Gabapentin
Product Images NDC 42254-109

13 FDA label images from Rebel Distributors Corp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 42254-109). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rebel Distributors Corp, 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

Structural Formula For Gabapentin (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 01)

Structural Formula For Gabapentin (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 01)
Chemical structure diagram of the active ingredient gabapentin, showing its cyclohexane ring with amino and carboxyl functional groups.*
FDA Label Image

Figure 1 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 02)

Figure 1 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 02)
A line graph showing mean pain score over 8 weeks comparing placebo and Gabapentin 3600 mg/day. The x-axis represents weeks from baseline to week 8, and the y-axis represents mean pain score from 0 to 10. Gabapentin shows a consistent decrease in mean pain score during a 4-week dose titration and 4-week fixed dose period compared to placebo.*
FDA Label Image

Figure 2 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 03)

Figure 2 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 03)
A line graph showing mean pain score over 7 weeks comparing placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day. The graph distinguishes a 3-week dose titration period followed by a 4-week fixed dose period, with Gabapentin groups showing a greater reduction in pain scores than placebo.*
FDA Label Image

Figure 3 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 04)

Figure 3 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 04)
A bar chart comparing the percentage of responders at endpoint between placebo (PBO) and gabapentin (GBP) at doses of 1800, 2400, and 3600 mg across two studies. Study 1 shows 12% for PBO and 29% for GBP 3600 mg; Study 2 shows 14% for PBO, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance is indicated for differences between groups.*
FDA Label Image

Figure 4 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 05)

Figure 4 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 05)
A scatter plot showing the relationship between daily dose in mg (600 to 1800) on the x-axis and difference percentage (2 to 22%) on the y-axis. Three studies labeled a, b, and c are plotted with different markers and positioned to indicate varying percentage differences at specific doses.*
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Table 2 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 06)

Table 2 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 06)
A data table comparing the percentage of various adverse effects reported in participants taking Gabapentin tablets (N=336) versus a placebo group (N=227). The effects are categorized by body system, including nervous, digestive, respiratory, and metabolic disorders, with percentages listed for each symptom such as dizziness, somnolence, peripheral edema, and rash.*
FDA Label Image

Table 3 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 07)

Table 3 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 07)
A data table comparing the percentage incidence of adverse events by body system for Gabapentin tablets (N=543) and Placebo (N=378). It details specific side effects such as fatigue, dizziness, somnolence, ataxia, and others, showing higher rates generally for Gabapentin across multiple systems including nervous, digestive, and respiratory systems.*
FDA Label Image

Table 4 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 08)

Table 4 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 08)
A data table comparing adverse events by body system for Gabapentin tablets versus placebo. It includes event types such as viral infection, fever, nausea, somnolence, hostility, and respiratory infections, with percentage values indicated for both Gabapentin (N=119) and placebo (N=128) groups.*
FDA Label Image

Table 5 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 09)

Table 5 (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 09)
A table presenting dosing guidelines for Gabapentin based on renal function measured by creatinine clearance (mL/min). It outlines total daily dose ranges (mg/day) and specific dose regimens (mg) by dosing frequency (TID or QD), including post-hemodialysis supplemental doses for patients with different creatinine clearance levels.*
FDA Label Image

Glenmark Logo (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 10)

FDA Label Image

Glenmark Logo (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 11)

FDA Label Image

Gabapentin 600mg (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 12)

Gabapentin 600mg (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 12)
Gabapentin 600 mg tablets label by Rebel Distributors Corp under the Physician Partner brand. The label indicates #90 tablets, each containing 600 mg of Gabapentin USP. Tablets are described as white to off-white, film-coated, oval shaped, biconvex scored with "G" and "31" debossed on one side. Manufactured by Glenmark Generics Ltd, India. Packaging instructions include storage at controlled room temperature (15-30°C) and warnings to keep out of reach of children.*
FDA Label Image

Gabapentin 800mg (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 13)

Gabapentin 800mg (F8c7c414 Fcd2 47dd 8226 8d0c35d3e9f0 13)
Gabapentin 800mg tablets packaging label from Physician Partner, a division of Rebel Distributors Corp. The label states a quantity of 90 tablets, each containing 800mg of Gabapentin USP. It includes the product ID QG010990 and manufacturer information, Glenmark Generics Ltd., Goa, India. The label features storage instructions and cautions on a red background at the bottom.*

* 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.