Gabapentin
Product Images NDC 53002-1472

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 53002-1472). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rpk 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.

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A table titled 'Gabapentin Dosage Based on Renal Function' presenting dosage regimens according to creatinine clearance levels (≥60, >30 to 59, >15 to 29, 15 mL/min) and corresponding total daily dose ranges and dose regimens in mg. It includes a section on post-hemodialysis supplemental doses and notes on dosing adjustments and creatinine clearance estimation formula. Abbreviations TID, BID, and QD indicate dosing frequency.*

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A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' showing risk comparisons between placebo and drug patients for epilepsy, psychiatric, and other indications. It lists events per 1,000 patients in placebo and drug groups, relative risk, and risk difference for each indication and total.*

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A data table titled 'TABLE 3. 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 Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, listing specific conditions and their corresponding incidence percentages.*

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A table titled 'TABLE 4. Adverse Reactions in Pooled Placebo-Controlled Add-On Trials in Epilepsy Patients >12 years of age' comparing percentages of various adverse reactions between Gabapentin (N=543) and placebo (N=378). Reactions are grouped by body system, including fatigue, dizziness, somnolence, and others, with incidence rates listed for both Gabapentin and placebo groups.*

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A data table titled 'Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years,' showing the percentage of patients experiencing various adverse reactions. It compares Gabapentin (N=119) to Placebo (N=128) across categories such as Body As A Whole, Digestive System, Nervous System, and Respiratory System with specific adverse events and their respective percentages.*

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Chemical structure of gabapentin showing a cyclohexane ring attached to amino and carboxymethyl groups.*

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Table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' summarizing two studies of Gabapentin. It lists study number, duration (7-8 weeks), target gabapentin doses (1,800 to 3,600 mg/day), and patient counts receiving gabapentin or placebo, with totals of 336 and 227 patients respectively.*

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A line graph showing mean pain score over an 8-week period comparing placebo and Gabapentin 3600 mg/day. The x-axis represents weeks, divided into a 4-week dose titration period and a 4-week fixed dose period. The y-axis shows the mean pain score from 0 to 9. Gabapentin shows a decreasing pain score trend compared to placebo.*

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A line graph showing mean pain score over 7 weeks comparing placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day. The x-axis represents weeks including a 3-week dose titration period and a 4-week fixed dose period, while the y-axis shows mean pain scores decreasing over time 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 (PBO) and gabapentin (GBP) doses in two studies. Study 1 shows 12% response for placebo and 29% for GBP 3600 mg. Study 2 shows 14% for placebo, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance is indicated with p-values less than 0.01 and 0.001.*

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A scatter plot showing percentage difference on the y-axis and daily dose in mg on the x-axis. The graph compares data points for three studies labeled STUDY a, STUDY b, and STUDY c, with daily doses ranging from 600 mg to 1800 mg and percentage differences from 2% to 22%.*

FDA Label Image

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GABAPENTIN 300MG CAPSULES carton label by RPK Pharmaceuticals, Inc. The label indicates a package of 30 capsules with dosing instructions to take 1 capsule three times a day or as directed. The label includes lot, NDC codes, barcodes, and prescription status (Rx only).*

FDA Label Image

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GABAPENTIN 100MG capsules packaging label from RPK Pharmaceuticals, Inc., containing 30 capsules. The label includes dosing instructions to take one capsule three times a day or as directed, along with standard regulatory and identification information such as lot number, expiration date, and barcodes.*

* 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.