Gabapentin
Product Images NDC 71610-442

8 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 71610-442). 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

71610 0442 30

71610 0442 30
Label for Gabapentin USP 800 mg tablets, bottle of 30 tablets, labeled by Aphena Pharma Solutions - Tennessee, LLC. Includes storage instructions, NDC number 71610-0442-30, manufacturer and repackager information, and Rx only status.*
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Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1 (Image 01)

Figure 1 (Image 01)
A line graph comparing mean pain scores over 8 weeks between placebo and Gabapentin 3600 mg/day. The X-axis represents weeks from baseline to 8, and the Y-axis shows mean pain scores from 0 to 10. The graph includes a 4-week dose titration period followed by a 4-week fixed dose period, illustrating a decline in pain scores for Gabapentin over time compared to placebo.*
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Figure 2 (Image 02)

Figure 2 (Image 02)
A line graph depicting mean pain scores over a 7-week period comparing placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day. The x-axis represents time in weeks, with a 3-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores ranging from 0 to 10.*
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Figure 3 (Image 03)

Figure 3 (Image 03)
A bar chart titled 'Figure 3. Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint: Controlled PHN Studies' showing the percentage of responders in two studies. Study 1 compares placebo (12%) and Gabapentin 3600 mg (29%), while Study 2 compares placebo (14%) with Gabapentin 1800 mg (32%) and 2400 mg (34%). Statistical significance is indicated with p-values below 0.01 and 0.001.*
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Cockcroft And Gault Equation (Image 04)

Cockcroft And Gault Equation (Image 04)
An illustration showing a medical formula used to calculate creatinine clearance (CLCr). The formula incorporates age, weight, serum creatinine levels, and a factor for female patients, relevant for dosing or kidney function assessment.*
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Gabapentin Structural Formula (Image 05)

Gabapentin Structural Formula (Image 05)
Chemical structure of gabapentin showing a cyclohexane ring attached to a carbon bearing an amino (CH2NH2) group and a carboxyl (CH2CO2H) group.*
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Figure 4. Responder Rate In Patients Receiving Gabapentin Expressed As A Difference From Placebo By Dose And Study: Adjunctive Therapy Studies In Patients ≥12 Years Of Age With Partial Seizures (Image 09)

Figure 4. Responder Rate In Patients Receiving Gabapentin Expressed As A Difference From Placebo By Dose And Study: Adjunctive Therapy Studies In Patients ≥12 Years Of Age With Partial Seizures (Image 09)
A scatter plot chart showing the percentage difference versus daily dose in milligrams (600, 900, 1200, 1800 mg). The chart compares data points from three studies labeled as Study a, Study b, and Study c, indicated by different colored squares. The y-axis is labeled 'difference (%)' ranging from 2% to 22%, and the x-axis is labeled 'daily dose (mg)'.*

* 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.