Gabapentin Tablet, Film Coated
Product Images NDC 80425-0036

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 80425-0036). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Advanced Rx Of 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

Gabapentin 800mg Tab Qty 30 Ndc 80425 0036

Packaging label for Gabapentin 800 mg oral film-coated tablets, bottle of 30 tablets, labeled by Advanced Rx of Tennessee, LLC. The label includes lot number, expiration date, storage instructions, and a QR code. The product NDC is 80425-0036.*

FDA Label Image

Gabapentin 800mg Tab Qty 60 Ndc 80425 0036

Gabapentin 800 mg film-coated tablets by Advanced Rx of Tennessee, LLC. The label indicates a package of 60 tablets with NDC 80425-0036-02, storage instructions between 20° to 25°C, and the lot number 60GAS001223 expiring on 12/31/2023. It includes a warning about federal law restricting distribution.*

FDA Label Image

Image 1

Chemical structure of gabapentin shown as a bicyclic molecule with amino and carboxyl functional groups attached.*

FDA Label Image

Image 3

A line graph titled 'Figure 1. Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1' comparing mean pain scores over 8 weeks. The x-axis represents weeks from baseline to week 8, and the y-axis shows mean pain scores from 0 to 10. Two plots: one for placebo (open circles) showing relatively stable pain scores around 6, and one for Gabapentin 3600 mg/day (solid triangles) showing a decline in pain scores from about 6 to approximately 3.8. The graph also marks a 4-week dose titration period followed by a 4-week fixed dose period.*

FDA Label Image

Image 4

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2' showing mean pain scores on the y-axis (0 to 10) over weeks (Baseline to 7) on the x-axis. It compares placebo with Gabapentin 1800 mg/day and 2400 mg/day across a 3-week dose titration period and a 4-week fixed dose period, depicting changes in pain scores over time.*

FDA Label Image

Image 5

A bar graph titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies' showing results from two studies. The graph compares placebo (PBO) and gabapentin (GBP) at doses of 1800 mg, 2400 mg, and 3600 mg. Study 1 shows 12% responders for PBO and 29% for GBP 3600. Study 2 shows 14% responders for PBO, 32% for GBP 1800, and 34% for GBP 2400, with significance levels indicated.*

FDA Label Image

Image 6

A scatter plot showing responder rate differences from placebo by daily gabapentin dose in milligrams. Data points for three studies (Study a, Study b, and Study c) represent response differences (%) in patients aged 12 or older with partial seizures receiving adjunctive therapy.*

FDA Label Image

Image

An illustration showing the formula for calculating Creatinine Clearance (CLCr). The formula incorporates age (years), weight (kg), serum creatinine (mg/dL), and includes an adjustment factor of 0.85 for female patients.*

* 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.