Eslicarbazepine Acetate Tablet
Product Images NDC 67877-588

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Eslicarbazepine Acetate (NDC 67877-588). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ascend Laboratories, 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

Eslicarbazepine-200mg-30-tablet (Eslicarbazepine 200mg 30 Tablets)

Label for Eslicarbazepine Acetate Tablets, 200 mg strength, oral tablet dosage form. The label includes directions for use as once daily, storage instructions, and safety warnings. It states manufacturing by Alkem Laboratories Ltd. and distribution by Ascend Laboratories, LLC. The package contains 30 tablets and is marked Rx only.*

FDA Label Image

Eslicarbazepine-400mg-30-tablet (Eslicarbazepine 400mg 30 Tablets)

Label for Eslicarbazepine Acetate Tablets 400 mg by Ascend Laboratories, LLC. The label shows dosage strength, directions as once daily, and package size of 30 tablets. Includes storage instructions and manufacturer details of Alkem Laboratories, Ltd., India, with distribution by Ascend Laboratories in New Jersey. Contains barcode and prescription-only notices.*

FDA Label Image

Eslicarbazepine-600mg-60-tablets (Eslicarbazepine 600mg 60 Tablets)

Label for Eslicarbazepine Acetate Tablets, 600 mg oral tablets. The label states each tablet contains 600 mg eslicarbazepine acetate, with a dosing instruction to see the package insert. It includes storage instructions and warnings to keep out of reach of children. The label shows a 60-tablet count. The labeler is Ascend Laboratories, LLC, with manufacturing by Alkem Laboratories Ltd., Mumbai, India. The label features the Ascend Laboratories logo and an NDC number 67877-587-60.*

FDA Label Image

Eslicarbazepine-800mg-30-tablets (Eslicarbazepine 800mg 30 Tablets)

Label for Eslicarbazepine Acetate Tablets 800 mg, oral tablet dosage form. The label specifies a 30-tablet count and includes storage instructions at 20°C to 25°C. It advises dispensing a medication guide to each patient and notes Rx only. The labeler is Ascend Laboratories, LLC and manufacturing by Alkem Laboratories Ltd., Mumbai, India. Barcode and product codes are shown.*

FDA Label Image

Eslicarbazepine-fig-1 (Eslicarbazepine Fig 1)

A chart illustrating fold change and 90% confidence intervals for eslicarbazepine levels relative to reference across various patient factors. Factors include age (>= 65 years), gender (female), hepatic impairment (mild, moderate, severe), and renal impairment (mild, moderate, severe). Corresponding dosage adjustment recommendations are noted, such as no dose adjustment or dose reduction recommendations for moderate and severe renal impairment.*

FDA Label Image

Eslicarbazepine-fig-2-1 (Eslicarbazepine Fig 2 1)

A chart showing the fold change and 90% confidence interval of eslicarbazepine acetate levels relative to several antiepileptic drugs including Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate. Recommendations for dose adjustment are listed, with Carbamazepine, Phenobarbital, and Phenytoin showing possible need for dose modification of eslicarbazepine acetate.*

FDA Label Image

Eslicarbazepine-fig-3a (Eslicarbazepine Fig 3a)

A forest plot chart showing fold change and 90% confidence intervals for various antiepileptic drugs (AEDs) including Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate. The chart presents changes of these drugs relative to a reference, with accompanying recommendations for dose adjustments or monitoring where applicable.*

FDA Label Image

Eslicarbazepine-fig-3b (Eslicarbazepine Fig 3b)

A horizontal bar chart showing fold change and 90% confidence intervals for various drugs, including Digoxin, Metformin, Simvastatin, Rosuvastatin, Ethinylestradiol, Levonorgestrel, S-Warfarin, and R-Warfarin. The chart includes recommendations linked to each drug, such as dose adjustments for statins and monitoring for Warfarin. The x-axis is labeled 'Change of other drugs relative to reference' with a range from 0.2 to 1.8.*

FDA Label Image

Eslicarbazepine-fig-4.jpg (Eslicarbazepine Fig 4)

A Kaplan-Meier plot showing the estimate of exit rates (%) with 95% confidence intervals for Eslicarbazepine Acetate Tablets at doses of 1200 mg and 1600 mg. Data points represent two studies, with sample sizes (N) indicated for each dose group, compared against historical controls. The y-axis is inverted from 0 to 100%, and study results are marked with diamond and square symbols for Study 1 and Study 2 respectively.*

FDA Label Image

Eslicarbazepine-fig-5.jpg (Eslicarbazepine Fig 5)

A bar graph comparing the proportion of patients by reduction in seizure frequency from baseline in percentage categories for placebo and Eslicarbazepine Acetate Tablets at 800 mg and 1200 mg doses. The x-axis shows seizure frequency reduction intervals (Worse, 0 to <25%, 25 to <50%, 50 to <75%, 75 to 100%), and the y-axis indicates the proportion of patients in percentage.*

* 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.