Gabapentin
Product Images NDC 67296-1710

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Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 67296-1710). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Redpharm Drug, 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

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This is a dosage table for Gabapentin based on renal function. The table shows the recommended doses of Gabapentin for patients with different creatinine clearance levels. It includes the total daily dose range for patients, divided by the frequency of administration (TID, BID, or QD), and a supplemental post-hemodialysis dose for patients on hemodialysis. The table also includes instructions for reducing the daily dosage for patients with creatinine clearance less than 15mL/min. Additionally, the table notes that creatinine clearance can be estimated using the Cockcroft and Gault equation.*
FDA Label Image

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This is a table presenting risk data for antiepileptic drugs in patients with epilepsy, psychiatric disorders, and other indications. It compares the number of patients experiencing events (presumably side-effects) per 1,000 patients between those taking a placebo and those taking a drug. It also shows the relative risk of events in patients taking the drug compared to those taking a placebo, as well as the additional number of drug patients with events per 1,000 patients.*
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This is a table showing adverse reactions in pooled placebo-controlled trials in Postherpetic Neuralgia. The table provides data on the percentage of patients experiencing different types of adverse reactions after being administered Gabapentin and Placebo. The adverse reactions are categorized into different body systems, such as the nervous system, digestive system, and respiratory system. The adverse reactions observed in Gabapentin group include Asthenia, Infection, Diarrhea, and Dizziness, among others, whereas the Placebo group experienced mainly Asthenia, Diarrhea, and Dry mouth. Blurred vision is reported as an adverse reaction under Special Senses observation.*
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This is a table that presents the adverse reactions in pooled placebo-controlled add-on trials in epilepsy patients over 12 years of age who took Gabapentin or a Placebo drug. The table shows the percentage of patients who experienced each adverse reaction for each drug. Adverse reactions are grouped by body system, including body as a whole, cardiovascular, digestive system, nervous system, respiratory system, skin and appendages, urogenital system, and special senses. The adverse reactions for Gabapentin included fatigue, increased weight, back pain, peripheral edema, vasodilation, dyspepsia, dry mouth or throat, constipation, dental abnormalities, somnolence, dizziness, ataxia, nystagmus, tremor, dysarthria, amnesia, depression, abnormal thinking, abnormal coordination, pharyngitis, coughing, abrasion, impotence, diplopia, and amblyopia. The adverse reactions for the placebo group were also presented. Amblyopia was often described as blurred vision.*
FDA Label Image

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This is a table showing the adverse reactions of a placebo-controlled add-on trial in pediatric epilepsy patients aged 3 to 12 years who received Gabapentin versus Placebo. The table includes the number of patients and the percentage of adverse reactions experienced during the trial, including body aches, fever, increased weight, fatigue, nausea and/or vomiting, somnolence, hostility, emotional lability, dizziness, hyperkinesia, bronchitis, and respiratory infection. Note that background antiepileptic drug therapy was also used.*
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The text describes a table showing the duration of controlled PHN (Postherpetic neuralgia) studies and the dosages administered to patients. Two studies were conducted with different target doses of Gabapentin and a total of 563 patients participated, with 336 receiving Gabapentin and 227 receiving placebo. It is also stated that Gabapentin was given in three divided doses (TID).*
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This appears to be a figure from a medical study related to Postherpetic neuralgia (PHN). The figure represents the proportion of patients who responded positively to treatment (>50% reduction in pain score) in two controlled studies. The study names and some percentages are mentioned, but further information is not available.*
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FDA Label Image

Label (Gabapentin 300 1710)

Label (Gabapentin 300 1710)
This is a description for a medication called Gabapentin, in the form of 300mg capsules. The medication is only available by prescription and comes in a bottle of 60 capsules with lot number 901545X1 and expiry date of 03/21. The medication is used for adults and the dosage can be found in the package insert. The medication should be stored in a controlled room temperature between 20.25 C (68-77 F). The manufacturer is Invagen Pharmaceuticals Inc located in Hauppauge, NY while the distributor is Redpharm Drug located in Eden Prairie, MN.*

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