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United States · US · US:60505-4130_f106ef3d-7def-b2e5-2428-60ecd16326f0
OXCARBAZEPINE
Orange BookUNIISPLATC N03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeN03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116050541305500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4130-5)
- ndc116050541307100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4130-7)
Annotations
UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
A213369
ABABAB
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": {
"a18f591b-587e-4769-8ac2-9cfba0b82526": {
"match": "brand_token",
"title": "OXCARBAZEPINE (OXCARBAZEPINE) SUSPENSION [CAMBER PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2026-05-25"
}
},
"productid": "60505-4130_f106ef3d-7def-b2e5-2428-60ecd16326f0",
"productndc": "60505-4130",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213369",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "001",
"approval_date": "Jul 13, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Jul 13, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "003",
"approval_date": "Jul 13, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OXCARBAZEPINE",
"proprietary_name": "OXCARBAZEPINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213369",
"marketing_category": "ANDA",
"nonproprietary_name": "OXCARBAZEPINE",
"start_marketing_date": "20240903",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N03AF02.
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