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United States · US · US:68180-803_3db88bc9-af10-4a67-86c5-9f034fa4db9a
RUFINAMIDE
Orange BookUNIISPLATC N03AF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116818080316120 TABLET, FILM COATED in 1 BOTTLE (68180-803-16)
Annotations
UNII (FDA Substance ID)
WFW942PR79
RUFINAMIDE
RxCUI 69036
Orange Book
A204964
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": "68180-803_3db88bc9-af10-4a67-86c5-9f034fa4db9a",
"productndc": "68180-803",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204964",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Aug 17, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "002",
"approval_date": "Aug 17, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Aug 17, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RUFINAMIDE",
"proprietary_name": "RUFINAMIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204964",
"marketing_category": "ANDA",
"nonproprietary_name": "rufinamide",
"start_marketing_date": "20221128",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N03AF03.
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