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United States · US · US:31722-598_c3c611a2-394b-4427-e053-2a95a90a433f
Rufinamide
Orange BookUNIISPLATC N03AF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc113172259812120 TABLET, FILM COATED in 1 BOTTLE (31722-598-12)
- ndc11317225983030 TABLET, FILM COATED in 1 BOTTLE (31722-598-30)
Annotations
UNII (FDA Substance ID)
WFW942PR79
RUFINAMIDE
RxCUI 69036
Orange Book
A204993
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": {
"da9ee326-a383-4d46-9d4e-fcc2be3d2680": {
"match": "brand_token",
"title": "RUFINAMIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]",
"spl_version": "4",
"published_date": "2026-01-26"
}
},
"productid": "31722-598_c3c611a2-394b-4427-e053-2a95a90a433f",
"productndc": "31722-598",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204993",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "May 11, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "002",
"approval_date": "May 11, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RUFINAMIDE",
"proprietary_name": "Rufinamide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204993",
"marketing_category": "ANDA",
"nonproprietary_name": "Rufinamide",
"start_marketing_date": "20210511",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N03AF03.
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