Gabapentin Capsule
Product Images NDC 71335-1453

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 71335-1453). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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A data table titled 'Gabapentin Dosage Based on Renal Function' presenting dosage guidelines for Gabapentin based on varying levels of renal function measured by creatinine clearance (mL/min). It includes columns for total daily dose range (mg/day) and dose regimens (mg) for different frequencies (TID, BID, QD). The table also provides supplemental post-hemodialysis dosing and explanatory footnotes regarding dose adjustments for patients with reduced creatinine clearance and calculation of creatinine clearance using the Cockcroft and Gault equation.*

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A data table titled 'Risk by Indication for Antiepileptic Drugs in the Pooled Analysis.' It compares placebo patients and drug patients with events per 1,000 patients for indications including Epilepsy, Psychiatric, and Other. The table also shows relative risk and risk difference for drug patients versus placebo patients across these indications.*

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A table presenting adverse reactions in pooled placebo-controlled trials for Gabapentin 300 mg compared to placebo in postherpetic neuralgia. The table categorizes adverse reactions by system (e.g., body, digestive, nervous) and lists percentages of patients experiencing events like dizziness, somnolence, peripheral edema, and others for Gabapentin and placebo groups.*

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Table showing adverse reactions in pooled placebo-controlled add-on trials of Gabapentin versus placebo in epilepsy patients over 12 years of age. It lists various body systems and specific adverse reactions, with percentages of patients experiencing each reaction for Gabapentin (N=543) and placebo (N=378).*

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A data table titled 'TABLE 5. Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years.' It compares the percentage of adverse reactions reported in patients taking Gabapentin (N=119) versus Placebo (N=128). Categories include body as a whole, digestive system, nervous system, and respiratory system with specific reactions listed such as viral infection, fever, nausea, somnolence, and bronchitis.*

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Chemical structure of gabapentin showing a cyclohexyl ring attached to an amino group (CH2NH2) and a carboxymethyl group (CH2CO2H).*

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A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' listing two studies. It details study duration, gabapentin target dose in mg/day, patients receiving gabapentin, and patients receiving placebo. Study 1 lasted 8 weeks with a 3,600 mg/day dose for 113 patients on gabapentin and 116 on placebo. Study 2 lasted 7 weeks with doses of 1,800 and 2,400 mg/day for 223 gabapentin patients and 111 placebo patients. Total patients were 336 for gabapentin and 227 for placebo.*

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A line graph depicting mean pain score over baseline and 8 weeks comparing Gabapentin at 3600 mg/day versus placebo. The x-axis represents weeks, and the y-axis shows mean pain score from 1 to 9. The graph distinguishes between a 4-week dose titration period and a 4-week fixed dose period.*

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A line graph showing mean pain scores over a 7-week period comparing placebo and two dosages of gabapentin (1800 mg/day and 2400 mg/day). The x-axis represents weeks, with a 3-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores ranging from 0 to 10.*

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A bar graph titled 'Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint: Controlled PHN Studies' compares response rates in two studies. Study 1 shows 12% for placebo (PBO) and 29% for gabapentin 3600 mg (GBP 3600). Study 2 shows 14% for placebo, and 32% and 34% for gabapentin 1800 mg and 2400 mg, respectively. Statistical significance is noted with p-values less than 0.01 and 0.001.*

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A scatter plot showing the relationship between daily dose (mg) on the x-axis and difference (%) on the y-axis for three studies labeled a, b, and c. Study a is indicated by black squares, study b by light gray squares, and study c by white squares. Data points are shown at doses of 600 mg, 900 mg, 1200 mg, and 1800 mg with varying percentage differences for each study.*

FDA Label Image

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Label for Gabapentin Capsules, USP 300 mg by Bryant Ranch Prepack. The label displays the NDC 71335-1453-01, the dosage strength prominently in a red-bordered box, and indicates the package contains 30 capsules. Storage instructions and a caution about dizziness are also present alongside a barcode and labeler information.*

FDA Label Image

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Label for Gabapentin 300 mg capsule, packaged by Bryant Ranch Prepack, Burbank, CA. The label states the capsule is yellow and compares the product to Neurontin 300 mg capsules by InvaGen Pharmaceuticals, Inc. It indicates a package size of 30 capsules and includes storage instructions to keep at 20°-25°C (68°-77°F). The product is Rx only and has an NDC of 71335-1453-1.*

* 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.