Eslicarbazepine Acetate Tablet
Product Images NDC 31722-428

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Eslicarbazepine Acetate (NDC 31722-428). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

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Eslicarbazipine-structure (Eslicarbazipine Structure)

Chemical structure diagram of Eslicarbazepine acetate, showing its molecular framework including rings, functional groups, and connectivity.*

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Figure-1 (Figure 1)

A data table showing fold changes and 90% confidence intervals for eslicarbazepine acetate exposure relative to reference values by patient factors including age (>=65 years), gender (female), hepatic impairment (mild, moderate, severe), and renal impairment (mild, moderate, severe). The table includes dosing recommendations corresponding to each condition, such as no dose adjustment for age, gender, mild hepatic impairment, and mild renal impairment, and dose reduction recommended for moderate and severe renal impairment.*

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Figure-2 (Figure 2)

A forest plot chart showing the fold change and 90% confidence interval of eslicarbazepine acetate levels relative to reference when co-administered with various drugs. The chart lists Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate, along with corresponding recommendations for dose adjustments, noting that Carbamazepine, Phenobarbital, and Phenytoin may require dose changes while others do not.*

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Figure-3a (Figure 3a)

A chart showing fold change and 90% confidence intervals for various antiepileptic drugs (AEDs) relative to a reference, along with dosage recommendations. The drugs listed include carbamazepine, gabapentin, lamotrigine, levetiracetam, phenobarbital, phenytoin, topiramate, and valproate. The recommendations range from no dose adjustment needed to monitoring plasma concentration and possible dose adjustment for phenytoin.*

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Figure-3b (Figure 3b)

A chart showing fold change and 90% confidence intervals in plasma concentrations of various non-antiepileptic drugs (Digoxin, Metformin, Statins like Simvastatin and Rosuvastatin, Oral Contraceptives Ethinylestradiol and Levonorgestrel, and Warfarin forms) relative to a reference when taken with Eslicarbazepine acetate. Recommendations on dosage adjustments or monitoring accompany each drug where changes are noted.*

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Figure-4 (Figure 4)

A Kaplan-Meier estimate chart displaying the exit rates (%) with 95% confidence intervals for Eslicarbazepine Acetate at doses of 1200 mg and 1600 mg from two studies. The chart compares exit rates from Study 1 (diamonds) and Study 2 (squares) against historical controls (dashed line). Sample sizes (N) for each study group are annotated next to the data points.*

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Figure-5 (Figure 5)

A bar chart showing the proportion of patients (%) in categories of seizure frequency reduction from baseline for three groups: Placebo (N=406), Eslicarbazepine acetate 800 mg (N=375), and Eslicarbazepine acetate 1200 mg (N=352). Categories on the x-axis include Worse, 0 to <25%, 25 to <50%, 50 to <75%, and 75 to 100% reduction in seizure frequency.*

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Camber-logo (Camber Logo)

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Camber-logo-2 (Camber Logo 2)

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200mg-30s-container (200mg 30s Container)

Label for Eslicarbazepine Acetate Tablets 200 mg by Camber Pharmaceuticals, Inc. The label indicates a 30-tablet package, prescription only, with instructions to dispense the Medication Guide. Storage instructions and manufacturer details are included, with manufacturing by Hetero Labs Limited, India. The label features a barcode and contact information.*

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400mg-30s-container (400mg 30s Container)

Label for Eslicarbazepine Acetate Tablets 400 mg, an oral tablet formulation by Camber Pharmaceuticals, Inc. The label states a package size of 30 tablets and includes storage instructions, a pharmacist dispensing note, and manufacturing details by Hetero Labs Limited in India. A barcode and contact information for Camber Pharmaceuticals are also present.*

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600mg-60s-container (600mg 60s Container)

Label for Eslicarbazepine Acetate Tablets 600 mg oral tablets by Camber Pharmaceuticals, Inc. The label states a package size of 60 tablets. It includes storage instructions, a U.S. contact number, and manufacturing details, noting that the product is manufactured by Hetero Labs Limited, India. A barcode is also visible.*

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600mg-90s-container (600mg 90s Container)

Label for Eslicarbazepine Acetate Tablets 600 mg oral tablets by Camber Pharmaceuticals, Inc. The label indicates the product is once daily dosage with 90 tablets per container. Storage instructions and a pharmacist note about dispensing the medication guide are included. Manufactured for Camber Pharmaceuticals with production by Hetero Labs Limited.*

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800mg-30s-container (800mg 30s Container)

Label for Eslicarbazepine Acetate Tablets 800 mg, oral tablets, once daily, by Camber Pharmaceuticals, Inc. The label indicates 30 tablets per package. It includes storage instructions, a contact number, and manufacturing information showing production for Camber Pharmaceuticals by Hetero Labs Limited in India. The label features a barcode and a website for the medication guide.*

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800mg-90s-container (800mg 90s Container)

Label for Eslicarbazepine Acetate Tablets 800 mg by Camber Pharmaceuticals, Inc. The label indicates a quantity of 90 tablets for oral use, with the instruction "Once Daily." It includes storage information, a pharmacist dispensing note, contact information, and manufacturing details including a barcode.*

* 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.