Gabapentin Capsule
Product Images NDC 71610-631

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 71610-631). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Bottle Label 400 mg (71610 0631 53)

Gabapentin USP 400 mg capsules label showing a package size of 60 capsules. The label includes the NDC number 71610-0631-53, storage instructions, manufacturer information (SicGen Pharmaceuticals Inc, Hauppauge, NY), and repackager details (Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN). It also notes that the product is prescription only (Rx Only).*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1 (Image 01)

A line graph showing mean pain score over 8 weeks comparing placebo and Gabapentin 3600 mg/day. The x-axis represents weeks from baseline to 8, while the y-axis indicates mean pain score from 0 to 10. Two labeled periods are shown: a 4-week dose titration period followed by a 4-week fixed dose period. Gabapentin shows a decline in pain score compared to placebo which remains relatively stable.*

FDA Label Image

Figure 2 (Image 02)

A line graph showing mean pain scores over a 7-week period 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. The y-axis indicates mean pain scores from 0 to 10. Gabapentin groups show a decline in pain scores compared to placebo over time.*

FDA Label Image

Figure 3 (Image 03)

A bar graph titled 'Figure 3. Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies.' It compares placebo (PBO) and gabapentin (GBP) at various doses in two studies, showing higher responder rates for gabapentin 3600 mg in Study 1 and gabapentin 1800 mg and 2400 mg in Study 2 compared to placebo, with statistical significance indicated.*

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Cockcroft And Gault Equation (Image 04)

An illustration showing the formula to calculate creatinine clearance (CLCr) involving age, weight, serum creatinine, and a factor for female patients (0.85).*

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Gabapentin Structural Formula (Image 05)

Chemical structure of gabapentin, showing a cyclohexane ring attached to a central carbon with amino (CH2NH2) and carboxymethyl (CH2CO2H) substituents.*

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Image-09 (Image 09)

A scatter plot showing difference percentages by daily dose in milligrams for three studies labeled as a, b, and c. The x-axis represents daily doses ranging from 600 to 1800 mg, and the y-axis shows the percentage difference from about 7% to 22%. Each study is marked with distinct symbols: Study a with black squares, Study b with shaded squares, and Study c with white 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.