Gabapentin Capsule
Product Images NDC 63187-909

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Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 63187-909). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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

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This text provides a table showing the recommended dosage of Gabapentin based on a patient's renal function measured by creatinine clearance. The table includes dosage range and regimen recommendations for patients with varying levels of renal function. It also specifies a supplemental post-hemodialysis dose for patients undergoing hemodialysis. Dosage frequency abbreviations are explained, and a dosage reduction recommendation is given for patients with creatinine clearance less than 15 mL/min.*
FDA Label Image

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FDA Label Image

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This text presents a table indicating the risk of antiepileptic drugs in comparison with placebo in patients with different indications such as epilepsy, psychiatric disorders, and others. The table shows the incidence of events per 1000 patients in both placebo and drug patients, as well as the relative risk and risk difference between the two groups.*
FDA Label Image

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This is a table showing the percentage of adverse reactions in pooled placebo-controlled trials in postherpetic neuralgia for Gabapentin and Placebo. The table displays the number of occurrences for each reaction categorized by body part/system, such as the digestive or nervous system. Some of the common adverse reactions for Gabapentin are Asthenia, Infection, and Diarrhea, while for the placebo group Dizziness, Somnolence, and Pharyngitis were more common. Blurred vision is noted as "Reported as blured vision."*
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The table shows the adverse reactions reported in placebo-controlled trials of Gabapentin in epilepsy patients over 12 years old. The table compares the incidence of adverse reactions between Gabapentin and the placebo. The adverse reactions are categorized by body system, and the percentage of patients reporting each reaction is provided. The adverse reactions reported in the Gabapentin group include somnolence, dizziness, and dyspepsia among others. Amblyopia and vasodilation were reported more frequently in the Gabapentin group than in the placebo group. Amblyopia is a condition that causes blurred vision.*
FDA Label Image

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The table shows the adverse reactions of Gabapentin compared to Placebo in a controlled trial for pediatric epilepsy patients aged 3 to 12 years. The study included 110 participants in the Gabapentin group and 128 participants in the Placebo group. The adverse reactions reported for Gabapentin were Body Asthenia, Fever, Increased Weight, Fatigue, Nausea and/or Vomiting, Somnolence, Hostility, Emotional Lability, Dizziness, Hyperkinesia, Bronchitis, and Respiratory Infection. The adverse reactions reported for Placebo were Body Asthenia, Viral Infection, Fever, Digestive System, Nausea and/or Vomiting, Nervous System, Somnolence, Hostility, Emotional Lability, Dizziness, Hyperkinesia, and Respiratory Infection. Note that patients were also receiving other antiepileptic drug therapy.*
FDA Label Image

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This text is a table showing the details of Controlled PHN Studies. The table includes information about the duration, dosages, and the number of patients involved in each study who received Gabapentin and Placebo. The target dose of Gabapentin and the number of times it was given per day is also mentioned.*
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The text is a part of a figure showing the proportion of patients with greater than 50% reduction in pain score in controlled PHN studies. Two studies are mentioned, but the proportion of responders is only given for Study 2, which is 34%. The remaining text contains some statistical significance measures. There are also some values mentioned: GEP 3600, GBP 1800, and GBP 2400. The context of these values cannot be determined from the text provided.*
FDA Label Image

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63187-909-30 (D3fd11fe 4d3f 4002 8f9e 42cc12b4252d 15)

63187-909-30 (D3fd11fe 4d3f 4002 8f9e 42cc12b4252d 15)
This is a description of a gabapentin medication produced by InvaGen Pharmaceuticals, Inc. It is a hard gelatin capsule size "0" with an orange opaque cap and body that is imprinted with "400mg" and "1G323". It contains 400mg of USP gabapentin and is dispensed in packages of 90 capsules with lot number "00000". The medication guide attached to the packaging should be dispensed along with it. The medication is to be stored between 20°C-25°C and should be kept out of reach of children. The medication is packaged for Proficient Rx LP.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.