Gabapentin Tablet
Product Images NDC 85509-1166

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 85509-1166). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Phoenix Rx 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 (85509 1166)

Label for Gabapentin Tablets, USP 600 mg, oral tablet form. The label includes NDC 85509-1166-3, package size of 30 tablets, and prescription-only status. Manufactured by Ascent Pharmaceuticals, Inc and repackaged by Phoenix Rx LLC. Storage instructions and dispensing guidance for pharmacists are also present.*

FDA Label Image

Clcr (Equation)

A mathematical formula demonstrating creatinine clearance (CLCr) calculation using age, weight, gender adjustment, and serum creatinine levels, typically found in pharmacological or medical dosing information sections.*

FDA Label Image

Figure-1 (Figure1)

Line graph showing weekly mean pain scores over 8 weeks in a study population. The x-axis represents weeks from baseline to week 8, and the y-axis shows the mean pain score from 0 to 10. Two groups are compared: placebo and gabapentin 3600 mg/day, illustrating a decrease in pain scores over time for gabapentin relative to placebo.*

FDA Label Image

Figure-2 (Figure2)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2' showing mean pain scores from baseline through 7 weeks. The x-axis represents weeks, including a 3-week dose titration period and a 4-week fixed dose period. The y-axis represents mean pain scores from 0 to 10. Three lines depict placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day groups, illustrating pain score trends over time with Gabapentin groups showing a larger decrease compared to placebo.*

FDA Label Image

Figure-3 (Figure3)

A bar chart titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies.' It compares response rates in two studies between placebo (PBO) and different doses of gabapentin (GBP). Study 1 shows 12% response 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 with p-values less than 0.01 and 0.001 for certain comparisons.*

FDA Label Image

Figure-4 (Figure4)

A scatter plot chart titled 'Responder Rate in Patients Receiving Gabapentin Expressed as a Difference from Placebo by Dose and Study,' showing the difference in responder rate percentage on the y-axis and daily gabapentin dose in mg on the x-axis. Data points represent three studies (a, b, c) with doses of 600, 900, 1200, and 1800 mg, illustrating results for adjunctive therapy in patients aged 12 years and older with partial seizures.*

FDA Label Image

Struc (Struct)

Chemical structure of gabapentin showing a cyclohexane ring bonded to aminomethyl and acetic acid 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.