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United States · US · US:68382-693_f743cc83-a47d-4a48-8be5-516be5c7d7e8
oxcarbazepine
Orange BookUNIISPLATC N03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeN03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116838269301100 TABLET in 1 BOTTLE (68382-693-01)
- ndc116838269305500 TABLET in 1 BOTTLE (68382-693-05)
- ndc11683826933010 BLISTER PACK in 1 CARTON (68382-693-30) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
A211747
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": "68382-693_f743cc83-a47d-4a48-8be5-516be5c7d7e8",
"productndc": "68382-693",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211747",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "150MG",
"product_no": "001",
"approval_date": "Jul 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "300MG",
"product_no": "002",
"approval_date": "Jul 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "003",
"approval_date": "Jul 3, 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": "ANDA211747",
"marketing_category": "ANDA",
"nonproprietary_name": "oxcarbazepine",
"start_marketing_date": "20250710",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N03AF02.
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