Gabapentin Capsule
Product Images NDC 85534-0003

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 85534-0003). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hawaii Repack, 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

Figure 1 (Image 01)

A line graph showing mean pain score over an 8-week period comparing placebo and Gabapentin 3600 mg/day. The x-axis represents weeks from baseline to week 8, and the y-axis shows mean pain scores from 0 to 10. The graph indicates a 4-week dose titration period followed by a 4-week fixed dose period.*

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Figure 2 (Image 02)

Line graph showing mean pain scores over 7 weeks comparing placebo and gabapentin at daily doses of 1800 mg and 2400 mg. The timeline includes a 3-week dose titration period followed by a 4-week fixed dose period. Pain scores decrease over time with gabapentin compared to placebo.*

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Figure 3 (Image 03)

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 various doses across two studies. The y-axis shows percentage responders from 0% to 100%, with GBP showing higher response rates (29%, 32%, 34%) than placebo (12%, 14%) in studies 1 and 2, respectively, indicating statistical significance at p < 0.01 and p < 0.001 levels.*

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Image-04 (Image 04)

A formula for calculating creatinine clearance (CLCr) is shown. It involves age in years, weight in kilograms, and serum creatinine in mg/dL, with a multiplier of 0.85 applied for female patients. The formula is presented in a mathematical expression format.*

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Gabapentin Structural Formula (Image 05)

Chemical structure of Gabapentin, showing a cyclohexane ring bonded to aminomethyl and acetic acid functional groups.*

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Image-09 (Image 09)

A scatter plot comparing the percentage difference versus daily dose (mg) for Gabapentin across three studies labeled a, b, and c. The daily doses shown are 600 mg, 900 mg, 1200 mg, and 1800 mg, with each study represented by distinct square markers. The y-axis shows the percentage difference ranging from 2 to 22%.*

FDA Label Image

100 (Label 100mg)

Labels for Gabapentin Capsules USP 100 mg, distributed by Hawaii Repack, Inc., showing quantities of 30, 60, 90, and 120 capsules. Each label includes an NDC, manufacturer information (ScieGen Pharmaceuticals, Inc.), and a QR code. The capsules are described as white to off-white in color.*

FDA Label Image

300 (Label 300mg)

Four packaging labels for Gabapentin Capsules, USP 300 mg, distributed by Hawaii Repack, Inc. Each label shows varying quantities: 30, 60, 90, and 120 capsules. Manufactured by ScieGen Pharmaceuticals, Inc., the labels include NDC numbers, description of capsule color as yellow opaque body and cap, lot and expiry fields, and storage instructions at controlled room temperature. Each label includes a barcode and QR code with identification details.*

FDA Label Image

400 (Label 400mg)

Four separate pharmacy labels for Gabapentin Capsules USP 400 mg distributed by Hawaii Repack, Inc. Each label lists a distinct package quantity: 30, 60, 90, and 120 capsules. The labeler address is 677 Ala Moana Blvd, Suite 700, Honolulu, HI 96813. Each includes barcodes, manufacturer information (SciGen Pharmaceuticals, Inc.), and storage instructions.*

* 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.