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United States · US · US:17772-121_41c1a4d4-ff5a-00b4-e063-6294a90a6ec7
OXTELLAR XR
Orange BookUNIISPLATC N03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSupernus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111777212101100 TABLET in 1 BOTTLE (17772-121-01)
- ndc1117772121077 TABLET in 1 BOTTLE (17772-121-07)
- ndc1117772121105 TABLET in 1 BLISTER PACK (17772-121-10)
Annotations
UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
N202810
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": {
"aa610e56-1d1d-11e1-8bc2-0800200c9a66": {
"match": "brand_token",
"title": "OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS PHARMACEUTICALS, INC.]",
"spl_version": "21",
"published_date": "2025-11-17"
}
},
"productid": "17772-121_41c1a4d4-ff5a-00b4-e063-6294a90a6ec7",
"productndc": "17772-121",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202810",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "150MG",
"product_no": "001",
"approval_date": "Oct 19, 2012"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Oct 19, 2012"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "600MG",
"product_no": "003",
"approval_date": "Oct 19, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OXCARBAZEPINE",
"proprietary_name": "OXTELLAR XR",
"active_ingred_unit": "mg/1",
"application_number": "NDA202810",
"marketing_category": "NDA",
"nonproprietary_name": "OXCARBAZEPINE",
"start_marketing_date": "20130117",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code N03AF02.
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