Aptiom Kit
Product Images NDC 63402-248

Product Visual Gallery

This gallery contains 23 technical images submitted to the FDA as part of the official labeling for Aptiom (NDC 63402-248). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sumitomo Pharma America, 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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Chemical Structure (Apt03 0019 01)

Chemical structure of Eslicarbazepine Acetate, the active ingredient in Aptiom. The structure shows a fused ring system with functional groups including an acetate moiety and an amide group attached to a nitrogen atom within the bicyclic framework.*

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Figure 1 (Apt03 0019 02)

A forest plot chart depicting dose adjustment recommendations for Eslicarbazepine acetate (Aptiom) based on age, gender, hepatic impairment, and renal impairment. The chart shows fold changes and confidence intervals for these factors and corresponding dosing recommendations, such as no dose adjustment for mild hepatic impairment and dose reduction for moderate to severe renal impairment.*

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Figure 2 (Apt03 0019 03)

A horizontal error bar chart comparing the fold change and 90% confidence intervals of eslicarbazepine levels relative to a reference when co-administered with various drugs including Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate. Recommendations on dose adjustments for Aptiom are noted alongside each drug, with dose adjustments suggested for Carbamazepine, Phenobarbital, and Phenytoin, but none for the others.*

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Figure 3a (Apt03 0019 04)

A chart depicting fold change and 90% confidence intervals for various antiepileptic drugs (AEDs) relative to a reference, along with dosing recommendations. Drugs listed include Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate. The chart indicates potential dose adjustments or monitoring requirements for certain drugs based on clinical response.*

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Figure 3b (Apt03 0019 05)

A forest plot chart depicting fold change and 90% confidence intervals for various drugs including AEDs, statins, oral contraceptives, and warfarin, with corresponding recommendations related to dose adjustments or patient monitoring. The x-axis represents the change of other drugs relative to reference values.*

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Figure 4 (Apt03 0019 06)

A Kaplan-Meier estimate plot showing exit rates with 95% confidence intervals for Aptiom at 1200 mg and 1600 mg doses compared to historical controls. Data points from two studies are shown with sample sizes, illustrating differences in exit rates at these dosages.*

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Figure 5 (Apt03 0019 07)

A bar chart comparing the proportion of patients experiencing different ranges of seizure frequency reduction from baseline, including categories from 'Worse' to '75 to 100%', among placebo and Aptiom (eslicarbazepine acetate) 800 mg and 1200 mg groups. The vertical axis shows the proportion of patients in percentage, while the horizontal axis indicates seizure frequency reduction categories.*

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Sumitomo Pharma Logo (Apt03 0019 08)

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Bial Logo (Apt03 0019 09)

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Principal Display Panel – 200 mg 30 Count Oblong Bottle (Apt03 0019 10)

Aptiom 200 mg eslicarbazepine acetate oral tablets label showing a package size of 30 tablets. The label includes the dosage strength, NDC number 63402-202-30, and states Rx only. It features the Sumitomo Pharma logo and indicates the medication is manufactured for Sumitomo Pharma America, Inc. The label also advises dispensing with the Medication Guide and includes storage and safety information.*

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Principal Display Panel – 400 mg 30 Count Oblong Bottle (Apt03 0019 11)

Aptiom (eslicarbazepine acetate) 400 mg oral tablets label, showing packaging for 30 tablets. The label includes dosage strength, product name, and directions to dispenses with the Medication Guide. Manufactured by Sumitomo Pharma America, Inc., under license from BIAL. NDC 63402-204-30.*

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Principal Display Panel – 600 mg 60 Count Oblong Bottle (Apt03 0019 12)

Aptiom (eslicarbazepine acetate) 600 mg oral tablets label. The label states it contains 60 tablets with a once daily dose. It is manufactured by Sumitomo Pharma America, Inc. The label indicates Rx only and includes storage information and a dispenser warning about providing the Medication Guide with each dispense. The label features barcodes, a QR code, and licensing information from Bial.*

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Principal Display Panel – 800 mg 30 Count Oblong Bottle (Apt03 0019 13)

Aptiom 800 mg (eslicarbazepine acetate) oral tablets packaging label showing a bottle of 30 tablets. The label includes the product name, strength, dosage form, and manufacturer Sumitomo Pharma America, Inc. It also notes the prescription-only status and storage instructions.*

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Principal Display Panel – 200 mg Sample Wallet (Apt03 0019 14)

