Gabapentin
Product Images NDC 67296-1710

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 67296-1710). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Redpharm Drug, 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.

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Table titled 'Gabapentin Dosage Based on Renal Function' showing dosage ranges and dose regimens in mg for different renal function categories based on creatinine clearance (mL/min). The table includes rows for creatinine clearance levels ≥ 60, >30 to 59, >15 to 29, and 15, with corresponding total daily dose ranges and dose regimens divided into TID, BID, and QD frequencies. It also displays post-hemodialysis supplemental doses in mg. Additional footnotes explain dose adjustments for patients with reduced renal function and provide a formula to estimate creatinine clearance using age, weight, serum creatinine, and gender.*

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A data table titled "Risk by Indication for Antiepileptic Drugs in the Pooled Analysis" showing the incidence of adverse events for epilepsy, psychiatric, and other indications. It compares placebo and drug patients with events per 1,000 patients, relative risk, and risk difference of additional drug patients with events per 1,000 patients.*

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A data table titled 'TABLE 3. Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' showing percentages of various adverse reactions reported for Gabapentin (N=336) versus Placebo (N=227). The table categorizes reactions by body system including Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, with comparative percentage values for each adverse event.*

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A data table titled 'TABLE 4. Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epilepsy Patients >12 years of age' listing percentages of adverse reactions for Gabapentin (N=543) versus Placebo (N=378). Reactions are categorized by body system, including nervous system, digestive system, cardiovascular, respiratory, and others, with specific conditions such as fatigue, somnolence, dizziness, and diplopia recorded for both groups.*

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A data table titled 'TABLE 5. Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years.' It compares adverse reactions reported for Gabapentin (N=119) and placebo (N=128) across different body systems including body as a whole, digestive system, nervous system, and respiratory system. The table lists percentages of patients experiencing each reaction, such as viral infection, fever, nausea, somnolence, hostility, and bronchitis.*

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Chemical structure of gabapentin, showing a cyclohexane ring attached to an amino group (CH2NH2) and a carboxyl group (CH2CO2H).*

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Data table titled 'TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients' presenting study duration, gabapentin target dose in mg/day, and patient counts receiving gabapentin or placebo for two studies of 7 to 8 weeks duration with doses ranging from 1,800 to 3,600 mg/day.*

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A line graph depicting mean pain scores over an 8-week period comparing placebo and gabapentin 3600 mg/day. The x-axis represents weeks, labeled from baseline to week 8, divided into a 4-week dose titration period and a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 9. Gabapentin demonstrates a decreasing mean pain score trend, whereas placebo scores remain relatively stable.*

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A line graph showing mean pain scores over seven weeks for three groups: placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day. The x-axis represents the weeks with baseline through week 7, and the y-axis represents mean pain scores from 0 to 10. The chart includes a 3-week dose titration period followed by a 4-week fixed dose period.*

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A bar graph titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing placebo (PBO) and gabapentin (GBP) at different dosages in two separate studies. Study 1 shows 12% responders for placebo and 29% for GBP 3600 mg. Study 2 compares placebo (14%) with GBP 1800 mg (32%) and GBP 2400 mg (34%). Statistical significance is indicated with p-values less than 0.01 and 0.001.*

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A scatter plot showing percentage difference on the y-axis versus daily dose in milligrams on the x-axis. The graph includes data points for three studies labeled 'study a', 'study b', and 'study c', displayed at doses of 600, 900, 1200, and 1800 mg. Each study is represented by distinct symbols with corresponding percentage differences plotted.*

FDA Label Image

Label (Gabapentin 300 1710)

Label for GABAPENTIN 300 mg capsules, containing 60 capsules. The label includes the NDC 67296-1710-6 and indicates the product is Rx only. Manufactured by Invagen Pharmaceuticals Inc. in Hauppauge, NY, and distributed by RedPharm Drug, Eden Prairie, MN. The lot number is 901545X1 with an expiration date of 03/21.*

* 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.