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United States · US · US:63402-206_3af99c5d-50e2-4336-8a5e-e93b6cf3618a
Aptiom
Orange BookUNIISPLATC N03AF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSumitomo Pharma America, Inc.
CountryUS (United States)
ATC codeN03AF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1163402206284 BLISTER PACK in 1 CARTON (63402-206-28) / 7 TABLET in 1 BLISTER PACK (63402-206-07)
- ndc11634022066060 TABLET in 1 BOTTLE (63402-206-60)
Annotations
UNII (FDA Substance ID)
BEA68ZVB2K
ESLICARBAZEPINE ACETATE
RxCUI 1482501
Orange Book
N022416
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BEA68ZVB2K",
"rxcui": "1482501",
"inchikey": "QIALRBLEEWJACW-INIZCTEOSA-N",
"display_name": "ESLICARBAZEPINE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3d0c9554-eaeb-4694-8089-00133fcadce3": {
"match": "brand_token",
"title": "APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUMITOMO PHARMA AMERICA, INC.]",
"spl_version": "16",
"published_date": "2023-12-05"
}
},
"productid": "63402-206_3af99c5d-50e2-4336-8a5e-e93b6cf3618a",
"productndc": "63402-206",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "022416",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Nov 8, 2013"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "400MG",
"product_no": "002",
"approval_date": "Nov 8, 2013"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "600MG",
"product_no": "003",
"approval_date": "Nov 8, 2013"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "800MG",
"product_no": "004",
"approval_date": "Nov 8, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESLICARBAZEPINE ACETATE",
"proprietary_name": "Aptiom",
"active_ingred_unit": "mg/1",
"application_number": "NDA022416",
"marketing_category": "NDA",
"nonproprietary_name": "ESLICARBAZEPINE ACETATE",
"start_marketing_date": "20140407",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N03AF04.
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