Gabapentin
Product Images NDC 67296-1721

12 FDA label images from Redpharm Drug, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 67296-1721). 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 data table titled "TABLE 1. Gabapentin Dosage Based on Renal Function" provides dosage recommendations based on creatinine clearance levels (mL/min), total daily dose ranges (mg/day), and dose regimens (mg) for gabapentin. It includes additional post-hemodialysis supplemental dose guidelines in milligrams (mg). The table explains dosing frequency abbreviations (TID, BID, QD) and notes for patients with renal impairment and hemodialysis. A formula for estimating creatinine clearance (CLCr) using age, weight, serum creatinine, and adjustment for females is also presented.*
FDA Label Image

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A data table titled 'Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' showing event incidence rates per 1,000 patients among placebo and drug groups for epilepsy, psychiatric, and other indications. It includes columns for relative risk and risk difference with values reported for each indication and totals.*
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A data table presenting adverse reactions reported in pooled placebo-controlled trials for postherpetic neuralgia. It compares percentages of side effects between Gabapentin (N=336) and placebo (N=227) groups across various categories including body as a whole, digestive system, metabolic and nutritional disorders, nervous system, respiratory system, and special senses.*
FDA Label Image

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Data table titled 'Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epilepsy Patients >12 years of age' comparing adverse reactions between Gabapentin (N=543) and Placebo (N=378). The table lists various body systems and corresponding percentages of patients experiencing specific adverse reactions such as fatigue, somnolence, dizziness, and others, with higher percentages generally noted in the Gabapentin group.*
FDA Label Image

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A data table showing adverse reactions in a placebo-controlled add-on trial of gabapentin in pediatric epilepsy patients aged 3 to 12 years. The table compares the percentage of patients experiencing various side effects in the gabapentin group (N=119) versus the placebo group (N=128), across body systems such as body as a whole, digestive, nervous, and respiratory systems.*
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Chemical structure of gabapentin showing a cyclohexane ring attached to an aminomethyl group and an acetic acid moiety.*
FDA Label Image

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Table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing two studies with durations of 8 and 7 weeks. It lists target Gabapentin doses (3600 mg/day for study 1, 1800 and 2400 mg/day for study 2), and numbers of patients receiving Gabapentin and placebo for each study, totaling 336 and 227 patients respectively. A footnote notes dosing was given in 3 divided doses (TID).*
FDA Label Image

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A line graph showing mean pain scores over 8 weeks for two groups: placebo and gabapentin 3600 mg/day. The x-axis represents time in weeks, starting at baseline. The y-axis shows mean pain score values. The graph distinguishes a 4-week dose titration period followed by a 4-week fixed dose period, with pain scores decreasing in the gabapentin group compared to placebo.*
FDA Label Image

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A line graph depicting mean pain scores over seven weeks for three groups: placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day. The graph shows a 3-week dose titration period followed by a 4-week fixed dose period, illustrating changes in pain scores across the timeline.*
FDA Label Image

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A bar chart titled "Figure 3. Proportion of Responders (patients with 6 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% for placebo and 29% for GBP 3600. Study 2 shows 14% for placebo and 32% and 34% for GBP 1800 and 2400 respectively, with significance levels indicated for GBP groups.*
FDA Label Image

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A scatter plot comparing difference percentages against daily doses in milligrams (mg) for three studies labeled a, b, and c. The x-axis shows daily dose values 600, 900, 1200, and 1800 mg, while the y-axis measures difference percentages up to 22%. Different symbols represent data points for each study.*
FDA Label Image

Label (Gabapentin 100 1721)

Label (Gabapentin 100 1721)
Label of Gabapentin 100 mg capsules, packaged in a bottle of 30 capsules. The label includes the NDC 67296-1721-3 and states Rx only. The manufacturer is Invager Pharmaceuticals Inc, Hauppauge, NY, with distribution by RedPharm Drug, Eden Prairie, MN. The lot number is 901936X1, and expiration is 04/21. Storage instructions note controlled room temperature 20-25°C (68-77°F).*

* 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.