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United States · US · US:76282-757_19f2a722-24ef-44f2-90e6-ec8df457baf6
Dofetilide
Orange BookUNIISPLATC C01BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEXELAN PHARMACEUTICALS, INC.
CountryUS (United States)
ATC codeC01BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11762827576060 CAPSULE in 1 BOTTLE (76282-757-60)
Annotations
UNII (FDA Substance ID)
R4Z9X1N2ND
DOFETILIDE
RxCUI 49247
Orange Book
A212750
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": "76282-757_19f2a722-24ef-44f2-90e6-ec8df457baf6",
"productndc": "76282-757",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212750",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.125MG",
"product_no": "001",
"approval_date": "Oct 14, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "002",
"approval_date": "Oct 14, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "003",
"approval_date": "Oct 14, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOFETILIDE",
"proprietary_name": "Dofetilide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212750",
"marketing_category": "ANDA",
"nonproprietary_name": "Dofetilide",
"start_marketing_date": "20241101",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code C01BD04.
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