Gabapentin Tablet
Product Images NDC 76420-837

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 76420-837). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Asclemed Usa, 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

600 mg (600mg Label)

Packaging labels for Gabapentin Tablets USP 600 mg by Enovachem Pharmaceuticals, with NDC codes 76420-836-30, -60, and -90 representing quantities of 30, 60, and 90 tablets respectively. The labels include manufacturer details for Camber Pharmaceuticals, Inc., barcode, lot and batch information, and storage instructions. Additional labels show relabeled quantities of 100 and 500 tablets with corresponding NDC codes 76420-836-01 and 76420-836-05.*

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800 mg (800 mg Label)

Packaging labels for Gabapentin Tablets, USP 800 mg oral tablets by Enovachem Pharmaceuticals. Labels indicate different package quantities including 30, 60, 90, 100, and 500 tablets. Each label includes the NDC, manufacturing details for Camber Pharmaceuticals, lot and expiration placeholders, and storage instructions.*

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Sideeffects (Sideeffects)

A portion of a drug information panel listing possible side effects or symptoms related to a medication. The visible text includes symptoms such as 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)

Table showing Gabapentin dosage adjustments based on renal function measured by creatinine clearance (mL/min). It lists total daily dose ranges (mg/day), dose regimens (mg) at various frequencies (TID, BID, QD), and post-hemodialysis supplemental doses (mg). Footnotes explain dose reductions for creatinine clearance below 15 mL/min and maintenance plus supplemental dosing for patients on hemodialysis.*

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Table-2 (Table2)

A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' presenting risk statistics including events per 1,000 patients for placebo and drug groups, relative risk, and risk difference across indications such as Epilepsy, Psychiatric, Other, and Total.*

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Table-3 (Table3)

A table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' listing adverse reaction rates (%) for Gabapentin (N=336) versus Placebo (N=227). Reactions are grouped by body system including Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, showing percent incidence for each reaction such as asthenia, dizziness, somnolence, peripheral edema, and others.*

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Table-4 (Table4)

Table displaying adverse reactions reported in pooled placebo-controlled add-on trials of Gabapentin versus placebo in epilepsy patients aged over 12 years. The table categorizes reactions by body systems such as nervous, digestive, cardiovascular, respiratory, and others, showing percentage incidences for each group (Gabapentin N=543, Placebo N=378).*

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Table-5 (Table5)

A table showing adverse reactions in a placebo-controlled add-on trial in pediatric epilepsy patients aged 3 to 12 years. It compares the percentage of patients experiencing various adverse reactions between those treated with gabapentin (N=119) and placebo (N=128), across categories including body as a whole, digestive system, nervous system, and respiratory system.*

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Table-6 (Table6)

A data table titled "Controlled PHN Studies: Duration, Dosages, and Number of Patients" showing study number, study duration, gabapentin target dose in mg/day, number of patients receiving gabapentin, and number of patients receiving placebo across two studies. Dosages are given in divided doses (TID).*

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Clcr (Clcr)

An illustration showing the formula for calculating creatinine clearance (CLCr), which 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' showing mean pain scores over 8 weeks in a study population. It compares placebo and Gabapentin at 3600 mg/day, displaying a decline in pain scores over time, with Gabapentin showing a greater decrease than placebo. The x-axis represents weeks from baseline to week 8, and the y-axis represents mean pain scores ranging from 0 to 10.*

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Figure-2 (Figure2)

A line graph depicting weekly mean pain scores over 7 weeks in a study with three groups: placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day. The x-axis shows weeks from baseline to week 7, and the y-axis shows mean pain scores from 0 to 10. The graph includes a 3-week dose titration period followed by a 4-week fixed dose period, illustrating pain score trends for each group.*

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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" showing data from two studies. Study 1 compares placebo (12%) to Gabapentin 3600 mg (29%). Study 2 compares placebo (14%) to Gabapentin 1800 mg (32%) and Gabapentin 2400 mg (34%). Statistical significance is indicated for gabapentin groups versus placebo.*

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Figure-4 (Figure4)

A scatter plot chart depicting responder rates in patients receiving Gabapentin as differences from placebo by daily dose and study. The x-axis represents daily dose in mg (600, 900, 1200, 1800), and the y-axis shows difference percentages from 2% to 22%. Three studies (a, b, c) are represented with distinct square markers on the plot for each dose.*

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Struc (Struct)

Chemical structure of gabapentin showing a cyclohexane ring attached to two side chains: one with an amine group (CH2NH2) and the other with a carboxylic 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.