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United States · US · US:70010-024_44f3f63d-4521-91e4-e063-6394a90a6d1b
Dofetilide 0.125mg
Orange BookUNIISPLATC C01BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGranules Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC01BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11700100240660 CAPSULE in 1 BOTTLE (70010-024-06)
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": "70010-024_44f3f63d-4521-91e4-e063-6394a90a6d1b",
"productndc": "70010-024",
"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 0.125mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212750",
"marketing_category": "ANDA",
"nonproprietary_name": "Dofetilide 0.125mg",
"start_marketing_date": "20241114",
"active_numerator_strength": ".125"
}Related drugs
Other records sharing ATC code C01BD04.
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