Gabapentin
Product Images NDC 68071-3472

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 68071-3472). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare 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

Pdp (68071 3472 9)

Gabapentin 800 mg tablets from NuCare Pharmaceuticals, Inc. The label shows that the package contains 90 oval-shaped, white biconvex tablets debossed with 'T' on the left side and '3' on the right side. The product is prescription only (Rx Only) and the label includes storage instructions to keep at controlled temperature 68-77°F and a warning to keep out of reach of children. The label also provides lot, expiration information, and a FDA contact number for reporting side effects.*

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Sideeffects (Sideeffects)

A text panel listing potential side effects or symptoms associated with a medication. The listed symptoms include lack of coordination, viral infection, difficulty with speaking, tremor, swelling 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)

Table displaying gabapentin dosage adjustments based on renal function measured by creatinine clearance (mL/min). Dosage ranges (mg/day), detailed daily dose regimens (mg) for various frequencies (TID, BID, QD), and post-hemodialysis supplemental doses (mg) are presented according to renal function categories. Notes clarify dose reductions for patients with creatinine clearance below 15 mL/min and maintenance dosing for hemodialysis patients.*

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Table-2 (Table2)

A table titled "Risk by Indication for Antiepileptic Drugs in the Pooled Analysis" comparing placebo and drug patient event rates per 1,000 patients across epilepsy, psychiatric, and other indications, along with relative risk and risk difference values for antiepileptic drugs.*

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Table-3 (Table3)

Data table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing the percentage of adverse reactions reported in Gabapentin (N=336) versus placebo (N=227). It categorizes reactions by body system including Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, listing corresponding percentages for each adverse reaction in both groups.*

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Table-4 (Table4)

A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Add-On Trials in Epilepsy Patients >12 years of age' comparing frequency percentages of adverse reactions between Gabapentin (N=543) and Placebo (N=378) groups. Categories include Body As A Whole, Cardiovascular, Digestive System, Nervous System, Respiratory System, Skin and Appendages, Urogenital System, and Special Senses, showing specific adverse effects and their respective occurrence rates.*

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Table-5 (Table5)

Data table showing adverse reactions observed in a placebo-controlled add-on trial of gabapentin versus placebo in pediatric epilepsy patients aged 3 to 12 years. The table details percentages of patients experiencing various effects across body systems including viral infection, fever, increased weight, fatigue, digestive symptoms, nervous system effects, and respiratory issues.*

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Table-6 (Table6)

A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' presenting details for two studies. Columns include Study, Study Duration (8 weeks and 7 weeks), Gabapentin Target Dose in mg/day (3600; 1800, 2400), number of Patients Receiving Gabapentin (113 and 223), and Patients Receiving Placebo (116 and 111). A footnote indicates doses were given in three divided doses (TID).*

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Clcr (Clcr)

An illustration depicting a formula for calculating creatinine clearance (CLCr). The formula includes variables for age (years), weight (kg), serum creatinine (mg/dL), and a multiplication factor of 0.85 for female patients, representing an adjustment in the calculation.*

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Figure-1 (Figure1)

A line graph showing weekly mean pain scores over 8 weeks for two groups in a study. The X-axis represents weeks, including a baseline, with an initial 4-week dose titration period followed by a 4-week fixed dose period. The Y-axis shows mean pain scores ranging from 0 to 10. One line represents placebo with higher consistent pain scores around 6, and the other line represents Gabapentin 3600 mg/day with decreasing pain scores from about 6 to about 4 over the study 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 for placebo and two dosages of Gabapentin (1800 mg/day and 2400 mg/day). The x-axis represents weeks from baseline to week 7, and the y-axis represents mean pain scores from 0 to 10. The graph includes a 3-week dose titration period followed by a 4-week fixed dose period. Placebo scores remain higher, with Gabapentin groups showing lower and gradually decreasing mean pain scores over time.*

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Figure-3 (Figure3)

Bar chart titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing placebo (PBO) and Gabapentin (GBP) doses in two studies. Study 1 shows 12% responders for PBO and 29% for GBP 3600. Study 2 shows 14% responders for PBO, 32% for GBP 1800, and 34% for GBP 2400. Statistical significance is indicated with p-values <0.01 and <0.001.*

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Figure-4 (Figure4)

A scatter plot chart titled 'Responder Rate in Patients Receiving Gabapentin Expressed as a Difference from Placebo by Dose and Study.' It shows the difference in responder rates (%) on the vertical axis against daily gabapentin dose (mg) on the horizontal axis for patients aged 12 years or older with partial seizures. Data points from three studies are distinguished by different square colors and labeled as Study a, Study b, and Study c.*

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Struc (Struct)

Chemical structure of gabapentin showing a cyclohexane ring attached to a side chain with amine (CH2NH2) and carboxylic acid (CH2CO2H) functional 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.