Gabapentin Solution
Product Images NDC 44523-120

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 44523-120). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biocomp Pharma, 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.

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Figure 1 (Figure 1)

A line graph depicting the mean pain score over an 8-week period comparing placebo and Gabapentin 3600 mg/day. The x-axis represents weeks with a 4-week dose titration period followed by a 4-week fixed dose period, and the y-axis shows the mean pain score on a scale from 0 to 10. The graph shows a decline in pain score for Gabapentin relative to placebo.*

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Label (Figure 2)

A line graph showing mean pain score over 7 weeks for placebo and gabapentin dosed at 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. Gabapentin groups show a decrease in mean pain scores compared to placebo over time.*

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Label (Figure 3)

A bar graph titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies' displaying percentage responders for placebo (PBO) and Gabapentin (GBP) at various doses across two studies. Study 1 compares PBO (12%) and GBP 3600 mg (29%). Study 2 compares PBO (14%), GBP 1800 mg (32%), and GBP 2400 mg (34%). Statistical significance levels p < 0.01 and p < 0.001 are noted.*

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Label (Formula 1)

This image shows a formula for calculating creatinine clearance (CLCr) based on age, weight, serum creatinine, and a correction factor for female patients. It is likely part of clinical or dosing information related to Gabapentin 250 mg/5 mL oral solution.*

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Label (Table 1)

A dosing table for gabapentin oral solution showing dose regimens based on renal function clearance (mL/min) and total daily dose range (mg/day). It includes dose frequencies such as TID, BID, and QD for various renal clearance categories, plus a post-hemodialysis supplemental dosing section with mg amounts.*

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Label (Table 3)

Table presenting percentages of various adverse events reported in patients taking Gabapentin versus placebo. Categories include Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, with corresponding percentages for each event in Gabapentin (N=336) and placebo (N=227) groups.*

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Label (Table 4)

A data table comparing the incidence percentages of adverse events between Gabapentin and placebo groups across various body systems including nervous, digestive, cardiovascular, respiratory, skin, urogenital systems, and special senses. It lists specific symptoms such as fatigue, somnolence, dizziness, and diplopia among others, with corresponding percentages for each group.*

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Label (Table 5)

A data table comparing adverse events reported in a clinical study of Gabapentin versus placebo. The table lists categories such as Body As A Whole, Digestive System, Nervous System, and Respiratory System, with specific events like viral infection, fever, somnolence, hostility, and bronchitis, showing percentages for Gabapentin (N=119) and placebo (N=128) groups.*

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Chemical Structure (Image 02)

Chemical structure of Gabapentin, showing a cyclohexane ring bonded to an amino group (CH2NH2) and a carboxylic acid group (CH2CO2H).*

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Figure 4 (Image 06)

A scatter plot chart displaying percentage difference on the y-axis versus daily dose in milligrams on the x-axis, comparing three studies labeled 'STUDY a,' 'STUDY b,' and 'STUDY c.' Data points show varying percentage differences across daily doses of 600, 900, 1200, and 1800 mg.*

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Label (Label)

Label for Gabapentin Oral Solution 250 mg/5 mL (50 mg/mL) by BioComp Pharma, Inc. The label includes the NDC number 44523-120-16, states it is Rx Only, and indicates the container holds 470 mL. It advises pharmacists to provide a medication guide to patients and notes storage instructions to refrigerate at 2°C to 8°C (36°F to 46°F).*

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Label (Logo 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.