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United States · US · US:42794-045_f1f1f93d-aee6-246f-e053-2a95a90a9eee
Dofetilide
Orange BookUNIISPLATC C01BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSigmapharm Laboratories, LLC
CountryUS (United States)
ATC codeC01BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11427940451060 CAPSULE in 1 BOTTLE, PLASTIC (42794-045-10)
Annotations
UNII (FDA Substance ID)
R4Z9X1N2ND
DOFETILIDE
RxCUI 49247
Orange Book
A207746
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": "42794-045_f1f1f93d-aee6-246f-e053-2a95a90a9eee",
"productndc": "42794-045",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "207746",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.125MG",
"product_no": "001",
"approval_date": "Mar 26, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "002",
"approval_date": "Mar 26, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "003",
"approval_date": "Mar 26, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOFETILIDE",
"proprietary_name": "Dofetilide",
"active_ingred_unit": "ug/1",
"application_number": "ANDA207746",
"marketing_category": "ANDA",
"nonproprietary_name": "Dofetilide",
"start_marketing_date": "20180611",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code C01BD04.
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