🇺🇸
United States · US · US:42571-391_fbdca190-53fc-29e9-e053-6394a90abafe
RUFINAMIDE
Orange BookUNIISPLATC N03AF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeN03AF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114257139112120 TABLET in 1 BOTTLE (42571-391-12)
Annotations
UNII (FDA Substance ID)
WFW942PR79
RUFINAMIDE
RxCUI 69036
Orange Book
A216688
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": "42571-391_fbdca190-53fc-29e9-e053-6394a90abafe",
"productndc": "42571-391",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216688",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "May 15, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "002",
"approval_date": "May 15, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RUFINAMIDE",
"proprietary_name": "RUFINAMIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216688",
"marketing_category": "ANDA",
"nonproprietary_name": "RUFINAMIDE",
"start_marketing_date": "20230701",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N03AF03.
Access this data programmatically
Query RUFINAMIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.