Gabapentin Capsule
Product Images NDC 71610-198

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 71610-198). 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 0198 53

71610 0198 53
Gabapentin 400 mg capsules label showing the NDC 71610-0198-53. It includes storage instructions between 20-25 degrees Celsius and advises dispensing in a tight, light-resistant container. The label indicates the manufacturer as SciGen Pharmaceuticals Inc and the packager as Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. The label is marked RX Only and displays lot number and expiration date information.*
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 an 8-week period for 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, with Gabapentin scores declining more significantly than Placebo scores over time.*
FDA Label Image

Figure 2 (Image 02)

Figure 2 (Image 02)
A line graph showing mean pain scores over 7 weeks comparing placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day. The graph includes two periods: a 3-week dose titration and a 4-week fixed dose period, demonstrating pain score trends across the study duration.*
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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 placebo (PBO) to Gabapentin (GBP) dosages in two studies. Study 1 shows 12% responders for placebo and 29% for GBP 3600 mg. Study 2 shows 14% for placebo and 32% and 34% for GBP 1800 mg and 2400 mg, respectively. Statistical significance is indicated with p-values less than 0.01 and 0.001.*
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Cockcroft And Gault Equation (Image 04)

Cockcroft And Gault Equation (Image 04)
A data table showing the formula for calculating creatinine clearance (CLCr) based on age, weight, serum creatinine, and a factor for female patients. The formula is presented as an equation with variables for age (years), weight (kg), and serum creatinine (mg/dL).*
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Gabapentin Structural Formula (Image 05)

Gabapentin Structural Formula (Image 05)
Chemical structure of Gabapentin showing a cyclohexane ring attached to a side chain with an amine group (CH2NH2) and a carboxylic acid group (CH2CO2H).*
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)
Scatter plot chart depicting percentage difference on the y-axis versus daily gabapentin dose in milligrams on the x-axis, showing data points from three studies labeled a, b, and c. The doses range from about 600 mg to 1800 mg, with corresponding differences from approximately 7% to 18%, illustrating comparative study results.*

* 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.