Gabapentin
Product Images NDC 45865-498

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 45865-498). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medsource Pharmaceuticals, 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

Pdp (498 60)

Label for Gabapentin 400 mg capsules, generic for Neurontin, supplied in a quantity of 60 capsules. The label includes warnings about dizziness and drowsiness, advising to avoid alcohol. The lot number, NDC, manufacturer (Camber Pharmaceuticals), and directions for use with space to fill in dosage are also visible. The labeler is Medsource Pharmaceuticals.*

FDA Label Image

Figure3 (Figure3)

A bar chart titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing placebo (PBO) and Gabapentin (GBP) at different dosages in two studies. Study 1 shows 12% responders for placebo and 29% for GBP 3600 mg. Study 2 shows 14% responders for placebo, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance is indicated with p-values below 0.01 and 0.001.*

FDA Label Image

Figure4 (Figure4)

A scatter plot chart showing percentage difference versus daily dose in mg for Gabapentin across three studies (a, b, c). The x-axis indicates daily dose values from 600 to 1800 mg. The y-axis shows difference percentages up to 22%. Data points for each study are marked with different filled square symbols and letters a, b, and c, representing distinct study groups.*

FDA Label Image

Structure (Structure)

Chemical structure diagram of Gabapentin showing a cyclohexane ring attached to an aminoethyl and a carboxymethyl group.*

FDA Label Image

Study1 (Study1)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1' showing mean pain scores over an 8-week period. The x-axis represents weeks from baseline to week 8, and the y-axis represents mean pain scores ranging from 0 to 10. Two lines compare placebo and Gabapentin at 3600 mg/day, with a 4-week dose titration period followed by a 4-week fixed dose period.*

FDA Label Image

Study2 (Study2)

A line graph showing weekly mean pain scores over seven weeks, comparing placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day. The x-axis represents weeks, including a 3-week dose titration period and a 4-week fixed dose period. The y-axis shows mean pain scores. Gabapentin groups show decreasing pain scores over time compared to placebo.*

FDA Label Image

Table1 (Table1)

A data table titled 'TABLE 1. Gabapentin Dosage Based on Renal Function' showing dosage recommendations based on creatinine clearance levels and post-hemodialysis supplemental doses. The table includes ranges for total daily doses and specific dose regimens (TID, BID, QD) for different renal function categories. Additional notes define dosing adjustments, calculation of creatinine clearance, and a disclaimer on use in patients under 12 years.*

FDA Label Image

Table2 (Table2)

A data table showing risk by indication for antiepileptic drugs in pooled analysis. It lists incidence of events per 1000 patients for placebo and drug groups, plus relative risk and risk difference for epilepsy, psychiatric, other, and total categories.*

FDA Label Image

Table3a (Table3a)

A data table titled 'Treatment-Emergent Adverse Reaction Incidence in Controlled Trials in Postherpetic Neuralgia' showing reaction percentages for Gabapentin (N=336) and placebo (N=227). The table categorizes adverse reactions by body system and preferred term, including Body as a Whole, Digestive System, and Metabolic and Nutritional Disorders, listing specific reactions like asthenia, diarrhea, peripheral edema, and weight gain with their incidence rates for both groups.*

FDA Label Image

Table3b (Table3b)

A data table listing adverse events by system for Gabapentin, including nervous system symptoms like dizziness and somnolence with their reported counts, respiratory system event pharyngitis, and special senses effects such as amblyopia noted as blurred vision, conjunctivitis, diplopia, and otitis media.*

FDA Label Image

Table4a (Table4a)

Table presenting treatment-emergent adverse reaction incidence in controlled add-on trials for Gabapentin versus placebo in patients over 12 years old. It lists body system categories such as Body As A Whole, Cardiovascular, and Digestive System, with respective adverse reactions and their percentage occurrence in Gabapentin (N=543) and placebo (N=378) groups.*

FDA Label Image

Table4b (Table4b)

A data table listing adverse events reported in subjects taking Gabapentin, categorized by system organ class such as Nervous System, Respiratory System, Skin and Appendages, Urogenital System, and Special Senses. The table includes specific symptoms like somnolence, dizziness, ataxia, and diplopia with corresponding numerical values. Footnotes note additional context regarding antiepileptic drug therapy and descriptions of certain symptoms.*

FDA Label Image

Table5 (Table5)

A data table titled 'Treatment-Emergent Adverse Reaction Incidence in Pediatric Patients Age 3 to 12 Years in a Controlled Add-On Trial.' It compares percentages of adverse reactions reported in pediatric patients treated with Gabapentin (N=119) versus placebo (N=128), covering reactions in the body as a whole, digestive, nervous, and respiratory systems. Incidences of reactions such as viral infection, fever, somnolence, and bronchitis are listed.*

FDA Label Image

Table6 (Table6)

Data table titled 'TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing two studies with their duration, targeted gabapentin doses in mg/day, and patient counts receiving gabapentin or placebo. It includes notes on gabapentin dosing divided into three doses daily (TID).*

* 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.