Gabapentin Capsule
Product Images NDC 60760-669

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 60760-669). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by St. Mary's Medical Park Pharmacy, 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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Equation (Equ)

An illustration showing the formula for calculating creatinine clearance (CLCr), which includes variables for age, weight, serum creatinine, and a factor for female patients. This formula is used in medical contexts but is not specific to any drug product.*

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Fig 1 (Fig 1)

A line graph titled 'Weekly Mean Pain Scores' displaying mean pain scores over 8 weeks in a study population. The x-axis represents weeks from baseline to 8, and the y-axis shows mean pain scores ranging from 0 to 10. Two lines compare placebo and gabapentin (3600 mg/day), showing gabapentin with a decreasing pain score trend over time versus a relatively stable score for placebo.*

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Fig 2 (Fig 2)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2' showing mean pain scores over 7 weeks. It compares three groups: placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day, with mean pain scores decreasing over time for gabapentin groups compared to placebo.*

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Fig 3 (Fig 3)

A bar chart titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing the percentage of responders between placebo (PBO) and gabapentin (GBP) doses across two studies. Study 1 shows 12% responders for placebo and 29% for GBP 3600 mg. Study 2 shows 14% for placebo, 32% for GBP 1800 mg, and 34% for GBP 2400 mg, with statistical significance indicated.*

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Fig 4 (Fig 4)

A bar chart showing responder rates expressed as a difference from placebo in percentage among patients aged 12 years and older with partial seizures, across three studies labeled a, b, and c. The x-axis represents daily doses of gabapentin in milligrams (600, 900, 1200, 1800 mg), and the y-axis shows the percentage difference in response rate.*

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60760-669 (Gabapentin 100mg 60760 669 90)

Label for Gabapentin capsules USP 100 mg, package quantity 60. The label includes the product NDC 60760-669-60, manufacturer Hetero in Kolar, India, and is packaged by St. Mary's Medical Park Pharmacy in Oro Valley, AZ. The label shows dosage form as capsules and provides storage instructions for controlled room temperature (15°-30°C).*

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Structure (Struct)

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

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Table 1 (Tab 1)

Table titled 'Gabapentin Dosage Based on Renal Function' detailing dose regimens for gabapentin capsules based on creatinine clearance levels. It provides total daily dose ranges and specific dosing schedules (QD, BID, TID) for various renal function categories, including guidance for patients undergoing hemodialysis with supplemental post-hemodialysis doses. Abbreviations and footnotes explain dosing adjustments related to renal clearance and hemodialysis.*

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Table 2 (Tab 2)

A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' comparing placebo patients and drug patients with events per 1,000 patients across epilepsy, psychiatric, and other indications. It also presents relative risk and risk difference for these categories and totals.*

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Table 3 (Tab 3)

A data table titled 'TABLE 3. Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing the incidence percentages of adverse reactions between gabapentin and placebo groups. Reactions are categorized by body system, including Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses.*

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Table 4 (Tab 4)

Table showing adverse reactions in pooled placebo-controlled add-on trials in epilepsy patients over 12 years old, comparing gabapentin (N=543) and placebo (N=378). The table lists the incidence percentages of side effects by body system, including nervous system effects like somnolence and dizziness, and others such as digestive and cardiovascular symptoms.*

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Table 5 (Tab 5)

A table titled 'Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years.' It compares the frequency of various adverse reactions for gabapentin versus placebo groups, listing reactions by body system including viral infection, fever, increased weight, fatigue, nausea, somnolence, hostility, and others.*

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Tab 6 (Tab 6)

A table titled 'TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients' listing study duration, gabapentin target dose in mg/day, number of patients receiving gabapentin, and number receiving placebo for two studies. The studies lasted 8 and 7 weeks, with doses ranging from 1800 to 3600 mg/day divided in 3 doses.*

* 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.