Gabapentin Capsule
Product Images NDC 63187-392

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 63187-392). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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 recommendations according to renal function creatinine clearance (ml/min). It lists total daily dose ranges (mg/day) and dose regimens (mg) for different creatinine clearance levels, along with post-hemodialysis supplemental doses (mg). Footnotes explain dosage adjustments for patients with low creatinine clearance and those undergoing hemodialysis.*

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An illustration depicting the formula for calculating creatinine clearance (CLCr). The formula incorporates variables for age (years), weight (kg), serum creatinine (mg/dL), and includes a multiplication factor of 0.85 specifically for female patients.*

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A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' showing comparative risk metrics including incidence of events per 1000 patients for placebo versus drug patients, relative risk, and risk difference for epilepsy, psychiatric, other indications, and totals.*

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Table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' showing percentage incidence of various adverse reactions in subjects treated with Gabapentin (N=336) and Placebo (N=227). Reactions listed include categories: Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, with corresponding percentages for each reaction including asthenia, infection, diarrhea, dizziness, somnolence, and others.*

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A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epilepsy Patients >12 years of age' compares the percentage of patients experiencing various adverse reactions between Gabapentin (N=543) and placebo (N=378) groups. Reactions are categorized by body system, including nervous, digestive, cardiovascular, respiratory, and others, listing specific symptoms such as somnolence, dizziness, fatigue, and diplopia with their respective percentages.*

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A table presenting adverse reactions from a placebo-controlled add-on trial of gabapentin in pediatric epilepsy patients aged 3 to 12 years. It compares the percentage incidence of various adverse reactions between gabapentin (N=119) and placebo (N=128) groups, categorized by body system such as Body As A Whole, Digestive System, Nervous System, and Respiratory System.*

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Chemical structure of gabapentin, showing its molecular configuration with a cyclohexane ring attached to an amino group and a carboxyl group.*

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A data table titled 'TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients' presenting two studies including study duration, gabapentin target doses in mg/day, and the number of patients receiving gabapentin or placebo. The table summarizes data from studies lasting 7 to 8 weeks with gabapentin doses ranging from 1800 to 3600 mg/day and corresponding patient counts.*

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A line graph showing mean pain scores over an 8-week period comparing placebo and Gabapentin at 3600 mg/day. The graph includes a 4-week dose titration period followed by a 4-week fixed dose period, with pain scores decreasing notably for Gabapentin while remaining relatively stable for placebo.*

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A line graph depicting mean pain scores over a 7-week period, comparing placebo and two doses of gabapentin (1800 mg/day and 2400 mg/day). The x-axis represents weeks from baseline to week 7, and the y-axis shows mean pain score values 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 chart titled 'Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint: Controlled PHN Studies' presenting the percentage of responders in two studies comparing placebo (PBO) to different dosages of gabapentin (GBP). Study 1 shows 12% responders for PBO and 29% for GBP 3600. Study 2 shows 14% responders for PBO, 32% for GBP 1800, and 34% for GBP 2400, with significance levels indicated (p < 0.01, p < 0.001).*

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A scatter plot comparing percentage differences across three studies (a, b, c) at varying daily doses of gabapentin (600 mg, 900 mg, 1200 mg, 1800 mg). The vertical axis indicates difference percentage, and the horizontal axis indicates daily dose in mg.*

FDA Label Image

63187-392-90 (D3fd11fe 4d3f 4002 8f9e 42cc12b4252d 13)

Label for Gabapentin 100 mg capsules, containing 90 capsules per bottle, distributed by Proficient Rx LP. The label specifies that each capsule contains 100 mg of gabapentin, USP, and provides storage instructions (20°-25°C). The capsules are described as hard gelatin size 3 with white opaque cap and body, imprinted with "100 mg" and "IG321". Manufacturer is Ascent Pharmaceuticals, Inc., Central Islip, NY. Includes NDC 63187-392-90 and caution to keep medication out of reach of children.*

* 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.