Gabapentin Capsule
Product Images NDC 71610-166

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 71610-166). 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 0166 60)

Bottle Label 400 mg (71610 0166 60)
Label for Gabapentin USP 400 mg capsules, containing 90 capsules. The label shows the product name, strength, dosage form, and quantity. It includes storage instructions and indicates repackaging by Aphena Pharma Solutions - Tennessee, LLC. The original manufacturer is Invagen Pharmaceuticals Inc., located in Hauppauge, NY. The label states the product is RX only.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1 (Gabapentin Capsules Fig01)

Figure 1 (Gabapentin Capsules Fig01)
A line graph depicting mean pain scores over eight weeks comparing placebo and gabapentin 3600 mg/day. The x-axis represents time in weeks, including a 4-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 10. Gabapentin shows a decreasing mean pain score trend, while placebo remains relatively stable.*
FDA Label Image

Figure 2 (Gabapentin Capsules Fig02)

Figure 2 (Gabapentin Capsules Fig02)
Line graph showing mean pain score over 7 weeks for treatment groups receiving placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day. The graph includes a 3-week dose titration period followed by a 4-week fixed dose period. Scores decrease more for gabapentin groups compared to placebo over time.*
FDA Label Image

Figure 3 (Gabapentin Capsules Fig03)

Figure 3 (Gabapentin Capsules Fig03)
A bar graph titled 'Proportion of Responders' showing the percentage of patients with at least 50% reduction in pain score at endpoint in controlled PHN studies. Two studies are compared: Study 1 displaying response rates of 12% for placebo and 29% for GBP 3600, and Study 2 with 14% for placebo, 32% for GBP 1800, and 34% for GBP 2400, with significance levels noted (p < 0.01, p < 0.001).*
FDA Label Image

Figure 4 (Gabapentin Capsules Fig04)

Figure 4 (Gabapentin Capsules Fig04)
A chart showing the percentage difference versus daily dose (mg) for gabapentin from three studies labeled Study a, Study b, and Study c. The x-axis represents daily dose in milligrams ranging approximately from 600 to 1800 mg. The y-axis represents the difference in percentage from about 2% to 22%. The data points are marked by different shaded squares corresponding to the three studies, with Study a in black, Study b in gradient gray, and Study c in white. Some points have letters a, b, and c next to them indicating grouping or comparison.*
FDA Label Image

Formula (Gabapentin Capsules Formula)

Formula (Gabapentin Capsules Formula)
A text panel showing the formula for estimating Creatinine Clearance (CLCr), which involves age in years, weight in kilograms, serum creatinine in mg/dL, and a coefficient adjustment of 0.85 for female patients.*
FDA Label Image

Structural Formula (Gabapentin Capsules Str)

Structural Formula (Gabapentin Capsules Str)
Chemical structure of gabapentin showing a cyclohexane ring bonded to a side chain containing amino and carboxyl functional groups.*

* 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.