Aptiom Tablet
Product Images NDC 63402-206

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Aptiom (NDC 63402-206). 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.

FDA Label Image

Principal Display Panel – 200 mg Sample Wallet (Apt03 0010 12)

Aptiom 200 mg (eslicarbazepine acetate) oral tablets packaging label. The label displays blister pack outlines for tablets and includes dosage information. The labeler is Sumitomo Pharma America, Inc., and it states the product is for prescription use only. The label notes a professional sample not for sale or reimbursement, with a package count of 7 tablets. Storage instructions and contact information for Sunovion Pharmaceuticals are also visible.*

FDA Label Image

Principal Display Panel – 400 mg Sample Wallet (Apt03 0010 13)

Aptiom 400 mg tablets packaging label for eslicarbazepine acetate oral tablets. The front panel shows the product name Aptiom with the active ingredient and strength, 400 mg per tablet. The label states Rx only and indicates this is a professional sample not for sale or reimbursement. The package contains 7 tablets. The labeler is Sumitomo Pharma America, Inc., with manufacturing by Sunovion Pharmaceuticals Inc. Additional usage and storage instructions appear on the side panel along with warnings to keep out of reach of children.*

FDA Label Image

Principal Display Panel – 600 mg Sample Wallet (Apt03 0010 14)

Aptiom 600 mg (eslicarbazepine acetate) oral tablets packaging label. The label shows that the package contains 7 tablets, manufactured for Sunovion Pharmaceuticals Inc. The label includes dosage information, storage instructions, and cautionary notes. Aptiom is marked as Rx only and is a professional sample not for sale or reimbursement.*

FDA Label Image

Principal Display Panel – 800 mg Sample Wallet (Apt03 0010 15)

Aptiom 800 mg tablets packaging label for oral use by Sumitomo Pharma America, Inc. The label shows the brand name Aptiom with its generic name eslicarbazepine acetate and strength of 800 mg per tablet. It includes dosage and storage instructions, package details indicating 7 tablets, and a note stating it is a professional sample not for sale or reimbursement.*

FDA Label Image

Principal Display Panel – Titration Sample Pack Wallet (Apt03 0010 16)

Aptiom (eslicarbazepine acetate) tablets packaging label featuring 400 mg and 800 mg oral tablets. The label shows a titration sample pack containing 14 tablets, 7 tablets of 400 mg and 7 tablets of 800 mg, with weekly dosing layout for two weeks. Manufactured for Sumitomo Pharma America, Inc., the packaging includes basic dosing and storage instructions, with product branding and NDC information.*

FDA Label Image

Principal Display Panel – 200 mg Sample Carton (Apt03 0010 17)

Packaging label for Aptiom (eslicarbazepine acetate) 200 mg oral tablets by Sumitomo Pharma America, Inc. The label features dosing information, a note that it is a professional sample not for sale or reimbursement, and instructions to dispense an enclosed Medication Guide. The product is a prescription drug with a once-daily dosing regimen.*

FDA Label Image

Principal Display Panel – 400 mg Sample Carton (Apt03 0010 18)

Packaging label for Aptiom (eslicarbazepine acetate) 400 mg oral tablets by Sumitomo Pharma America, Inc. The label indicates a 400 mg dosage per tablet, with instructions to dispense an enclosed Medication Guide. It states the carton contains 28 tablets or sample cards and is for professional samples, not for sale or reimbursement. The label includes storage instructions and manufacturer information.*

FDA Label Image

Principal Display Panel – 600 mg Sample Carton (Apt03 0010 19)

Aptiom 600 mg Tablets packaging label for oral use tablets containing eslicarbazepine acetate. The label includes dosage strength (600 mg per tablet), the proprietary and generic names, and states that it is a professional sample not for sale or reimbursement. It provides dosage instructions, manufacturer information (Sunovion Pharmaceuticals Inc.), and a barcode. The label features an orange and white color scheme with the Aptiom logo.*

FDA Label Image

Principal Display Panel – 800 mg Sample Carton (Apt03 0010 20)

Aptiom 800 mg tablet packaging label for eslicarbazepine acetate oral tablets. The carton states the strength as 800 mg per tablet and specifies this is a professional sample not for sale or reimbursement. It includes dispensing instructions, storage information, manufacturer details (Sunovion Pharmaceuticals Inc., Marlborough, MA), and a barcode. The packaging highlights that each sample card contains 7 tablets, with a total of 28 tablets in this package.*

