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United States · US · US:16729-490_40bca241-47f2-b7f0-e063-6294a90a1680
Dofetilide
Orange BookUNIISPLATC C01BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare, Inc.
CountryUS (United States)
ATC codeC01BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11167294901260 CAPSULE in 1 BOTTLE (16729-490-12)
Annotations
UNII (FDA Substance ID)
R4Z9X1N2ND
DOFETILIDE
RxCUI 49247
Orange Book
A213338
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": "16729-490_40bca241-47f2-b7f0-e063-6294a90a1680",
"productndc": "16729-490",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213338",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.125MG",
"product_no": "001",
"approval_date": "Jun 19, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "002",
"approval_date": "Jun 19, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "003",
"approval_date": "Jun 19, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOFETILIDE",
"proprietary_name": "Dofetilide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213338",
"marketing_category": "ANDA",
"nonproprietary_name": "Dofetilide",
"start_marketing_date": "20200820",
"active_numerator_strength": ".125"
}Related drugs
Other records sharing ATC code C01BD04.
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