Gabapentin Tablet
Product Images NDC 72865-256

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 72865-256). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare Pharmaceuticals, 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

500-600 (600 500)

Label for Gabapentin Tablets USP 600 mg by XLCare Pharmaceuticals, Inc. The label indicates 500 oral tablets with prescription only status. It includes storage instructions and manufacturing details from Ascent Pharmaceuticals, Inc. and XLCare Pharmaceuticals, Inc.*

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90-600 (600 90)

Label for GABAPENTIN Tablets, USP 600 mg, oral tablets by XL Care Pharmaceuticals, Inc. The label shows that the package contains 90 tablets and is for prescription use only. It includes storage instructions, manufacturing information by Ascent Pharmaceuticals and XL Care Pharmaceuticals, and notes that each tablet contains 600 mg of gabapentin.*

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500-800 (800 500)

Label for Gabapentin Tablets, USP 800 mg oral tablets by XLCare Pharmaceuticals, Inc. The package contains 500 tablets. The label includes storage instructions, dosage details, manufacturer information, and states the product is Rx only.*

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90-800 (90 800)

Label for Gabapentin Tablets USP, 800 mg, oral tablets, by XLCare Pharmaceuticals, Inc. The package contains 90 tablets and is prescription only. Storage instructions and manufacturer information for Ascent Pharmaceuticals, Inc. and XLCare Pharmaceuticals, Inc. are included along with an NDC barcode.*

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Sideeffects (Sideeffects)

This image shows a bulleted list of potential side effects, including lack of coordination, viral infection, difficulty with speaking, tremor, swelling usually of legs and feet, fatigue, fever, drowsiness, nausea and vomiting, jerky movements, difficulty with coordination, double vision, and unusual eye movement.*

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Table-1 (Table1)

Data table titled 'Gabapentin Dosage Based on Renal Function' showing dose ranges and regimens of gabapentin based on creatinine clearance levels (mL/min) ranging from 15 to ≥60, including total daily dose range (mg/day), dose regimens (mg) for different strengths (300 to 1200 mg TID), and a section for post-hemodialysis supplemental doses (mg).*

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Table-2 (Table2)

A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' summarizing the incidence of events per 1,000 patients for placebo and drug groups across indications including epilepsy, psychiatric, and other. The table includes columns for placebo events, drug events, relative risk, and additional drug patient events per 1,000 patients.*

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Table-3 (Table3)

A table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing the incidence percentages of various adverse reactions for Gabapentin (N=336) and placebo (N=227). The reactions are categorized by body system including Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, with specific conditions and their reported rates for each group.*

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Table-4 (Table4)

Table showing adverse reactions in pooled placebo-controlled add-on trials in epilepsy patients over 12 years of age, comparing Gabapentin (N=543) and placebo (N=378). It lists percentages of various side effects by body system, including nervous system (e.g., somnolence, dizziness), digestive, cardiovascular, respiratory, skin, urogenital, and special senses.*

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Table-5 (Table5)

Table showing adverse reactions in a placebo-controlled add-on trial in pediatric epilepsy patients aged 3 to 12 years. It compares the percentages of various side effects, such as viral infection, fever, increased weight, fatigue, nausea, somnolence, hostility, emotional lability, dizziness, hyperkinesia, bronchitis, and respiratory infection, between patients treated with gabapentin and placebo groups.*

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Table-6 (Table6)

A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing study number, study duration, gabapentin target dose in mg/day, and the number of patients receiving gabapentin or placebo across two studies. Study 1 lasted 8 weeks with a 3600 mg/day dose; Study 2 lasted 7 weeks with doses of 1800 and 2400 mg/day.*

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Clcr (Clcr)

An illustrated formula for calculating creatinine clearance (CLCr), showing the equation involving age in years, weight in kilograms, serum creatinine in mg/dL, and an adjustment factor for female patients. This diagram explains a pharmacokinetic calculation relevant to drug dosing.*

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Figure-1 (Figure1)

A line graph titled 'Weekly Mean Pain Scores' comparing mean pain scores over eight weeks between placebo and Gabapentin 3600 mg/day in a clinical study. The y-axis shows mean pain scores from 0 to 10, and the x-axis shows weeks from baseline to week 8. It includes a 4-week dose titration period followed by a 4-week fixed dose period. Gabapentin shows a decreasing trend in mean pain scores, while placebo remains relatively stable.*

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Figure-2 (Figure2)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2' comparing mean pain scores over 7 weeks among three groups: placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day. The x-axis represents weeks from baseline to week 7, and the y-axis shows mean pain scores from 0 to 10. The study includes a 3-week dose titration period followed by a 4-week fixed dose period. The graph shows decreasing mean pain scores over time for both gabapentin groups compared to placebo.*

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Figure-3 (Figure3)

A bar graph titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing response rates across two studies. Study 1 shows 12% for placebo (PBO) and 29% for GBP 3600. Study 2 shows 14% for placebo, 32% for GBP 1800, and 34% for GBP 2400, with statistical significance noted.*

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Figure-4 (Figure4)

A scatter plot chart showing responder rate differences from placebo by daily gabapentin dose (mg) in adjunctive therapy studies for patients aged 12 years and older with partial seizures. The y-axis displays percentage difference, and the x-axis shows daily doses from 600 to 1800 mg. Data points for three studies (a, b, c) are marked with distinct colored squares representing differences at various doses.*

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Struc (Struct)

Chemical structure diagram of gabapentin, showing a cyclohexane ring with amino and carboxyl functional groups attached, representing the active ingredient gabapentin.*

* 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.