🇺🇸
United States · US · US:59651-118_1e91567e-437f-4695-8cc6-3e7a8fcb1606
Dofetilide
Orange BookUNIISPLATC C01BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC01BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115965111805500 CAPSULE in 1 BOTTLE (59651-118-05)
- ndc11596511186060 CAPSULE in 1 BOTTLE (59651-118-60)
Annotations
UNII (FDA Substance ID)
R4Z9X1N2ND
DOFETILIDE
RxCUI 49247
Orange Book
A210740
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R4Z9X1N2ND",
"rxcui": "49247",
"inchikey": "IXTMWRCNAAVVAI-UHFFFAOYSA-N",
"display_name": "DOFETILIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"26de5f8c-8cec-46f6-a468-69451758a278": {
"match": "brand_token",
"title": "DOFETILIDE CAPSULE [MAJOR PHARMACEUTICALS]",
"spl_version": "3",
"published_date": "2026-05-21"
}
},
"productid": "59651-118_1e91567e-437f-4695-8cc6-3e7a8fcb1606",
"productndc": "59651-118",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210740",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.125MG",
"product_no": "001",
"approval_date": "Jan 22, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "002",
"approval_date": "Jan 22, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "003",
"approval_date": "Jan 22, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOFETILIDE",
"proprietary_name": "Dofetilide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210740",
"marketing_category": "ANDA",
"nonproprietary_name": "Dofetilide",
"start_marketing_date": "20190122",
"active_numerator_strength": ".125"
}Related drugs
Other records sharing ATC code C01BD04.
Access this data programmatically
Query Dofetilide 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.