Eslicarbazepine Acetate Tablet
Product Images NDC 59651-535

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Eslicarbazepine Acetate (NDC 59651-535). 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.

FDA Label Image

Fig (Eslicarbazepine Fig1)

A forest plot chart showing fold changes in eslicarbazepine levels with 90% confidence intervals across different factors such as age (≥65 years), gender (female), and hepatic and renal impairment (mild, moderate, severe). The chart includes dosing recommendations corresponding to each condition, indicating dose adjustments where recommended, particularly for moderate and severe renal impairment.*

FDA Label Image

Package Label-principal Display Panel (80 mg (30 Tablets Bottle))

ESLICARBAZEPINE ACETATE 800 mg oral tablet label showing 30 tablets per package. Distributed by Aurobindo Pharma USA, Inc., made in India, with storage instructions and a coding area for GTIN, serial number, expiry date, and lot number. The label includes dosage form and strength, medication guide dispensing note, and a barcode.*

FDA Label Image

Fig2 (Eslicarbazepine Fig2)

A horizontal forest plot chart showing fold changes and 90% confidence intervals in eslicarbazepine levels relative to reference, for different drugs including Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate. Recommendations for dose adjustments with specific drugs are noted in a text table beside the plot.*

FDA Label Image

Fig3 (Eslicarbazepine Fig3)

A table showing fold change with 90% confidence intervals for various antiepileptic drugs (AEDs) and recommendations. It includes AEDs like Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate, with notes on potential dose adjustments or monitoring for specific drugs.*

FDA Label Image

Fig4 (Eslicarbazepine Fig4)

A chart displaying fold change and 90% confidence intervals for various drugs interacting with eslicarbazepine acetate. It includes non-anticonvulsant drugs like Digoxin and Metformin, statins (Simvastatin, Rosuvastatin), oral contraceptives (Ethinylestradiol, Levonorgestrel), and Warfarin variants (S-Warfarin, R-Warfarin). Recommendations for dosage adjustments and monitoring are noted based on observed changes.*

FDA Label Image

Fig5 (Eslicarbazepine Fig5)

A Kaplan-Meier estimate chart showing exit rates (%) with 95% confidence intervals for Eslicarbazepine Acetate at doses of 1200 mg and 1600 mg from two studies. Study 1 data points are diamond-shaped, and Study 2 data points are square-shaped, with sample sizes indicated. Historical control data is included for comparison.*

FDA Label Image

Fig6 (Eslicarbazepine Fig6)

A bar chart comparing the fraction of patients experiencing reductions in seizure frequency from baseline across five reduction ranges: Worse, 0 to <25%, 25 to <50%, 50 to <75%, and 75 to 100%. The chart includes data for placebo and two doses of eslicarbazepine acetate (1000 mg and 1200 mg). Each group is represented by distinct bar patterns, illustrating the proportion of patients in each reduction category.*

FDA Label Image

Package Label-principal Display Panel (200 mg (30 Tablets Bottle))

Label for Eslicarbazepine Acetate Tablets 200 mg oral tablets, provided in a package of 30 tablets by Aurobindo Pharma Limited. The label includes dosing instructions to see the package insert, storage conditions, and distributor information for Aurobindo Pharma USA, Inc. It also indicates the product is Rx only and to dispense the Medication Guide to patients.*

FDA Label Image

Package Label-principal Display Panel (400 mg (30 Tablets Bottle))

Label for Eslicarbazepine Acetate Tablets, 400 mg, oral tablets. The label indicates a 30 tablet count and features the Aurobindo Pharma Limited brand. It includes storage instructions, distribution information for Aurobindo Pharma USA, Inc., and a space designated for coding (GTIN, serial number, expiry date, and lot). The label also notes Rx only and once daily use.*

FDA Label Image

Package Label-principal Display Panel (600 mg (60 Tablets Bottle))

Label for Eslicarbazepine Acetate Tablets, 600 mg strength, oral tablet form. The label indicates the package contains 60 tablets. It includes the NDC 59651-535-60 and states the product is distributed by Aurobindo Pharma USA, Inc., made in India. Storage instructions and a medication guide website are provided. The label is for prescription use, once daily dosing.*

FDA Label Image

Str (Eslicarbazepine Str)

Chemical structure of eslicarbazepine acetate, showing a dibenzazepine core with an acetate ester group attached. The diagram includes rings, nitrogen, oxygen atoms, and the acetate moiety as part of the molecular structure.*

* 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.