Gabapentin Tablet
Product Images NDC 71610-630

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 71610-630). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, 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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Bottle Label 800 mg (71610 0630 80)

Label for Gabapentin, USP 800 mg oral tablets, containing 180 tablets per container. The label displays the NDC number 71610-0630-80, storage instructions, manufacturer information (Ascent Pharmaceuticals, Inc.), and repackager details (Aphena Pharma, Cookeville, TN). The label indicates this is an Rx-only product.*

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Aphena Pharma Solutions (TN)

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Sideeffects (Sideeffects)

Drug information text listing potential side effects 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 dosage adjustments based on renal function measured by creatinine clearance in mL/min. The table presents total daily dose ranges in mg/day and specific dose regimens in mg (TID, BID, QD) for various renal function categories. It also includes supplemental post-hemodialysis doses in mg with explanatory footnotes on dosage adjustments for patients with reduced renal function and those undergoing hemodialysis.*

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Table-2 (Table2)

Data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' presenting comparative risk metrics for epilepsy, psychiatric, and other indications. Columns show events per 1,000 patients for placebo and drug groups, relative risk ratios, and risk difference values for antiepileptic drug patients versus placebo patients.*

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Table-3 (Table3)

A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing the percentage of various adverse reactions reported in patients treated with Gabapentin (N=336) versus placebo (N=227). Adverse reactions are grouped by body system, such as Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, showing higher percentages for Gabapentin in most categories.*

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Table-4 (Table4)

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

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Table-5 (Table5)

A data table titled 'Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years' comparing percentages of adverse reactions between gabapentin (N=119) and placebo (N=128) groups. Categories include Body as a Whole, Digestive System, Nervous System, and Respiratory System with specific reactions and their respective percentage incidences.*

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Table-6 (Table6)

A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' presenting information on two studies. It lists study duration, gabapentin target doses in mg/day, and patient counts receiving gabapentin or placebo, with totals provided. Gabapentin doses noted are divided into three daily doses (TID).*

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Clcr (Clcr)

A formula calculation panel illustrating creatinine clearance (CLCr). The formula includes age in years, weight in kilograms, serum creatinine in mg/dL, and a factor of 0.85 for female patients. This mathematical expression is typically used to estimate kidney function.*

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Figure-1 (Figure1)

A line chart showing weekly mean pain scores over 8 weeks in a study population. The x-axis represents weeks from baseline to week 8, and the y-axis represents mean pain scores from 0 to 10. Two lines compare placebo (circles) and gabapentin 3600 mg/day (triangles), showing a decrease in pain scores over time for gabapentin versus relatively stable scores for placebo. The chart notes a 4-week dose titration period followed by a 4-week fixed dose period.*

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Figure-2 (Figure2)

A line graph 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' from baseline to week 7, and the y-axis is labeled 'Mean Pain Score' from 0 to 10. The graph compares three groups: Placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day, with dose titration and fixed-dose periods indicated. Gabapentin groups show a decrease in pain scores over time compared to placebo.*

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Figure-3 (Figure3)

A bar chart titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies.' It compares placebo (PBO) versus Gabapentin (GBP) at doses of 1800, 2400, and 3600 mg across two studies. The chart shows higher response percentages for gabapentin groups compared to placebo, with statistical significance indicated (** p<0.01, *** p<0.001).*

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Figure-4 (Figure4)

A scatter plot showing responder rates in patients receiving gabapentin versus placebo, expressed as percentage difference by daily dose (600, 900, 1200, 1800 mg) from three studies (a, b, c) for adjunctive therapy in patients aged 12 and older with partial seizures. Each study is represented by different colored squares indicating varied responder rates across doses.*

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Struc (Struct)

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

* 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.