Gabapentin Capsule
Product Images NDC 76420-020

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 76420-020). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Asclemed Usa, 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.

FDA Label Image

Image (300mg)

Labels for Gabapentin Capsules USP 300 mg in various quantities (24, 30, 60, 90 capsules) packaged by Enovachem Pharmaceuticals. Each label displays NDC codes, quantity, manufacturing and packaging details, barcodes, and a caution statement regarding prescription use and storage instructions. The capsules are described as yellow, and the labels note manufacturing for Cipla USA, Inc.*

FDA Label Image

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A table titled "Gabapentin Dosage Based on Renal Function" presenting dosage regimens of Gabapentin capsules, 300 mg strength, based on patients' renal function measured by creatinine clearance (mL/min). It lists total daily dose ranges and corresponding dose regimens in mg, differentiated by dosing frequency: TID, BID, QD. The table includes supplemental dosing for post-hemodialysis patients and explanatory notes on dosing adjustments for creatinine clearance below 15 mL/min and equations for estimating creatinine clearance in stable renal function patients.*

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A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' showing comparative risk data between placebo and drug patients across indications including epilepsy, psychiatric, other, and total. Columns display events per 1,000 patients for both placebo and drug groups, relative risk, and risk difference for additional drug patients with events per 1,000 patients.*

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A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' showing the percentage of various adverse reactions for Gabapentin (N=336) and placebo (N=227). Reactions are grouped by system including body as a whole, digestive system, metabolic and nutritional disorders, nervous system, respiratory system, and special senses, with specific adverse reactions like asthenia, diarrhea, dizziness, somnolence, and blurred vision. The table compares these reactions' frequencies between Gabapentin and placebo groups.*

FDA Label Image

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Data table titled 'Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epilepsy Patients >12 years of age' for Gabapentin versus placebo. It lists percentages of various adverse reactions across body systems such as Nervous System, Digestive System, Cardiovascular, Respiratory System, and others, reported in groups of 543 Gabapentin-treated and 378 placebo patients. Specific reactions include fatigue, somnolence, dizziness, tremor, and diplopia, among others.*

FDA Label Image

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A table titled 'Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years.' It compares the percentage of various adverse reactions in patients treated with Gabapentin (N=119) versus Placebo (N=128). Categories include Body As A Whole, Digestive System, Nervous System, and Respiratory System, with specific reactions such as viral infection, fever, nausea, somnolence, and bronchitis listed and their corresponding percentages for both groups.*

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Chemical structure of gabapentin showing a cyclohexane ring attached to an amino group and an acetic acid side chain. This structural formula corresponds to the active ingredient gabapentin.*

FDA Label Image

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A table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' summarizing two studies. Columns include Study number, Study Duration (7-8 weeks), Gabapentin target doses in mg/day (1,800 to 3,600), and counts of patients receiving Gabapentin (113 and 223) or placebo (116 and 111). A footnote states that Gabapentin was given in 3 divided doses (TID).*

FDA Label Image

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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, including baseline, while the y-axis shows the mean pain score from 0 to 10. The graph indicates a 4-week dose titration period followed by a 4-week fixed dose period, with Gabapentin showing a decrease in pain scores compared to placebo.*

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Line graph showing mean pain scores over seven weeks during a 3-week dose titration period followed by a 4-week fixed dose period. The graph compares placebo with Gabapentin at 1800 mg/day and 2400 mg/day doses, illustrating changes in mean pain scores over time.*

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A bar chart titled 'Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing placebo (PBO) and gabapentin (GBP) at different doses across two studies. It shows percentage responders on the vertical axis, with study 1 comparing PBO and GBP 3600 mg, and study 2 comparing PBO, GBP 1800 mg, and GBP 2400 mg, indicating higher response rates for gabapentin doses versus placebo with statistical significance noted.*

FDA Label Image

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A scatter plot illustrating the percentage difference versus daily dose in milligrams for gabapentin in three different studies labeled a, b, and c. The x-axis shows doses from 600 mg to 1800 mg, and the y-axis shows percentage differences from 2% to 22%. Each study's data points are marked with distinct symbols corresponding to the studies.*

* 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.