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United States · US · US:0078-0357_dcd739ce-e938-40e6-8912-ca4f34b49cf3
Trileptal
Orange BookUNIISPLATC N03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeN03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110078035752250 mL in 1 BOTTLE (0078-0357-52)
Annotations
UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
N021285
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "VZI5B1W380",
"rxcui": "32624",
"inchikey": "CTRLABGOLIVAIY-UHFFFAOYSA-N",
"display_name": "OXCARBAZEPINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b": {
"match": "brand_token",
"title": "TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "39",
"published_date": "2025-12-18"
}
},
"productid": "0078-0357_dcd739ce-e938-40e6-8912-ca4f34b49cf3",
"productndc": "0078-0357",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "021285",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "300MG/5ML",
"product_no": "001",
"approval_date": "May 25, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OXCARBAZEPINE",
"proprietary_name": "Trileptal",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021285",
"marketing_category": "NDA",
"nonproprietary_name": "oxcarbazepine",
"start_marketing_date": "20010530",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code N03AF02.
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