Gabapentin
Product Images NDC 10544-185

6 FDA label images from Blenheim Pharmacal, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 10544-185). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Blenheim Pharmacal, 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

Bottle Label (10544 185 30 16714 661 02)

Bottle Label (10544 185 30   16714 661 02)
Label for Gabapentin Capsules USP 100 mg by Blenheim Pharmacal, Inc. The package contains 30 capsules and indicates prescription use only. Instructions note to store at controlled room temperature and to keep out of reach of children. The label includes barcode, NDC 10544-185-30, lot number, and manufacturing details.*
FDA Label Image

Figure 1. Weekly Mean Pain Scores (observed Cases In Itt Population): Study 1 (Gabapentin Fig1)

Figure 1. Weekly Mean Pain Scores (observed Cases In Itt Population): Study 1 (Gabapentin Fig1)
Line graph depicting mean pain score over an 8-week period comparing Gabapentin 3600 mg/day and placebo. The x-axis represents weeks including a 4-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 10. Gabapentin shows a decreasing pain score trend significantly lower than placebo, marked with statistical significance (p < 0.01).*
FDA Label Image

Figure 2. Weekly Mean Pain Scores (observed Cases In Itt Population): Study 2 (Gabapentin Fig2)

Figure 2.  Weekly Mean Pain Scores (observed Cases In Itt Population): Study 2 (Gabapentin Fig2)
Line graph showing mean pain scores over 7 weeks comparing placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day. The x-axis represents weeks from baseline through a 3-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores. Both Gabapentin doses demonstrate a marked reduction in pain score compared to placebo throughout the study.*
FDA Label Image

Figure 3. Proportion Of Responders (patients With ≥50% Reduction In Pain Score) At Endpoint: Controlled Phn Studies (Gabapentin Fig3)

Figure 3. Proportion Of Responders (patients With ≥50% Reduction In Pain Score) At Endpoint: Controlled Phn Studies (Gabapentin Fig3)
A bar chart showing the percentage of responders at endpoint in two studies comparing placebo (PBO) and Gabapentin (GBP) at different doses (1800 mg, 2400 mg, 3600 mg). Study 1 shows 12% for placebo and 29% for GBP 3600 mg. Study 2 shows 14% for placebo, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance is indicated by ** (p < 0.01) and *** (p < 0.001).*
FDA Label Image

Figure 4. Responder Rate In Patients Receiving Gabapentin Expressed As A Difference From Placebo By Dose And Study (Gabapentin Fig4)

Figure 4. Responder Rate In Patients Receiving Gabapentin Expressed As A Difference From Placebo By Dose And Study (Gabapentin Fig4)
A scatter plot chart comparing differences (%) against daily dose (mg) for Gabapentin in three studies labeled a, b, and c. The chart shows data points for doses ranging approximately from 600 to 1800 mg, with differences ranging roughly between 7% and 20%. Study a is represented by black squares, study b by gray squares, and study c by white squares.*
FDA Label Image

Chemical Structure (Gabapentin Str)

Chemical Structure (Gabapentin Str)
Chemical structure of gabapentin showing its molecular framework, including amine and carboxylic acid functional groups attached to a cyclohexane ring.*

* 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.