FDA Label Image

Principal Display Panel – Titration Sample Pack Carton (Apt03 0010 21)

Aptiom (eslicarbazepine acetate) Tablets packaging label for 400 mg and 800 mg strengths. This is a Titration Sample Pack labeled for once daily oral administration. The label states the product is manufactured by Sunovion Pharmaceuticals, with the package containing 56 tablets divided into 4 titration sample packs. It is marked for professional samples, not for sale or reimbursement.*

FDA Label Image

Apt03 0012 08

Label for Aptiom (eslicarbazepine acetate) 200 mg oral tablets, containing 30 tablets per package. The label includes dosage instructions, storage information, and distributor details for Sunovion Pharmaceuticals Inc., made under license from Bial. It states Rx Only and has barcode and lot number printing area.*

FDA Label Image

Apt03 0012 09

AptiOM 400 mg (eslicarbazepine acetate) oral tablets packaging label from Sumitomo Pharma America, Inc. The bottle contains 30 tablets for prescription use, intended for once-daily dosing. The label includes storage instructions, dispensing warnings, and manufacturer information, noting the product is made in Canada under license from Bial.*

FDA Label Image

Apt03 0012 10

Label for Aptiom (eslicarbazepine acetate) 600 mg oral tablets, containing 60 tablets per package. The label states the product is for prescription use only (Rx only) and includes storage instructions. Manufactured for Sunovion Pharmaceuticals Inc., under license from Bial, made in Canada.*

FDA Label Image

Apt03 0012 11

Label for Aptiom 800 mg tablets, containing the active ingredient eslicarbazepine acetate, for oral use. The label indicates a package of 30 tablets, with directions to see the package insert for dosage. It is labeled Rx only and includes dispensing instructions. Manufactured for Sunovion Pharmaceuticals Inc., made in Canada, under license from Bial.*

FDA Label Image

Apt03 0013 01

Chemical structure of eslicarbazepine acetate, the active ingredient in the drug Aptiom. The structure shows the molecular framework including rings and functional groups characteristic of eslicarbazepine acetate.*

FDA Label Image

Apt03 0013 02

A forest plot chart showing the fold change and 90% confidence interval (CI) of eslicarbazepine change relative to reference based on factors affecting dosage. It includes recommendations for dose adjustment by age (>= 65 years), gender (female), hepatic impairment (mild, moderate, severe), and renal impairment (mild, moderate, severe). The chart notes when no dose adjustment or dose reduction is recommended.*

FDA Label Image

Apt03 0013 03

A horizontal error bar chart showing the fold change in eslicarbazepine levels relative to a reference when coadministered with various drugs including carbamazepine, gabapentin, lamotrigine, levetiracetam, phenobarbital, phenytoin, topiramate, and valproate. The chart also includes clinical recommendations for dose adjustments of Aptiom based on these drug interactions.*

FDA Label Image

Apt03 0013 04

A chart depicting fold changes and 90% confidence intervals for various antiepileptic drugs (AEDs) relative to a reference. It includes drugs such as Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate, with associated recommendations on dose adjustments or monitoring. The x-axis shows the change of other drugs relative to reference.*

FDA Label Image

Apt03 0013 05

A forest plot chart showing fold change with 90% confidence intervals for various drugs when taken with Aptiom. The drugs listed include non-AEDs (Digoxin, Metformin), Statins (Simvastatin, Rosuvastatin), Oral contraceptives (Ethinylestradiol, Levonorgestrel), and Warfarin enantiomers (S-Warfarin, R-Warfarin). Recommendations related to dose adjustments and monitoring are noted alongside the drugs.*

FDA Label Image

Apt03 0013 06

A Kaplan-Meier plot illustrating the exit rate percentages with 95% confidence intervals for Aptiom at 1200 mg and 1600 mg doses compared to historical controls. Data points from two studies show exit rates for Aptiom 1200 mg and 1600 mg, with sample sizes noted for each data point.*

FDA Label Image

Apt03 0013 07

A bar chart showing the proportion of patients (%) versus reduction in seizure frequency from baseline (%). It compares three groups: Placebo, APTIOM 800 mg, and APTIOM 1200 mg, across five categories of seizure reduction: Worse, 0 to <25%, 25 to <50%, 50 to <75%, and 75 to 100%.*

* 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.