Gabapentin
Product Images NDC 43353-190

7 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 43353-190). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, 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 800mg (43353 190)

Bottle Label 800mg (43353 190)
Gabapentin 800 mg 270 tablets label by Aphena Pharma Solutions - Tennessee, LLC. The label shows the product name, strength, dosage form, tablet count, and includes storage instructions and manufacturer information. It also has barcodes and the prescription-only designation.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Gabapentin-fig01 (Gabapentin Fig01)

Gabapentin-fig01 (Gabapentin Fig01)
Line graph showing weekly mean pain scores over 8 weeks comparing placebo and Gabapentin 3600 mg/day. The x-axis represents weeks from baseline to week 8, divided into a 4-week dose titration period and a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 10. Gabapentin shows a consistent decrease in pain scores over time compared to placebo, with statistically significant differences indicated at multiple points (p < 0.01).*
FDA Label Image

Gabapentin-fig02 (Gabapentin Fig02)

Gabapentin-fig02 (Gabapentin Fig02)
A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2' showing mean pain scores over 7 weeks. The graph compares placebo with Gabapentin dosed at 1800 mg/day and 2400 mg/day. Two periods are indicated: a 3-week dose titration and a 4-week fixed dose. Gabapentin groups show consistently lower mean pain scores compared to placebo throughout the study.*
FDA Label Image

Gabapentin-fig03 (Gabapentin Fig03)

Gabapentin-fig03 (Gabapentin Fig03)
A bar chart showing the percentage of responders with at least 50% reduction in pain score at endpoint in controlled PHN studies. The chart compares placebo (PBO) and gabapentin (GBP) dosages across two studies: Study 1 shows 12% response for PBO and 29% for GBP 3600 mg; Study 2 shows 14% for PBO, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance markers indicate p values below 0.01 and 0.001.*
FDA Label Image

Gabapentin-fig04 (Gabapentin Fig04)

Gabapentin-fig04 (Gabapentin Fig04)
A scatter plot titled 'Responder Rate in Patients Receiving Gabapentin Expressed as a Difference from Placebo by Dose and Study.' The graph shows the difference in responder rate (%) on the y-axis and daily dose (mg) on the x-axis for three studies labeled a, b, and c. Data points for studies a, b, and c are represented with different squares at doses 600, 900, 1200, and 1800 mg, indicating variation in responder rates across different doses and studies in patients 12 years and older with partial seizures.*
FDA Label Image

Gabapentin-structure (Gabapentin Structure)

Gabapentin-structure (Gabapentin Structure)
Chemical structure of gabapentin, depicting its cyclohexane ring bonded to an amino group (CH2NH2) and a carboxyl group (CH2CO2H).*

* 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.