Gabapentin Capsule
Product Images NDC 71610-146

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 71610-146). 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 300 mg (71610 0146 30)

Bottle Label 300 mg (71610 0146 30)
Label for Gabapentin 300 mg oral capsules, containing 30 capsules per container. The label shows the proprietary and generic name Gabapentin, strength 300 mg, and manufacturer SciGen Pharmaceuticals Inc in Hauppauge, NY. The product is repackaged by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. It is for prescription use only (RX Only).*
FDA Label Image

Aphena Pharma Solutions (TN)

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 at 3600 mg/day. The x-axis shows weeks from baseline to week 8, and the y-axis shows mean pain scores from 0 to 10. Two study phases are noted: a 4-week dose titration period and a 4-week fixed dose period. Gabapentin shows a greater reduction in pain scores over time compared to placebo.*
FDA Label Image

Figure 2 (Image 02)

Figure 2 (Image 02)
Line graph showing mean pain scores over 7 weeks comparing placebo with Gabapentin at doses of 1800 mg/day and 2400 mg/day. The x-axis represents weeks including a 3-week dose titration period and a 4-week fixed dose period, while the y-axis shows the mean pain score values from 0 to 10. Gabapentin groups show a greater reduction in mean pain scores than placebo 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' displays results from two studies comparing placebo (PBO) and Gabapentin (GBP) at different doses. Study 1 shows 12% responders 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. Significance levels are indicated with asterisks (** p<0.01, *** p<0.001).*
FDA Label Image

Cockcroft And Gault Equation (Image 04)

Cockcroft And Gault Equation (Image 04)
An equation illustrating the calculation of creatinine clearance (CLCr) based on age, weight, serum creatinine levels, and adjusted for female patients by a 0.85 factor.*
FDA Label Image

Gabapentin Structural Formula (Image 05)

Gabapentin Structural Formula (Image 05)
Chemical structure of Gabapentin showing its molecular configuration with cyclohexane ring attached to amino and carboxyl functional groups.*
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 graph showing percentage difference versus daily dose in milligrams for Gabapentin. The graph compares three studies labeled a, b, and c, with daily doses at approximately 600, 900, 1200, and 1800 mg. Each study's data points are marked with distinct square shapes and letters.*

* 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.