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United States · US · US:62856-584_0cc6f13a-0289-45f7-980e-3196d7489d75
Banzel
Orange BookUNIISPLATC N03AF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEisai Inc.
CountryUS (United States)
ATC codeN03AF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162856584461 BOTTLE in 1 CARTON (62856-584-46) / 460 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WFW942PR79
RUFINAMIDE
RxCUI 69036
Orange Book
N201367
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WFW942PR79",
"rxcui": "69036",
"inchikey": "POGQSBRIGCQNEG-UHFFFAOYSA-N",
"display_name": "RUFINAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0a3fa925-1abd-458a-bd57-4ae780a1ef2d": {
"match": "brand_token",
"title": "BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.]",
"spl_version": "45",
"published_date": "2024-11-18"
}
},
"productid": "62856-584_0cc6f13a-0289-45f7-980e-3196d7489d75",
"productndc": "62856-584",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "201367",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Mar 3, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RUFINAMIDE",
"proprietary_name": "Banzel",
"active_ingred_unit": "mg/mL",
"application_number": "NDA201367",
"marketing_category": "NDA",
"nonproprietary_name": "rufinamide",
"start_marketing_date": "20110303",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N03AF03.
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