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United States · US · US:68462-138_80b48b96-6521-491c-831a-2356c22e39f1
Oxcarbazepine
Orange BookUNIISPLATC N03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeN03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116846213801100 TABLET, FILM COATED in 1 BOTTLE (68462-138-01)
- ndc116846213805500 TABLET, FILM COATED in 1 BOTTLE (68462-138-05)
Annotations
UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
A077802
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": "68462-138_80b48b96-6521-491c-831a-2356c22e39f1",
"productndc": "68462-138",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077802",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "001",
"approval_date": "Oct 9, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Oct 9, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "003",
"approval_date": "Oct 9, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OXCARBAZEPINE",
"proprietary_name": "Oxcarbazepine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077802",
"marketing_category": "ANDA",
"nonproprietary_name": "Oxcarbazepine",
"start_marketing_date": "20071009",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N03AF02.
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