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United States · US · US:51991-054_90534569-92c7-40dd-a902-60e36d3d936c
OXCARBAZEPINE
Orange BookUNIISPLATC N03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBreckenridge Pharmaceutical, Inc.
CountryUS (United States)
ATC codeN03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115199105401100 TABLET, FILM COATED in 1 BOTTLE (51991-054-01)
- ndc115199105405500 TABLET, FILM COATED in 1 BOTTLE (51991-054-05)
Annotations
UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
A078069
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": "51991-054_90534569-92c7-40dd-a902-60e36d3d936c",
"productndc": "51991-054",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078069",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "001",
"approval_date": "Jan 11, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Jan 11, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "003",
"approval_date": "Jan 11, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OXCARBAZEPINE",
"proprietary_name": "OXCARBAZEPINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078069",
"marketing_category": "ANDA",
"nonproprietary_name": "OXCARBAZEPINE",
"start_marketing_date": "20080111",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N03AF02.
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