Gabapentin
Product Images NDC 67046-227

11 FDA label images from Contract Pharmacy Services-pa · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 67046-227). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Contract Pharmacy Services-pa, 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

Structural Formula For Gabapentin (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 01)

Structural Formula For Gabapentin (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 01)
Chemical structure of gabapentin, showing a cyclohexane ring with two attached groups: an aminomethyl group (CH2NH2) and an acetic acid group (CH2CO2H). This molecular diagram illustrates the arrangement of these functional groups around the ring.*
FDA Label Image

Figure 1 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 02)

Figure 1 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 02)
A line graph showing mean pain scores over 8 weeks comparing Gabapentin 3600 mg/day to placebo. The graph includes a 4-week dose titration period followed by a 4-week fixed dose period. Gabapentin shows a marked decrease in mean pain score compared to placebo, with statistically significant differences (p < 0.01) indicated at multiple time points.*
FDA Label Image

Figure 2 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 03)

Figure 2 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 03)
A line graph showing mean pain scores over seven weeks for placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day groups. The horizontal axis represents weeks, starting from baseline, including a 3-week dose titration period and a 4-week fixed dose period. The vertical axis shows mean pain scores from 0 to 10. Both Gabapentin groups show a greater decrease in pain scores compared to placebo, with significant differences marked (p < 0.01).*
FDA Label Image

Figure 3 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 04)

Figure 3 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 04)
A bar chart comparing the percentage of responders at endpoint between placebo (PBO) and Gabapentin (GBP) at doses of 3600, 1800, and 2400 mg across two studies. 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, with statistical significance indicated for the GBP groups.*
FDA Label Image

Figure 4 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 05)

Figure 4 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 05)
A chart showing percentage difference by daily dose (mg) for Gabapentin across three studies labeled as study a, study b, and study c. The x-axis represents daily dose in milligrams (600 to 1800 mg), and the y-axis shows difference in percentage ranging from 2% to 22%. Data points for each study are plotted, indicating variability in percentages at different doses.*
FDA Label Image

Table 2 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 06)

Table 2 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 06)
A data table comparing the incidence percentages of adverse effects in clinical trial subjects receiving Gabapentin tablets (N=336) versus placebo (N=227). The table categorizes side effects by body system, such as Nervous System, Digestive System, Metabolic and Nutritional Disorders, Respiratory System, and others, listing specific symptoms like dizziness, somnolence, peripheral edema, and rash, with corresponding percentages for each treatment group.*
FDA Label Image

Table 3 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 07)

Table 3 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 07)
A data table comparing the percentages of adverse events reported in subjects taking Gabapentin tablets versus placebo. It categorizes adverse events by body system, including fatigue, cardiovascular, digestive, nervous, respiratory, and urogenital systems, highlighting differences in incidence rates between Gabapentin and placebo groups.*
FDA Label Image

Table 4 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 08)

Table 4 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 08)
A data table comparing the percentage of adverse events by body system between Gabapentin tablets (N=119) and placebo (N=128). The table lists adverse events such as viral infection, fever, weight increase, fatigue, nausea, somnolence, hostility, emotional lability, dizziness, hyperkinesia, bronchitis, and respiratory infection, with corresponding percentages for each group.*
FDA Label Image

Table 5 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 09)

Table 5 (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 09)
A data table detailing Gabapentin dosage adjustments based on renal function, specified by creatinine clearance rates in mL/min. It includes total daily dose ranges (mg/day), specific dose regimens by mg and frequency (TID or QD), and post-hemodialysis supplemental doses in mg. Footnotes clarify dose reductions for patients with low creatinine clearance and maintenance doses for hemodialysis patients.*
FDA Label Image

Glenmark Logo (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 10)

FDA Label Image

Blister Of 30 Tablets (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 11)

Blister Of 30 Tablets (33b9c9ba F71c 49f9 9bfc F0d8a68aeab6 11)
Gabapentin 800 mg tablet packaging label from Contract Pharmacy Services-PA, showing a 30-count blister card with numbered dose compartments. The label includes storage instructions, lot number, expiration date 09/10, and contact information for the pharmacy located in Warrington, PA.*

* 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.