Gabapentin
Product Images NDC 83008-063

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 83008-063). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Quality Care Products, 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.

FDA Label Image

Image Description (Camscanner 06 14 2024 09.58)

GABAPENTIN 600 mg tablets label by Quality Care Products, LLC. The label states 30 tablets per bottle, with each tablet containing 600 mg of gabapentin. Includes storage instructions to keep at 77 degrees Fahrenheit and warns to keep medication out of reach of children. Manufactured by Ascent Pharmaceuticals, Inc. and labeled for Camber Pharmaceuticals, Inc.*

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Sideeffects (Sideeffects)

A text panel listing symptoms or 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)

Data table titled 'Gabapentin Dosage Based on Renal Function' showing dose regimens based on creatinine clearance levels (mL/min). It includes total daily dose ranges (mg/day) and dose regimens in mg with frequencies (TID, BID, QD). The table also provides supplemental post-hemodialysis doses with explanatory footnotes for dose adjustments based on renal function and hemodialysis timing.*

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Table-2 (Table2)

A data table titled 'Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' comparing placebo and drug patients with events per 1,000 patients across epilepsy, psychiatric, and other indications. The table includes columns for relative risk and risk difference for additional drug patients with events per 1,000.*

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Table-3 (Table3)

Table displaying adverse reactions in pooled placebo-controlled trials for postherpetic neuralgia comparing gabapentin (N=336) and placebo (N=227) groups. It lists percentages of reported symptoms by body system, including body as a whole, digestive system, metabolic/nutritional disorders, nervous system, respiratory system, and special senses, showing higher percentages generally in the gabapentin group.*

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Table-4 (Table4)

A table listing adverse reactions from pooled placebo-controlled add-on trials in epilepsy patients age 12 or older. It compares the percentage of side effects reported with Gabapentin (N=543) versus placebo (N=378) across body systems, including fatigue, nervous system symptoms like somnolence and dizziness, digestive and respiratory effects, and others such as diplopia and amnesia.*

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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 incidence percentages of various adverse reactions between Gabapentin (N=119) and Placebo (N=128) groups. Categories include Body as a Whole, Digestive System, Nervous System, and Respiratory System, listing specific reactions like viral infection, fever, nausea, somnolence, hostility, and bronchitis.*

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Table-6 (Table6)

A data table labeled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing two studies. It includes columns for study duration (8 and 7 weeks), gabapentin target doses (3600 mg/day for study 1, 1800 and 2400 mg/day for study 2), and numbers of patients receiving gabapentin (113 and 223) and placebo (116 and 111). Total patients receiving gabapentin are 336 and placebo 227.*

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Clcr (Clcr)

Illustration showing the formula for calculating creatinine clearance (CLCr), featuring variables including age, weight, serum creatinine, and a factor adjustment for female patients.*

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Figure-1 (Figure1)

A line graph titled "Weekly Mean Pain Scores" showing mean pain scores over 8 weeks comparing placebo and gabapentin 3600 mg/day. The x-axis represents weeks including baseline, while the y-axis shows mean pain scores from 0 to 10. Two periods are indicated: a 4-week dose titration and a 4-week fixed dose. Gabapentin shows a decreasing trend in pain scores compared to placebo, which remains relatively constant.*

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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 seven weeks for placebo and two dosages of gabapentin (1800 mg/day and 2400 mg/day). The graph shows mean pain scores on the vertical axis (0 to 10) and weeks on the horizontal axis, divided into a 3-week dose titration period and a 4-week fixed dose period.*

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Figure-3 (Figure3)

Bar chart showing the proportion of responders (patients with at least 50% reduction in pain score) at endpoint in controlled PHN studies. It compares placebo (PBO) and gabapentin (GBP) at various doses (3600 mg in Study 1; 1800 mg and 2400 mg in Study 2), illustrating higher responder percentages for gabapentin groups with statistical significance indicated.*

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Figure-4 (Figure4)

A bar chart titled 'Responder Rate in Patients Receiving Gabapentin Expressed as a Difference from Placebo by Dose and Study' shows differences in responder rates by daily dose (600, 900, 1200, 1800 mg) in three studies labeled a, b, and c in patients aged 12 and older with partial seizures. The y-axis represents difference percentage, ranging up to 22%.*

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Struc (Struct)

Chemical structure of gabapentin, showing a cyclohexane ring attached to an aminomethyl group and an acetic acid 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.