Gabapentin
Product Images NDC 71610-463

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 71610-463). 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 600 mg (71610 0463 30)

Bottle Label 600 mg (71610 0463 30)
Gabapentin USP 600 mg tablets packaging label showing the NDC 71610-0463-30. The label includes storage instructions, manufacturer information for SciGen Pharmaceuticals Inc, and that the product is repackaged by Aphena Pharma Solutions - Tennessee, LLC. The package contains 30 tablets and is marked RX only.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1 (Image 01)

Figure 1 (Image 01)
A line graph showing mean pain scores over an 8-week period comparing placebo and Gabapentin 3600 mg/day. The x-axis represents weeks, including a 4-week dose titration period followed by a 4-week fixed dose period. The y-axis measures mean pain score ranging from 0 to 10. Gabapentin shows a decrease in pain score 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 two doses of Gabapentin (1800 mg/day and 2400 mg/day). The timeline is divided into a 3-week dose titration period and a 4-week fixed dose period, showing a consistent decrease in pain scores for both Gabapentin groups compared to placebo.*
FDA Label Image

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' comparing proportions of responders between placebo (PBO) and Gabapentin (GBP) at different dosages across two studies. Study 1 shows 12% for placebo and 29% for GBP 3600. Study 2 shows 14% for placebo, 32% for GBP 1800, and 34% for GBP 2400. Statistical significance is indicated with p-values less than 0.01 and 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), which involves age, weight, serum creatinine levels, and a factor for female patients (0.85). The formula calculates CLCr using age in years, weight in kilograms, and serum creatinine in mg/dL.*
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 group (CH2NH2) and a carboxyl group (CH2CO2H). This diagram depicts the molecular arrangement of 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 percentage differences against daily doses in milligrams (mg) for Gabapentin across three studies labeled a, b, and c. The x-axis represents daily doses from 600 to 1800 mg, and the y-axis shows the percentage difference from 2% to 22%. Each study is represented by a different colored square marker as indicated by the legend on the right.*

* 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.