Gabapentin Capsule
Product Images NDC 63187-909

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 63187-909). 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.

FDA Label Image

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A table titled 'Gabapentin Dosage Based on Renal Function' outlining dosage regimens based on creatinine clearance levels in mL/min. It includes total daily dose ranges, dose regimens (divided by frequency such as TID, BID, QD), and supplemental post-hemodialysis doses in mg. Footnotes explain dose adjustments for reduced renal function and hemodialysis patients.*

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An illustrated formula showing the calculation for creatinine clearance (CLCr), which includes variables such as age in years, weight in kilograms, serum creatinine in mg/dL, and a factor adjustment of 0.85 for female patients.*

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A table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' comparing event rates per 1000 patients between placebo and drug groups for epilepsy, psychiatric, and other indications. It includes columns for placebo events, drug events, relative risk, and risk difference per 1000 patients.*

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Data table presenting adverse reactions in pooled placebo-controlled trials for postherpetic neuralgia, comparing the incidence percentages between Gabapentin (N=336) and placebo (N=227). The table categorizes reactions under Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses.*

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Table showing adverse reactions in pooled placebo-controlled add-on trials for epilepsy patients over 12 years old, comparing gabapentin (N=543) and placebo (N=378). Reactions are categorized by body system, listing percentages for each group, including nervous system effects like somnolence, dizziness, and ataxia, digestive and respiratory symptoms, and others with frequencies for gabapentin and placebo groups.*

FDA Label Image

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A data table titled "Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years," comparing the percentage of adverse reactions in patients treated with Gabapentin and placebo. The table categorizes reactions by body system, including viral infection, fever, nausea, nervous system effects, and respiratory infections.*

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Chemical structure of gabapentin showing the cyclohexane ring attached to an amino group and a carboxymethyl group.*

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A table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing study details. It lists two studies with durations of 8 and 7 weeks, Gabapentin target doses ranging from 1800 to 3600 mg/day, and patient counts receiving Gabapentin and placebo for each study, including totals of 336 and 227 respectively.*

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A line graph comparing mean pain scores over an 8-week period for placebo versus Gabapentin administered at 3600 mg/day. The X-axis represents weeks including a baseline, with a 4-week dose titration period followed by a 4-week fixed dose period. The Y-axis shows mean pain scores ranging from 0 to 10. Gabapentin shows a decline in pain scores over time compared to placebo where scores remain relatively stable.*

FDA Label Image

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A line graph displaying mean pain scores over seven weeks for three groups: placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day. The x-axis represents time in weeks with baseline and two treatment periods, while the y-axis shows mean pain scores ranging from 0 to 10. The graph illustrates changes in pain scores over time by treatment group.*

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A bar chart titled 'Figure 3. Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing placebo (PBO) and gabapentin (GBP) doses in two studies. The chart shows percentages on the vertical axis, with Study 1 and Study 2 on the horizontal axis. Study 1 compares placebo to GBP 3600 mg; Study 2 compares placebo to GBP 1800 mg and GBP 2400 mg. Bars indicate higher responder percentages for gabapentin doses compared to placebo, with significance levels noted.*

FDA Label Image

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A scatter plot depicting percentage difference on the y-axis versus daily dose in mg on the x-axis for Gabapentin. Data points represent three studies labeled 'STUDY a,' 'STUDY b,' and 'STUDY c' across daily doses of 600, 900, 1200, and 1800 mg. Each study is indicated with distinct markers, showing varying differences at different doses.*

FDA Label Image

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Label for Gabapentin 400 mg capsules, packaged in a bottle with 90 count. The label shows the product name, strength, quantity, and that it is RX only. The capsules are described as hard gelatin size 0 with orange opaque cap and body, imprinted with 400 mg and IG323, containing white to off-white powder. The label indicates the manufacturer as InvaGen Pharmaceuticals, Inc., a subsidiary of Cipla Ltd., and the labeler as Proficient Rx LP of Thousand Oaks, CA. Storage instructions and safety warnings to keep medication out of reach of children are included.*

* 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.