Gabapentin Tablet
Product Images NDC 68788-8488

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 68788-8488). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Preferred 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

Gabapentin Tab 600mg Cv Ascent (35da078b 0da0 4757 A6c4 A9144c37e8e1 00)

Label for Gabapentin tablets 600 mg (CV) by Preferred Pharmaceuticals Inc. The label states Gabapentin as the generic name and indicates it is a generic for Neurontin. It includes spaces for package size, expiration date, lot and batch numbers, and insurance information. Directions are provided in both English and Spanish with blank fields for dosage instructions. The manufacturer is listed as Ascent Pharmaceuticals, Inc.*

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Sideeffects (Sideeffects)

A text panel listing potential side effects or symptoms associated with a medication, including lack of coordination, viral infection, difficulty with speaking, tremor, swelling usually of legs and feet, feeling tired, fever, feeling drowsy, nausea and vomiting, jerky movements, difficulty with coordination, double vision, and unusual eye movement.*

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Table-1 (Table1)

A table titled 'Gabapentin Dosage Based on Renal Function' showing recommended total daily dose ranges and dose regimens for gabapentin based on different creatinine clearance levels in mL/min. It includes specific doses for various regimens such as TID and BID, and a section for post-hemodialysis supplemental doses. Footnotes clarify dose adjustments for patients with creatinine clearance below 15 mL/min and dosing guidance for hemodialysis patients.*

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Table-2 (Table2)

A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis,' presenting comparative statistics for placebo and drug patients across four indication categories (Epilepsy, Psychiatric, Other, Total). It includes columns for events per 1,000 patients, relative risk, and risk difference for antiepileptic drugs.*

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Table-3 (Table3)

Data table presenting adverse reactions in pooled placebo-controlled trials for postherpetic neuralgia comparing Gabapentin (336 participants) and placebo (227 participants). It lists percentages of various side effects by body system, including nervous system effects like dizziness (28% Gabapentin vs. 8% placebo) and somnolence (21% vs. 5%).*

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Table-4 (Table4)

Data table presenting adverse reactions from pooled placebo-controlled add-on trials in epilepsy patients aged over 12. It compares the incidence percentages of various side effects between Gabapentin (N=543) and placebo (N=378) across body systems including nervous, digestive, respiratory, cardiovascular, skin, urogenital, and special senses.*

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Table-5 (Table5)

A data table showing adverse reactions in a placebo-controlled add-on trial in pediatric epilepsy patients aged 3 to 12 years, comparing Gabapentin (N=119) with placebo (N=128). Categories include body as a whole, digestive system, nervous system, and respiratory system, listing specific reactions and their respective percentages in each group.*

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Table-6 (Table6)

A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' summarizes two studies. It lists study duration (8 and 7 weeks), gabapentin target doses (3600 mg/day and 1800 or 2400 mg/day), and the number of patients receiving gabapentin (113 and 223) or placebo (116 and 111). A footnote notes gabapentin doses given in three divided doses (TID).*

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Clcr (Clcr)

An illustration showing a formula to calculate Creatinine Clearance (CLCr). The formula includes variables for age in years, weight in kilograms, serum creatinine in mg/dL, and an adjustment factor of 0.85 for female patients.*

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Figure-1 (Figure1)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1' compares mean pain scores over 8 weeks between Placebo and Gabapentin 3600 mg/day groups. The x-axis shows weeks from Baseline to 8; the y-axis shows mean pain score from 0 to 10. The Gabapentin group demonstrates a decreasing pain score trend, while the Placebo group remains relatively stable. The graph is divided into two 4-week periods labeled 'Dose Titration' and 'Fixed Dose.'*

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Figure-2 (Figure2)

Line chart titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2', showing mean pain scores over 7 weeks. The x-axis is labeled 'Weeks' and y-axis labeled 'Mean Pain Score' from 0 to 10. It compares three groups: Placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day over a 3-week dose titration period followed by a 4-week fixed dose period.*

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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 placebo (PBO) and gabapentin (GBP) treatment groups. Two studies are shown: Study 1 with 12% responders for placebo and 29% for GBP 3600 mg; Study 2 with 14% responders for placebo, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance is indicated for gabapentin groups.*

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Figure-4 (Figure4)

A scatter plot showing responder rate differences from placebo by daily dose (600 mg to 1800 mg) for gabapentin in adjunctive therapy studies of patients aged 12 years or older with partial seizures. Data points distinguish three studies labeled a, b, and c, with responder rates ranging from about 8% to 18%.*

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Struc (Struct)

Chemical structure of gabapentin showing a cyclohexane ring attached to aminomethyl and acetic acid groups.*

* 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.