Gabapentin Tablet
Product Images NDC 55289-959

7 FDA label images from Pd-rx Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 55289-959). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pd-rx Pharmaceuticals, Inc., 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

55289959 Label (55289959)

55289959 Label (55289959)
Label for Gabapentin USP 600 mg tablets by PD-Rx Pharmaceuticals, Inc. The label shows the product NDC 55289-959-90 and states a package size of 90 tablets. It includes storage and dosage warnings, medication instructions in English and Spanish, and manufacturing information including lot number E20D92 and expiration date 11/2021.*
FDA Label Image

Figure1

Figure1
Line graph depicting mean pain scores over an 8-week period comparing placebo and Gabapentin at 3600 mg/day. The x-axis represents weeks, including a 4-week dose titration period followed by a 4-week fixed dose period. The y-axis shows the mean pain score, with scores decreasing over time for Gabapentin and remaining relatively stable for placebo.*
FDA Label Image

Figure2

Figure2
A line graph showing mean pain scores over seven weeks for placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day groups. The x-axis represents weeks starting at baseline, and the y-axis shows mean pain scores from 0 to 10. The graph notes a 3-week dose titration period followed by a 4-week fixed dose period, with gabapentin groups showing lower mean pain scores compared to placebo over time.*
FDA Label Image

Figure3

Figure3
A bar chart titled 'Proportion of Responders (patients with > 50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing placebo (PBO) with Gabapentin (GBP) at different doses in two studies. Study 1 shows 12% response for placebo and 29% for GBP 3600 mg. Study 2 shows 14% response for placebo, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance levels are noted with asterisks.*
FDA Label Image

Figure4

Figure4
A scatter plot chart comparing percent difference by daily dose of Gabapentin (mg) across three studies labeled as STUDY a, STUDY b, and STUDY c. The x-axis represents daily dose in mg from 600 to 1800, and the y-axis represents difference percentage from 2 to 22%. Data points show variance in difference percentage by dose for each study represented with distinct symbols.*
FDA Label Image

Structure.jpg (Structure)

Structure.jpg (Structure)
Chemical structure diagram of the active ingredient Gabapentin, showing its molecular arrangement including an amino group (H2N), carboxyl group (COOH), and a cyclohexane ring.*
FDA Label Image

Equation.jpg (Equation)

Equation.jpg (Equation)
A text panel showing a formula to calculate creatinine clearance (CLCr), which involves age, weight, serum creatinine, and an adjustment factor for female patients (0.85). It provides a calculation method relevant in clinical pharmacology.*

* 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.