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United States · US · US:31722-431_35c91221-dff8-9144-e063-6394a90a57fb
Eslicarbazepine acetate
Orange BookUNIISPLATC N03AF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11317224313030 TABLET in 1 BOTTLE (31722-431-30)
- ndc11317224313210 BLISTER PACK in 1 CARTON (31722-431-32) / 10 TABLET in 1 BLISTER PACK (31722-431-31)
- ndc11317224319090 TABLET in 1 BOTTLE (31722-431-90)
Annotations
UNII (FDA Substance ID)
BEA68ZVB2K
ESLICARBAZEPINE ACETATE
RxCUI 1482501
Orange Book
A211186
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": {
"d279e461-2611-4f5c-938d-5d117612894f": {
"match": "brand_token",
"title": "ESLICARBAZEPINE ACETATE TABLET [TORRENT PHARMACEUTICALS LIMITED]",
"spl_version": "6",
"published_date": "2025-08-01"
}
},
"productid": "31722-431_35c91221-dff8-9144-e063-6394a90a57fb",
"productndc": "31722-431",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211186",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Aug 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "002",
"approval_date": "Aug 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "003",
"approval_date": "Aug 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "004",
"approval_date": "Aug 3, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESLICARBAZEPINE ACETATE",
"proprietary_name": "Eslicarbazepine acetate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211186",
"marketing_category": "ANDA",
"nonproprietary_name": "Eslicarbazepine acetate",
"start_marketing_date": "20230803",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code N03AF04.
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