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United States · US · US:68462-713_18421d5f-9e93-4abb-8abe-855bab5d243e
rufinamide
Orange BookUNIISPLATC N03AF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeN03AF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116846271305500 TABLET, FILM COATED in 1 BOTTLE (68462-713-05)
- ndc116846271308120 TABLET, FILM COATED in 1 BOTTLE (68462-713-08)
- ndc11684627133030 TABLET, FILM COATED in 1 BOTTLE (68462-713-30)
Annotations
UNII (FDA Substance ID)
WFW942PR79
RUFINAMIDE
RxCUI 69036
Orange Book
A205075
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": "68462-713_18421d5f-9e93-4abb-8abe-855bab5d243e",
"productndc": "68462-713",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205075",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "May 16, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "002",
"approval_date": "May 16, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RUFINAMIDE",
"proprietary_name": "rufinamide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205075",
"marketing_category": "ANDA",
"nonproprietary_name": "rufinamide",
"start_marketing_date": "20160516",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N03AF03.
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