Gabapentin
Product Images NDC 16590-492

6 FDA label images from Stat Rx Usa Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 16590-492). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Stat Rx Usa 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

Label Image (Gabapentin 400mg Label 492)

Label Image (Gabapentin 400mg Label 492)
Packaging label for GABAPENTIN 400 mg capsules, 30 count, by STAT RX USA LLC. The label states it is generic for Neurontin. It includes the NDC number 16590-492-30 and notes each capsule contains 400 mg of gabapentin. The manufacturer is Amneal Pharmaceuticals, Glasgow, KY. The label includes cautionary warnings and storage instructions, along with a barcode.*
FDA Label Image

Dc2d0eb8-figure-01 (Dc2d0eb8 Figure 01)

Dc2d0eb8-figure-01 (Dc2d0eb8 Figure 01)
Chemical structure of gabapentin, showing a cyclohexane ring attached to an amino group and a carboxymethyl side chain.*
FDA Label Image

Dc2d0eb8-figure-02 (Dc2d0eb8 Figure 02)

Dc2d0eb8-figure-02 (Dc2d0eb8 Figure 02)
A line graph depicting mean pain scores over an 8-week period comparing placebo and gabapentin 3600 mg/day. The x-axis represents weeks divided into a 4-week dose titration period and a 4-week fixed dose period, and the y-axis shows mean pain scores from 0 to 10. Gabapentin shows a decreasing trend in pain scores with statistically significant differences (p<0.01) compared to placebo, which remains relatively stable.*
FDA Label Image

Dc2d0eb8-figure-03 (Dc2d0eb8 Figure 03)

Dc2d0eb8-figure-03 (Dc2d0eb8 Figure 03)
A line graph comparing mean pain scores over 8 weeks between placebo and Gabapentin 3600 mg/day groups. The x-axis represents weeks, including a 4-week dose titration period and a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 10. Gabapentin shows a decreasing trend in pain scores, while placebo remains relatively stable.*
FDA Label Image

Dc2d0eb8-figure-04 (Dc2d0eb8 Figure 04)

Dc2d0eb8-figure-04 (Dc2d0eb8 Figure 04)
A bar chart comparing the percentage of responders at the endpoint across two studies. The chart displays results for placebo (PBO) and Gabapentin (GBP) at different dosages (3600 mg, 1800 mg, and 2400 mg). Percentages are shown above each bar, and statistical significance is indicated with p-values less than 0.01 and 0.001.*
FDA Label Image

Dc2d0eb8-figure-05 (Dc2d0eb8 Figure 05)

Dc2d0eb8-figure-05 (Dc2d0eb8 Figure 05)
A scatter plot chart showing the difference (%) on the y-axis versus daily dose (mg) on the x-axis for Gabapentin. The chart compares three studies labeled a, b, and c, represented by black, gray, and white squares respectively, with daily doses ranging from 600 mg to 1800 mg and difference percentages from about 7% to 18%.*

* 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.