Gabapentin
Product Images NDC 53217-241

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 53217-241). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals Llc, 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

Image (Gabapentin Usp 100 mg 1)

Table showing gabapentin dosage based on renal function, detailing total daily dose ranges and dose regimens according to creatinine clearance levels. It includes special instructions for patients on hemodialysis with supplemental post-hemodialysis doses and clarifications on dosing frequency abbreviations (TID, BID, QD).*

FDA Label Image

Image (Gabapentin Usp 100 mg 10)

A line graph depicting mean pain scores over a 7-week period for placebo and two gabapentin dosages (1800 mg/day and 2400 mg/day). The x-axis represents weeks including a 3-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 10. Gabapentin groups show a decrease in pain scores compared to placebo.*

FDA Label Image

Image (Gabapentin Usp 100 mg 11)

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 across two studies. Study 1 shows 12% response for PBO and 29% for GBP 3600. Study 2 shows 14% response for PBO, 32% for GBP 1800, and 34% for GBP 2400. Statistical significance is indicated with p-values <0.01 and <0.001.*

FDA Label Image

Image (Gabapentin Usp 100 mg 12)

A scatter plot comparing the percentage difference against daily dose (mg) at 600, 900, 1200, and 1800 mg for three studies labeled a, b, and c. Study a is marked with black squares, study b with gray squares, and study c with white squares. The y-axis denotes difference percentage ranging approximately from 2% to 22%.*

FDA Label Image

Image Description (Gabapentin Usp 100 mg 13)

GABAPENTIN, USP 100mg capsule label showing a bottle of 15 capsules. The label states it is generic for Neurontin, packaged by Aidarex Pharmaceuticals LLC, with manufacturing details listing Invagen Pharmaceuticals, Inc. The capsule is described as white and oblong with 100mg IG321 on one side.*

FDA Label Image

Image (Gabapentin Usp 100 mg 2)

An illustration showing the formula for estimating creatinine clearance (CLCr). The formula includes variables for age in years, weight in kilograms, serum creatinine in mg/dL, and a multiplier of 0.85 for female patients.*

FDA Label Image

Image (Gabapentin Usp 100 mg 3)

A table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' presenting data on events per 1000 patients for placebo and drug groups, relative risk, and risk difference across epilepsy, psychiatric, other indications, and total categories.*

FDA Label Image

Image (Gabapentin Usp 100 mg 4)

A data table titled 'TABLE 3. Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing the incidence percentages of various adverse reactions between Gabapentin (N=336) and placebo (N=227). The table categorizes reactions by body system, including Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, listing specific reactions and their corresponding percentages for both groups.*

FDA Label Image

Image (Gabapentin Usp 100 mg 5)

A data table titled 'TABLE 4. Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epilepsy Patients >12 years of age.' It lists various adverse reactions categorized by body system comparing the incidence percentages in patients treated with Gabapentin (N=543) versus placebo (N=378). Categories include Body As A Whole, Cardiovascular, Digestive System, Nervous System, Respiratory System, Skin and Appendages, Urogenital System, and Special Senses. The table shows higher percentages of several reactions in the Gabapentin group compared to placebo.*

FDA Label Image

Image (Gabapentin Usp 100 mg 6)

A data table titled 'TABLE 5. Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years' showing percentages of various adverse reactions in Gabapentin (N=119) versus Placebo (N=128) groups. Reactions are categorized by body system, including body as a whole, digestive, nervous, and respiratory systems, with specific adverse reactions and their corresponding incidence percentages for each group.*

FDA Label Image

Image (Gabapentin Usp 100 mg 7)

Chemical structure of gabapentin, depicted as a molecular diagram showing its cyclohexane ring bonded to an aminomethyl group and a carboxymethyl group.*

FDA Label Image

Image (Gabapentin Usp 100 mg 8)

A data table titled 'TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients' summarizing two studies with durations of 8 weeks and 7 weeks. It lists gabapentin target doses of 3600 mg/day for study 1, and 1800 or 2400 mg/day for study 2, along with the number of patients receiving gabapentin and placebo in each study and in total.*

FDA Label Image

Image (Gabapentin Usp 100 mg 9)

A line graph depicting mean pain score over an 8-week period comparing placebo and Gabapentin 3600 mg/day. The x-axis represents weeks, starting at baseline and continuing through 8 weeks, with a division between a 4-week dose titration period and a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 10. Gabapentin shows a decreasing pain score trend, while placebo remains relatively stable.*

* 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.