Aptiom 200 mg tablets packaging label for eslicarbazepine acetate oral tablets. The label shows the brand name Aptiom with active ingredient, strength 200 mg, and 'once daily' dosage. The package contains 7 tablets and is marked as a professional sample not for sale or reimbursement. Manufactured for Sunovion Pharmaceuticals Inc., with storage and dosage instructions included.*

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Principal Display Panel – 400 mg Sample Wallet (Apt03 0019 15)

Aptiom 400 mg (eslicarbazepine acetate) oral tablets packaging label. The label shows the brand and generic names, strength of 400 mg per tablet, and that it is a prescription drug. The package contains 7 tablets and is marked as a professional sample not for sale or reimbursement. Manufactured for Sunovion Pharmaceuticals Inc., with storage instructions and dosage directions included.*

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Principal Display Panel – 600 mg Sample Wallet (Apt03 0019 16)

Aptiom (eslicarbazepine acetate) 600 mg oral tablets packaging label. The label indicates the strength of 600 mg per tablet and includes the instructions for usual dosage, storage conditions, safety warnings, and manufacturer information. The labeler is Sumitomo Pharma America, Inc. The package contains 7 tablets and is marked as a professional sample, not for sale or reimbursement.*

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Principal Display Panel – 800 mg Sample Wallet (Apt03 0019 17)

Aptiom 800 mg tablets packaging label for oral use. The label displays the brand name Aptiom and the generic name eslicarbazepine acetate, indicating the strength as 800 mg per tablet. It specifies the product is manufactured for Sunovion Pharmaceuticals Inc., includes storage instructions, dosage direction to take once daily, and the NDC code 63402-208-07. The package contains 7 tablets and notes that it is a professional sample not for sale or reimbursement.*

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Principal Display Panel – Titration Sample Pack Wallet (Apt03 0019 18)

Aptiom tablets packaging label featuring 400 mg and 800 mg strengths of eslicarbazepine acetate tablets for oral use. The label includes instructions for a two-week titration sample pack with 7 tablets of each strength, dosage instructions, storage conditions, warnings, and manufacturer information from Sumitomo Pharma America, Inc.*

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Principal Display Panel – 200 mg Sample Carton (Apt03 0019 19)

Aptiom 200 mg tablets packaging label for oral use, containing eslicarbazepine acetate. The label displays the brand name Aptiom with the generic name and strength, 200 mg per tablet, prominently shown. It includes instructions for dispensing with a medication guide, indicates the product is a prescription drug (Rx only), and notes the package contains 28 tablets or 4 sample cards. Manufactured for Sunovion Pharmaceuticals Inc., Marlborough, MA, and made in Canada, this professional sample is not for sale or reimbursement.*

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Principal Display Panel – 400 mg Sample Carton (Apt03 0019 20)

Packaging label for Aptiom (eslicarbazepine acetate) 400 mg oral tablets by Sumitomo Pharma America, Inc. The carton indicates 28 tablets or 4 sample cards, each containing 7 tablets. Label includes dosage form, strength, storage instructions, and professional sample notice. The label features green and blue graphic elements and states the product is made under license from BIAL by Sunovion Pharmaceuticals Inc.*

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Principal Display Panel – 600 mg Sample Carton (Apt03 0019 21)

Aptiom 600 mg tablets carton label showing eslicarbazepine acetate as the active ingredient. The label includes dosage strength of 600 mg per tablet, directions to dispense an enclosed Medication Guide, and states the package contains 28 tablets or 4 sample cards. It is marked for professional samples, not for sale or reimbursement, and manufactured for Sunovion Pharmaceuticals, Marlborough, MA. The label also includes storage instructions and safety warnings.*

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Principal Display Panel – 800 mg Sample Carton (Apt03 0019 22)

Carton label for Aptiom (eslicarbazepine acetate) 800 mg oral tablets by Sumitomo Pharma America, Inc. The label states once daily dosing with 28 tablets per carton. It includes dosage instructions, warnings to keep out of reach of children, storage conditions, and manufacturer details. Marked as professional samples not for sale or reimbursement.*

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Principal Display Panel – Titration Sample Pack Carton (Apt03 0019 23)

Packaging label for Aptiom (eslicarbazepine acetate) tablets, 400 mg and 800 mg strengths. This is a titration sample pack containing tablets for oral use. The labeler is Sumitomo Pharma America, Inc. The label features dosage information and instructions indicating the product is for professional sample use, not for sale or reimbursement.*

* 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.