Gabapentin Capsule
Product Images NDC 71610-421

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 71610-421). 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

Cockcroft And Gault Equation (Image 04)

Cockcroft And Gault Equation (Image 04)
An illustration depicting a formula to calculate creatinine clearance (CLCr) based on age, weight, serum creatinine, and a factor for female patients. The formula includes multiplication and division elements with variables for 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 its cyclohexane ring attached to an aminomethyl and a carboxymethyl group.*
FDA Label Image

Figure 1 (Image 01)

Figure 1 (Image 01)
A line graph depicting mean pain scores over an 8-week period comparing placebo and Gabapentin 3600 mg/day groups. The x-axis represents weeks, including a 4-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores ranging from 0 to 10, illustrating a decline in pain scores for Gabapentin compared to placebo.*
FDA Label Image

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 shows weeks, divided into a 3-week dose titration period and a 4-week fixed dose period. The y-axis represents mean pain scores from 0 to 10. Pain scores decrease over time for both Gabapentin doses compared to placebo.*
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) at different dosages in two studies. The y-axis shows percentage responders from 0% to 100%. Study 1 shows 12% for placebo and 29% for GBP 3600 mg. Study 2 shows 14% for placebo, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance is indicated with p-values below 0.01 and 0.001.*
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 three studies (STUDY a, STUDY b, STUDY c) showing percentage difference versus daily dose in mg for Gabapentin. The doses range from 600 mg to 1800 mg, with percentage differences plotted between 7% and 20%. Each study is represented by differently colored square markers.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Bottle Label 100 mg (71610 0421 60)

Bottle Label 100 mg (71610 0421 60)
Label for Gabapentin USP 100 mg capsules, containing 90 capsules, manufactured by SciGen Pharmaceuticals Inc. and labeled by Aphena Pharma Solutions - Tennessee, LLC. The label includes storage instructions to store between 20-25 degrees Celsius and contains warnings to keep the drug out of reach of children.*

* 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.