Gabapentin
Product Images NDC 50436-1263

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Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 50436-1263). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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

Fig1-2-3 (Fig123)

Fig1-2-3 (Fig123)
The text describes the results of two controlled PHN studies, and presents data on the weekly mean pain scores observed in ITT population as well as the proportion of responders, patients who reported at least a 50% improvement in endpoint pain score compared with baseline. Two figures (Figure 1 and Figure 2) show the weekly mean pain scores over time for the two studies respectively, and a third figure (Figure 3) presents the proportion of responders for each study with different doses of drugs.*
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Fig4 (Fig4)

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Table1 (Img1)

Table1 (Img1)
This is a dosage table for Gabapentin based on renal function, which includes different doses and frequencies of medication intake. It provides the recommended dosage for patients with different levels of renal function, measured in mL/min. The table also includes supplemental post-hemodialysis doses for patients on hemodialysis. For patients with creatinine clearance <15 mL/min, the daily dosage should be adjusted in proportion to their creatinine clearance. The use of gabapentin for pediatric patients below 12 years of age with renal impairment is not studied.*
FDA Label Image

Label Image (Lbl504361263)

Label Image (Lbl504361263)
This is a medication warning label for Gabapentin, 100 mg, 30 capsules manufactured by "FORYOO0X". The lot number is 000K and was packaged by Unit Dose Services LLC with an expiration date of XXOXKXX on lot number XXOUXXX. The NDC number is 50436-1263-1 and warns to discontinue use if any adverse side effects occur.*
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Structure (Struct)

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Table-2 (Tab2)

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Tab3 (Tab3)

Tab3 (Tab3)
This is a table showing the adverse reactions observed in pooled placebo-controlled trials in postherpetic neuralgia patients treated with gabapentin compared to placebo. The adverse reactions are listed by body system, and the percentage of patients experiencing the reaction is given for each treatment group. The adverse reactions reported for gabapentin-treated patients include Asthenia, Infection, Accidental injury, Diarrhea, Dry mouth, Constipation, Nausea, Vomiting, Peripheral edema, Weight gain, Hyperglycemia, Dizziness, Somnolence, Abnormal thinking, Abnormal gait, Incoordination, Pharyngitis, Amblyopia, Conjunctivitis, Diplopia, and Otitis media. Blurred vision was reported as an adverse reaction to gabapentin.*
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Tab4 (Tab4)

Tab4 (Tab4)
This is a table showing the adverse reactions reported in pooled placebo-controlled add-on trials for epilepsy patients over 12 years old who were given Gabapentin. The table lists the adverse reactions experienced by the patients, and the percentage of patients who experienced them. The adverse reactions are categorized by body system, including the body as a whole, cardiovascular system, digestive system, nervous system, respiratory system, skin and appendages, urogenital system, and special senses. The table also includes a note about the background antiepileptic drug therapy and a description of amblyopia as blurred vision.*
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Tab5 (Tab5)

Tab5 (Tab5)
The table presents the results of a placebo-controlled add-on trial for Gabapentin® in pediatric epilepsy patients between 3 to 12 years old. The table shows the percentage of patients who experienced adverse reactions to the treatment and to the placebo, including viral infection, fever, increased weight, fatigue, nausea, vomiting, somnolence, hostility, emotional lability, dizziness, hyperkinesia, bronchitis, and respiratory infections.*
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Table-6 (Tab6)

Table-6 (Tab6)
This is a table showing the dosages, duration, and number of patients in two controlled PHN studies performed with Gabapentin. The first study lasted 8 weeks and had a target dose of 3600 mg/day. The second study lasted 7 weeks and had target doses of 1800 mg/day and 2400 mg/day, given in 3 divided doses (TID). The total number of patients receiving Gabapentin was 336, while the number receiving placebo was 227.*

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