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United States · US · US:75929-098_3a98e81d-be3a-16f7-e063-6394a90a6207
Banzel
Orange BookUNIISPLATC N03AF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharma Packaging Solutions, LLC dba Tjoapack LLC
CountryUS (United States)
ATC codeN03AF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117592909812120 TABLET, FILM COATED in 1 BOTTLE (75929-098-12)
- ndc117592909851120 TABLET, FILM COATED in 1 BOTTLE (75929-098-51)
Annotations
UNII (FDA Substance ID)
WFW942PR79
RUFINAMIDE
RxCUI 69036
Orange Book
N021911
ABAB
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": "75929-098_3a98e81d-be3a-16f7-e063-6394a90a6207",
"productndc": "75929-098",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021911",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Nov 14, 2008"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "200MG",
"product_no": "002",
"approval_date": "Nov 14, 2008"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Nov 14, 2008"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RUFINAMIDE",
"proprietary_name": "Banzel",
"active_ingred_unit": "mg/1",
"application_number": "NDA021911",
"marketing_category": "NDA",
"nonproprietary_name": "rufinamide",
"start_marketing_date": "20081114",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code N03AF03.
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