Gabapentin
Product Images NDC 53217-243

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 53217-243). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals 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

Image (Gabapentin Usp 800mg 1)

A dosage table for Gabapentin from Aidarex Pharmaceuticals LLC showing daily dose ranges and dose regimens based on renal function measured by creatinine clearance. It includes adjustments for patients with varying clearance levels and specifies post-hemodialysis supplemental doses. Abbreviations for dosing frequency—TID, BID, QD—are defined.*

FDA Label Image

Image (Gabapentin Usp 800mg 2)

A formula calculation for creatinine clearance (CLCr) using age in years, weight in kg, serum creatinine in mg/dL, and a multiplier of 0.85 for female patients. This text panel likely appears in clinical or pharmacokinetic information related to Gabapentin.*

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A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' showing the incidence of events per 1000 patients for placebo and drug groups across different indications: Epilepsy, Psychiatric, and Other. It includes columns for Placebo Patients, Drug Patients, Relative Risk, and Risk Difference comparing additional events between drug and placebo groups.*

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Image (Gabapentin Usp 800mg 4)

Chemical structure of Gabapentin, showing the cyclohexane ring bonded to amino (CH2NH2) and carboxyl (CH2CO2H) groups.*

FDA Label Image

Image (Gabapentin Usp 800mg 5)

A line graph showing mean pain scores over eight weeks comparing Placebo and Gabapentin 3600 mg/day. The x-axis represents weeks, including a 4-week dose titration and a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 10. Gabapentin demonstrates a decreasing pain score trend, while Placebo remains relatively stable.*

FDA Label Image

Image (Gabapentin Usp 800mg 6)

A line graph showing mean pain score over a 7-week period comparing placebo with Gabapentin at doses of 1800 mg/day and 2400 mg/day. The timeline includes a 3-week dose titration period followed by a 4-week fixed dose period. Gabapentin groups show a greater decrease in pain score compared to placebo over time.*

FDA Label Image

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A bar chart titled 'Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing placebo (PBO) and Gabapentin (GBP) at varying doses in two studies. Study 1 shows 12% for PBO and 29% for GBP 3600 mg; Study 2 shows 14% for PBO, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Significance markers indicate p values less than 0.01 and 0.001.*

FDA Label Image

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A scatter plot chart showing the percentage difference on the y-axis versus daily dose in mg on the x-axis (600, 900, 1200, 1800). It includes data points from three studies labeled as STUDY a, STUDY b, and STUDY c, each with distinct markers. The chart compares difference percentages at various daily doses.*

FDA Label Image

Image Description (Gabapentin Usp 800mg 9)

The packaging label for Gabapentin, USP 800mg tablets by Aidarex Pharmaceuticals LLC. The label indicates a bottle with 30 white oblong tablets, each scored on one side. It is labeled as generic for Neurontin with NDC 53217-0243-30. The manufacturer is Invagen Pharmaceuticals, Inc., Hauppauge, NY.*

* 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.