Eslicarbazepine Acetate Tablet
Product Images NDC 60505-4660

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Eslicarbazepine Acetate (NDC 60505-4660). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

Figure1.jpg (Figure1)

A data table presenting fold changes with 90% confidence intervals for variables affecting eslicarbazepine exposure, including age, gender, hepatic impairment, and renal impairment. It shows recommendations regarding dose adjustments based on these factors, such as no dose adjustment for age ≥65 years and females, and dose reduction recommendations for moderate and severe renal impairment.*

FDA Label Image

Figure2.jpg (Figure2)

A horizontal forest plot showing fold changes and 90% confidence intervals for eslicarbazepine relative to reference when combined with various drugs including Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate. Recommendations related to dose adjustments are noted alongside specific drugs.*

FDA Label Image

Figure3a.jpg (Figure3)

A table showing fold change and 90% confidence intervals for various antiepileptic drugs (AEDs) when used with Eslicarbazepine Acetate. It lists drugs such as Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate, along with recommendations about dose adjustments or monitoring. The chart includes a horizontal scale indicating change of other drugs relative to reference and notes potential pharmacodynamic interactions.*

FDA Label Image

Figure3b.jpg (Figure3b)

A chart illustrating fold change and 90% confidence intervals for various drugs, categorized by non-AEDs, statins, oral contraceptives, and Warfarin. The x-axis shows change relative to a reference, while the table includes recommendations related to dosing adjustments and monitoring for drugs such as digoxin, metformin, simvastatin, rosuvastatin, ethinylestradiol, levonorgestrel, and Warfarin.*

FDA Label Image

Figure4.jpg (Figure4)

A Kaplan-Meier estimate chart showing exit rates (%) with 95% confidence intervals for Eslicarbazepine Acetate tablets at 1200 mg and 1600 mg doses. Data points from two studies are displayed with sample sizes, comparing these doses against historical controls.*

FDA Label Image

Figure5.jpg (Figure5)

A bar graph depicting the proportion of patients by percentage reduction in seizure frequency from baseline across three groups: Placebo (N=406), Eslicarbazepine Acetate Tablets 800 mg (N=375), and Eslicarbazepine Acetate Tablets 1200 mg (N=352). The x-axis shows categories of seizure frequency reduction from 'Worse' to '75 to 100%,' and the y-axis indicates the proportion of patients in percentage.*

FDA Label Image

Lbl200mg30.jpg (Lbl200mg30s)

Label for Eslicarbazepine Acetate Tablets 200 mg in a 30-tablet bottle. The label indicates once daily oral tablets manufactured by Apotex Corp., with storage instructions and a note to keep out of reach of children. The label includes NDC 60505-4658-3 and a barcode.*

FDA Label Image

Lbl400mg30.jpg (Lbl400mg30s)

Label for Eslicarbazepine Acetate Tablets 400 mg, oral tablets manufactured by Apotex Corp. The package contains 30 tablets with directions for daily use. Storage instructions specify controlled room temperature and emphasize keeping the container tightly closed and out of reach of children. It advises dispensing the enclosed Medication Guide to patients.*

FDA Label Image

Lbl600mg60.jpg (Lbl600mg60s)

Label for Eslicarbazepine Acetate Tablets 600 mg oral tablets by Apotex Corp. The label indicates a package of 60 tablets, with storage instructions between 20°C to 25°C and dispensing guidance. It includes a barcode and manufacturer information for Apotex Inc., Toronto, Ontario, and Apotex Corp., Weston, Florida.*

FDA Label Image

Lbl800mg30.jpg (Lbl800mg30s)

Label of Eslicarbazepine Acetate Tablets 800 mg by Apotex Corp. The oral tablet bottle contains 30 tablets labeled for once-daily use. Storage instructions specify temperature ranges, and the label includes a barcode, manufacturer and distributor information, and pharmacist dispensing instructions.*

FDA Label Image

Structure.jpg (Structure)

Chemical structure of Eslicarbazepine Acetate, showing its molecular framework with characteristic rings and functional groups.*

* 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.