearance (CLCr). The equation accounts for age, weight, serum creatinine levels, and includes a multiplier of 0.85 for female patients.*

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A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' showing risks of events per 1000 patients for placebo and drug patients across different indications: Epilepsy, Psychiatric, Other, and Total. Columns include incidence rates for placebo and drug patients, relative risk, and risk difference in additional drug patients per 1000.*

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A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing the incidence percentages of various adverse reactions for Gabapentin (N=336) and Placebo (N=227). Reactions are categorized by body system, including Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, with comparative percentages listed for each reaction.*

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Table showing adverse reactions in pooled placebo-controlled add-on trials in epilepsy patients over 12 years of age comparing Gabapentin (N=543) and Placebo (N=378). It lists reaction percentages by system categories including body as a whole, cardiovascular, digestive, nervous, respiratory, skin, urogenital, and special senses.*

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Table 5 presents adverse reactions in a placebo-controlled add-on trial for pediatric epilepsy patients aged 3 to 12 years, comparing Gabapentin (N=119) and placebo (N=128). It lists reactions by body system, including rates of viral infection, fever, weight increase, fatigue, digestive issues, nervous system symptoms, and respiratory conditions, with corresponding percentages for each group.*

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Chemical structure diagram of gabapentin, showing its molecular framework including the cyclohexane ring and attached functional groups (amine and carboxylic acid).*

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A data table titled 'TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing two studies with durations of 8 and 7 weeks, gabapentin target doses of 3600 mg/day and 1800 or 2400 mg/day given in three divided doses (TID), and the numbers of patients receiving gabapentin (113, 223) and placebo (116, 111), with totals provided.*

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A line graph comparing mean pain scores over an 8-week period between Placebo and Gabapentin at 3600 mg/day. The x-axis represents weeks, including a 4-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores. Gabapentin shows a consistent decrease in pain scores, while the placebo remains relatively stable.*

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A line graph depicting mean pain scores over 7 weeks for three groups: placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day. The x-axis represents weeks from baseline to week 7, including a 3-week dose titration period and a 4-week fixed dose period. The y-axis shows mean pain score from 0 to 10, highlighting decreasing pain scores for both Gabapentin doses compared to placebo.*

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A bar graph titled 'Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing placebo and gabapentin at different doses in two studies. The vertical axis shows percentage responders up to 100%. Study 1 compares placebo (12%) to gabapentin 3600 mg (29%). Study 2 compares placebo (14%) to gabapentin 1800 mg (32%) and 2400 mg (34%). Statistical significance is noted with p-values less than 0.01 and 0.001.*

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A chart depicting the percent difference on the y-axis versus daily dose in milligrams on the x-axis. It compares three studies labeled a, b, and c, showing data points at 600, 900, 1200, and 1800 mg daily doses. Study a's data points are represented by filled black squares, Study b by filled grey squares, and Study c by open squares.*

* 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.