Gabapentin Tablet, Film Coated
Product Images NDC 0904-6823

8 FDA label images from Major Pharmaceuticals · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 0904-6823). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Major Pharmaceuticals, 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

E6746052 Be65 4002 B833 4b2a140b92ef 00

E6746052 Be65 4002 B833 4b2a140b92ef 00
Gabapentin 800 mg film-coated tablets unit dose package label from Major Pharmaceuticals. The label shows NDC 0904-7108-61, contains 100 tablets, and includes handling instructions such as pharmacist dispensing with medication guide and storage recommendations. Distributed by Major Pharmaceuticals and Aurobindo Pharma USA.*
FDA Label Image

E6746052 Be65 4002 B833 4b2a140b92ef 01

E6746052 Be65 4002 B833 4b2a140b92ef 01
Label for Major Pharmaceuticals Gabapentin Tablets, USP 600 mg film-coated tablets, oral route. It is a unit dose package containing 100 tablets. The label includes NDC 0904-6823-61 and instructions to dispense with a medication guide. Storage and safety information, as well as distributor details, are provided on the label.*
FDA Label Image

Creatinine Clearance (Gabapentin Fig1)

Creatinine Clearance (Gabapentin Fig1)
An illustration showing the formula for calculating Creatinine Clearance (CLCr), incorporating age, weight, serum creatinine levels, and a gender adjustment factor for females.*
FDA Label Image

Figure 1. Weekly Mean Pain Scores (observed Cases In Itt Population): Study 1 (Gabapentin Fig2)

Figure 1. Weekly Mean Pain Scores (observed Cases In Itt Population): Study 1 (Gabapentin Fig2)
A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1' comparing mean pain scores over 8 weeks between placebo and Gabapentin 3600 mg/day groups. The x-axis shows weeks from Baseline to Week 8, and the y-axis shows mean pain score from 0 to 10. The chart distinguishes a 4-week dose titration period followed by a 4-week fixed dose period.*
FDA Label Image

Figure 2. Weekly Mean Pain Scores (observed Cases In Itt Population): Study 2 (Gabapentin Fig3)

Figure 2. Weekly Mean Pain Scores (observed Cases In Itt Population): Study 2 (Gabapentin Fig3)
Line graph showing weekly mean pain scores over seven weeks from a study with a 3-week dose titration period and 4-week fixed dose period. The graph compares placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day, depicting pain score changes from baseline to week 7.*
FDA Label Image

Figure 3. Proportion Of Responders (patients With ≥50% Reduction In Pain Score) At Endpoint: Controlled Phn Studies (Gabapentin Fig4)

Figure 3. Proportion Of Responders (patients With ≥50% Reduction In Pain Score) At Endpoint: Controlled Phn Studies (Gabapentin Fig4)
A bar graph titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies' comparing placebo (PBO) versus gabapentin (GBP) doses in two studies. 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, with statistical significance indicated.*
FDA Label Image

Figure 4. Responder Rate In Patients Receiving Gabapentin Expressed As A Difference From Placebo By Dose And Study: Adjunctive Therapy Studies In Patients ≥12 Years Of Age With Partial Seizures (Gabapentin Fig5)

Figure 4. Responder Rate In Patients Receiving Gabapentin Expressed As A Difference From Placebo By Dose And Study: Adjunctive Therapy Studies In Patients ≥12 Years Of Age With Partial Seizures (Gabapentin Fig5)
A scatter plot showing the responder rate difference (%) between Gabapentin and placebo by daily dose (mg) in adjunctive therapy studies for patients aged 12 years and older with partial seizures. The graph displays data points for three studies labeled a, b, and c, plotted against daily doses ranging roughly from 600 mg to 1800 mg.*
FDA Label Image

Chemical Structure (Gabapentin Str)

Chemical Structure (Gabapentin Str)
Chemical structure of Gabapentin, showing its cyclohexane ring bonded to both an amino group (CH2NH2) and a carboxylic acid group (CH2CO2H). This structural formula corresponds to the active ingredient Gabapentin.*

* 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.