Gabapentin Capsule
Product Images NDC 70518-4261

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 70518-4261). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack 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

Remedy_label (Remedy Label)

Label for Gabapentin 100 mg capsules by RemedyRepack Inc. The label indicates a quantity of 30 tablets and includes an NDC number 70518-4261-00. The medication is marked RX only and is repackaged by RemedyRepack Inc., Indiana, PA. Manufacturer is Cipla Ltd., Kurkumbh, India. Storage instructions and barcode are also visible.*

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Table titled 'Gabapentin Dosage Based on Renal Function' presenting gabapentin dosing regimens categorized by renal function measured as creatinine clearance (mL/min). The table lists total daily dose ranges (mg/day) and specific dose regimens (mg) for different levels of clearance, including post-hemodialysis supplemental doses. Additional notes explain dosing adjustments and provide the Cockcroft-Gault equation for estimating creatinine clearance.*

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A data table titled 'Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' comparing event rates per 1,000 patients for placebo and drug groups across indications: Epilepsy, Psychiatric, Other, and Total. It includes columns for placebo events, drug events, relative risk, and risk difference for additional drug events per 1,000 patients.*

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A table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing adverse reaction percentages between Gabapentin (N=336) and placebo (N=227). It lists reactions under categories such as Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses with corresponding percentages for each group.*

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A table presenting adverse reactions from pooled placebo-controlled add-on trials in epilepsy patients over 12 years old, comparing Gabapentin (N=543) versus placebo (N=378). Reactions are categorized by body systems (e.g., nervous, digestive, respiratory) with corresponding percentages for each group, highlighting common and rare side effects.*

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Table summarizing adverse reactions in a placebo-controlled add-on trial involving pediatric epilepsy patients aged 3 to 12 years. It compares the percentage of patients experiencing various adverse reactions in the Gabapentin group (N=119) versus the Placebo group (N=128), categorized by body system including viral infection, fever, digestive symptoms, nervous system effects, and respiratory system effects.*

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Chemical structure of gabapentin showing a cyclohexyl ring attached to an amino group and a carboxymethyl group, representing the molecular arrangement of the active ingredient gabapentin.*

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A data table titled 'TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing study durations, gabapentin target doses in mg/day, and numbers of patients receiving gabapentin or placebo across two studies. Study 1 lasted 8 weeks with a 3,600 mg/day dose, and Study 2 lasted 7 weeks with 1,800 and 2,400 mg/day doses. Patient totals are 336 for gabapentin and 227 for placebo.*

FDA Label Image

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A line graph comparing mean pain scores over an 8-week period between placebo and gabapentin 3600 mg/day groups. The x-axis represents weeks including a 4-week dose titration period and a 4-week fixed dose period. The y-axis shows mean pain scores ranging from 0 to 10.*

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A line graph depicting mean pain scores over a 7-week period for three groups: placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day. The x-axis shows time in weeks from baseline through a 3-week dose titration and a 4-week fixed dose period, while the y-axis shows mean pain scores ranging from 0 to 10. Gabapentin groups show a decreasing trend in pain scores compared to placebo.*

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A bar chart titled 'Figure 3. Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing placebo (PBO) and gabapentin (GBP) at different dosages across two studies. Study 1 shows 12% response for placebo and 29% for GBP 3600. Study 2 shows 14% for placebo, 32% for GBP 1800, and 34% for GBP 2400, with significance levels indicated as p < 0.01 and p < 0.001.*

FDA Label Image

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A scatter plot graph depicting percentage difference on the y-axis versus daily gabapentin dose in milligrams on the x-axis, with data points representing three different studies labeled as Study a, Study b, and Study c. The graph shows the relationship between increasing gabapentin daily dose (600 to 1800 mg) and difference percentage across the three studies.*

* 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.