Gabapentin Capsule
Product Images NDC 71610-126

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 71610-126). 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 100 mg (71610 0126 60)

Bottle Label 100 mg (71610 0126 60)
Label for Gabapentin 100 mg capsules, containing 90 capsules. The label specifies storage temperature, packaging details, and indicates the product is repackaged by Aphena Pharma Solutions - Tennessee, LLC. The original manufacturer is Aurobindo Pharma Limited, Hyderabad, India. It is marked for prescription use only.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Formula (Gabapentin Fig1)

Formula (Gabapentin Fig1)
A formula displaying the calculation for Creatinine Clearance (CLCr) based on age, weight, gender, and serum creatinine levels. The formula includes adjustments for female patients with a multiplication factor of 0.85.*
FDA Label Image

Figure 1 (Gabapentin Fig2)

Figure 1 (Gabapentin Fig2)
A line graph depicting mean pain scores over an 8-week period comparing placebo and gabapentin (3600 mg/day). The x-axis shows weeks from baseline to week 8, with a 4-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 9. Gabapentin scores decrease steadily over time, while placebo scores remain relatively constant.*
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Figure 2 (Gabapentin Fig3)

Figure 2 (Gabapentin Fig3)
A line graph showing mean pain scores over 7 weeks for three groups: placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day. The x-axis represents weeks from baseline to week 7, and the y-axis represents mean pain score from 0 to 10. The graph includes a 3-week dose titration period followed by a 4-week fixed dose period.*
FDA Label Image

Figure 3 (Gabapentin Fig4)

Figure 3 (Gabapentin Fig4)
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) dosages across two studies. It shows response percentages for Study 1 with PBO at 12% and GBP 3600 mg at 29%, and Study 2 with PBO at 14%, GBP 1800 mg at 32%, and GBP 2400 mg at 34%.*
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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 (Gabapentin Fig5)

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 (Gabapentin Fig5)
A scatter plot comparing percentage differences by daily dose (mg) for Gabapentin across three studies labeled a, b, and c. The x-axis shows daily doses from 600 to 1800 mg. The y-axis shows percentage difference from 2% to 22%. Data points for each study are distinguished by filled and unfilled squares with corresponding labels.*
FDA Label Image

Chemical Structure (Gabapentin Str)

Chemical Structure (Gabapentin Str)
Chemical structure of gabapentin, showing a cyclohexane ring bonded to amino and carboxyl 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.