Gabapentin Tablet
Product Images NDC 71610-621

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 71610-621). 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 600 mg (71610 0621 30)

GABAPENTIN 600 mg oral tablets packaging label showing 30 tablets per container. The label includes storage instructions (store between 20-25 degrees Celsius), manufacturer details (Ascent Pharmaceuticals, Inc. and Aphena Pharma Solutions - Tennessee, LLC), and regulatory information including the NDC code 71610-0621-30. The label is primarily black text on a white background with barcode and QR code.*

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Aphena Pharma Solutions (TN)

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Sideeffects (Sideeffects)

A text panel listing potential side effects including lack of coordination, viral infection, difficulty with speaking, tremor, swelling usually in 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)

Table showing Gabapentin dosage based on renal function categorized by creatinine clearance levels in mL/min, with corresponding total daily dose ranges (mg/day) and dose regimens (mg) in divided doses such as TID, BID, and QD. The table also includes post-hemodialysis supplemental doses (mg) with footnotes explaining dosing adjustments for patients with creatinine clearance under 15 mL/min and recommendations for hemodialysis patients.*

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Table-2 (Table2)

Table presenting risk by indication for antiepileptic drugs in a pooled analysis. Columns compare placebo and drug patients with events per 1,000 patients, relative risk of events in drug versus placebo patients, and risk difference in additional drug patients with events per 1,000 patients, segmented by indications including epilepsy, psychiatric, other, and total.*

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Table-3 (Table3)

Table showing adverse reactions reported in pooled placebo-controlled trials for gabapentin versus placebo in postherpetic neuralgia. The table lists reactions by body system category with percentages of patients experiencing each event in gabapentin (N=336) and placebo (N=227) groups, including nervous system effects like dizziness and somnolence, metabolic disorders like peripheral edema, and digestive symptoms.*

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Table-4 (Table4)

A data table presenting adverse reactions in pooled placebo-controlled add-on trials for epilepsy patients aged over 12 years. It compares percentages of various side effects between Gabapentin (N=543) and placebo (N=378) groups, organized by body system categories such as body as a whole, cardiovascular, digestive, nervous, respiratory, skin and appendages, urogenital, and special senses.*

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Table-5 (Table5)

A table listing adverse reactions in a placebo-controlled add-on trial of Gabapentin in pediatric epilepsy patients aged 3 to 12 years, comparing the percentage of patients experiencing specific side effects between Gabapentin (N=119) and placebo (N=128) groups across various body systems including whole body, digestive, nervous, and respiratory systems.*

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Table-6 (Table6)

A data table titled 'TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing two studies with details including study duration, gabapentin target dose in mg/day, and the number of patients receiving gabapentin or placebo for each study and total counts.*

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Clcr (Clcr)

An equation illustrating the formula for calculating creatinine clearance (CLCr). It includes variables such as age (years), weight (kg), serum creatinine (mg/dL), and a factor adjustment of 0.85 for female patients. This formula helps estimate kidney function.*

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Figure-1 (Figure1)

A line graph showing weekly mean pain scores over 8 weeks in an ITT population from Study 1. It compares placebo and Gabapentin 3600 mg/day treatments during a 4-week dose titration period followed by a 4-week fixed dose period, with pain scores on the y-axis and weeks on the x-axis.*

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Figure-2 (Figure2)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2' showing changes in mean pain scores over seven weeks. The x-axis represents weeks with a baseline and the y-axis shows mean pain scores ranging from 0 to 10. The graph compares three groups: placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day, during a 3-week dose titration period followed by a 4-week fixed dose period.*

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Figure-3 (Figure3)

Bar chart showing the proportion of responders (patients with ≥50% reduction in pain score) at endpoint from two controlled PHN studies. Study 1 compares placebo (12%) to Gabapentin 3600 mg (29%), while Study 2 compares placebo (14%) to Gabapentin 1800 mg (32%) and 2400 mg (34%). Statistical significance is indicated by p-values below 0.01 and 0.001.*

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Figure-4 (Figure4)

A scatter plot graph showing the responder rate difference from placebo by daily dose of Gabapentin in adjunctive therapy studies for patients aged 12 years and older with partial seizures. The x-axis shows daily dose in mg (600, 900, 1200, 1800), and the y-axis shows difference in responder rate (%). Data points represent results from three studies labeled a, b, and c, each indicated by different shading and letter annotations next to the points.*

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Struc (Struct)

Chemical structure of gabapentin showing a cyclohexane ring bonded to an aminomethyl group (CH2NH2) and an acetic acid group (CH2CO2H).*

* 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.