Gabapentin Tablet, Film Coated
Product Images NDC 65862-524

8 FDA label images from Aurobindo Pharma Limited · 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 65862-524). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

Product Images & Figures Index

FDA Label Image

Creatinine Clearance (Gabapentin Fig1)

Creatinine Clearance (Gabapentin Fig1)
An illustration showing the formula for calculating creatinine clearance (CLCr) which incorporates age, weight, serum creatinine level, and a factor for female patients. This formula is used to estimate kidney function.*
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 depicting weekly mean pain scores over eight weeks in a clinical study. The x-axis represents time in 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. Two groups are compared: Placebo (shown with open circles) and Gabapentin 3600 mg/day (shown with filled triangles). Pain scores decrease over time for the Gabapentin group, while scores remain relatively stable for the placebo group.*
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)
A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2' showing mean pain scores over 7 weeks, including a 3-week dose titration period and a 4-week fixed dose period. It compares placebo with gabapentin doses of 1800 mg/day and 2400 mg/day, plotting mean pain scores from baseline through 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)
Bar chart titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies.' It compares the percentage of responders between placebo (PBO) and gabapentin (GBP) at different dosages in two studies, showing higher response rates with gabapentin doses of 1800 mg to 3600 mg versus placebo.*
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 titled 'Responder Rate in Patients Receiving Gabapentin Expressed as Difference from Placebo by Dose and Study' showing percentage difference in responder rates across varying daily doses of gabapentin (600, 900, 1200, and 1800 mg). It includes three studies (a, b, c) represented by different symbols, illustrating dose-dependent effects in patients aged 12 years and older with partial seizures.*
FDA Label Image

Package Label-principal Display Panel (600 mg (100 Tablets Bottle))

Package Label-principal Display Panel (600 mg (100 Tablets Bottle))
Label for Gabapentin Tablets USP 600 mg film-coated tablets, distributed by Aurobindo Pharma USA, Inc. The label states the drug is Rx only and for 100 tablets per package. It includes storage instructions and a coding area for printing additional information. The label indicates the product is made in India by Aurobindo Pharma Limited.*
FDA Label Image

Package Label-principal Display Panel (800 mg (100 Tablets Bottle))

Package Label-principal Display Panel (800 mg (100 Tablets Bottle))
Label for Gabapentin Tablets, USP 800 mg film-coated tablets by Aurobindo Pharma Limited. The package contains 100 tablets and is marked Rx only. Storage instructions recommend 20° to 25°C. Distributed by Aurobindo Pharma USA, Inc., made in India. Includes a note for pharmacists to dispense the Medication Guide separately.*
FDA Label Image

Chemical Structure (Gabapentin Str)

Chemical Structure (Gabapentin Str)
Chemical structure of gabapentin, depicting its cyclohexane ring bonded to a molecule containing an amino group (CH2NH2) and a carboxylic acid 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.