Gabapentin Capsule
Product Images NDC 73352-231

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 73352-231). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Trifluent Pharma, 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

Image-12 (Image 12)

Table showing risk by indication for antiepileptic drugs in a pooled analysis. It compares events per 1,000 patients between placebo and drug patients across epilepsy, psychiatric, and other indications, including relative risk and risk difference of events in drug patients versus placebo patients.*

FDA Label Image

Image-14 (Image 14)

A table labeled 'TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing two studies with durations of 8 weeks and 7 weeks. It lists target gabapentin doses in mg/day (3000 for study 1 and 1800, 2400 for study 2) and the number of patients receiving gabapentin in each study (113 and 223, respectively), along with patients receiving gabapentin in another column (116 and 111). The table also shows totals for patients in both columns.*

FDA Label Image

Image-01 (Image 01)

A line graph comparing the mean pain score over 8 weeks for placebo and Gabapentin 3600 mg/day groups. The x-axis represents time in weeks with a 4-week dose titration period followed by a 4-week fixed dose period. The y-axis shows the mean pain score from 0 to 10. The graph shows a greater reduction in pain score over time for the Gabapentin group compared to the placebo group.*

FDA Label Image

Image-02 (Image 02)

A line graph showing mean pain score over 7 weeks comparing placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day. The X-axis represents weeks from baseline through week 7, and the Y-axis represents mean pain score from 0 to 10. The graph includes a 3-week dose titration period followed by a 4-week fixed dose period.*

FDA Label Image

Image-03 (Image 03)

A bar chart titled 'Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing percentages of responders in two studies. Study 1 shows 12% for placebo (PBO) and 29% for Gabapentin (GBP) 3600 mg. Study 2 shows 14% for placebo (PBO), 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance is indicated with asterisks for GBP groups compared to placebo.*

FDA Label Image

Gabapentin Structural Formula (Image 05)

Chemical structure of Gabapentin showing its molecular arrangement with a cyclohexane ring attached to amino and carboxyl functional groups.*

FDA Label Image

Image-09 (Image 09)

A scatter plot chart showing the percentage difference on the y-axis versus daily dose in mg on the x-axis, comparing three studies labeled as Study a, Study b, and Study c. The chart displays data points for doses 600, 900, 1200, and 1800 mg with percentage differences ranging approximately from 7% to 18%.*

FDA Label Image

Image-10 (Image 10)

A table titled 'Gabapentin Capsule Dosage Based on Renal Function' showing dosage adjustments of gabapentin capsules according to renal function (creatinine clearance in mL/min) and corresponding total daily dose ranges and dose regimens in mg. It also includes a row for post-hemodialysis supplemental doses with various mg values.*

FDA Label Image

Image-11 (Image 11)

A formula for calculating creatinine clearance (CLCr). It shows the equation involving age, weight, serum creatinine, and an adjustment factor for female patients.*

FDA Label Image

Label (Label)

Label for Gabapentin Capsules, USP 200 mg by Trifluent Pharma, LLC. The label indicates the product is prescription-only, with a package count of 100 capsules. It includes storage instructions, a reminder to provide a Medication Guide, and manufacturer information stating it is made in the USA by Trifluent Pharma in San Antonio, TX.*

* 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.