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United States · US · US:0054-0528_eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80
Rufinamide
Orange BookUNIISPLATC N03AF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN03AF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100540528631 BOTTLE in 1 CARTON (0054-0528-63) / 460 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WFW942PR79
RUFINAMIDE
RxCUI 69036
Orange Book
A207363
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": {
"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": "0054-0528_eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80",
"productndc": "0054-0528",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "207363",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Apr 23, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RUFINAMIDE",
"proprietary_name": "Rufinamide",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA207363",
"marketing_category": "ANDA",
"nonproprietary_name": "Rufinamide",
"start_marketing_date": "20201101",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N03AF03.
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