Gabapentin Capsule
Product Images NDC 71610-211

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 71610-211). 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 0211 60

71610 0211 60
Gabapentin USP 300 mg capsule bottle label with a quantity of 90 capsules. The label includes storage instructions between 20-25 degrees Celsius, dispensing in a tight light-resistant container, and keeping out of reach of children. Labeler is Aphena Pharma Solutions - Tennessee, LLC, and the product NDC is 71610-0211-60.*
FDA Label Image

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 shows weeks, and the y-axis shows mean pain scores from 0 to 10. The graph indicates a 4-week dose titration period followed by a 4-week fixed dose period, with Gabapentin scores declining over time while placebo remains relatively constant.*
FDA Label Image

Figure 2 (Image 02)

Figure 2 (Image 02)
A line graph depicting mean pain scores over 7 weeks comparing placebo and gabapentin at 1800 mg/day and 2400 mg/day doses. The x-axis represents weeks, including a 3-week dose titration period and a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 10, with all groups showing decreases over time.*
FDA Label Image

Figure 3 (Image 03)

Figure 3 (Image 03)
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) doses across two studies. It shows responder percentages with significant increases in gabapentin groups (GBP 3600 mg, GBP 1800 mg, GBP 2400 mg) compared to placebo, with significance levels indicated (p < 0.01, p < 0.001).*
FDA Label Image

Cockcroft And Gault Equation (Image 04)

Cockcroft And Gault Equation (Image 04)
An illustration showing the formula for calculating creatinine clearance (CLCr), involving age, weight, serum creatinine, and a factor of 0.85 for female patients.*
FDA Label Image

Gabapentin Structural Formula (Image 05)

Gabapentin Structural Formula (Image 05)
Chemical structure of Gabapentin, showing a cyclohexane ring attached to an amino-methyl group and a carboxymethyl group, corresponding to the active ingredient Gabapentin.*
FDA Label Image

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 comparing differences in percentage against daily dose (mg) for three studies labeled Study a, Study b, and Study c. The x-axis represents daily dose ranging from 600 mg to 1800 mg, and the y-axis represents difference percentage from about 7% to 22%. Each study is represented by distinct square markers in black, gray, and white.*

* 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.