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United States · US · US:72205-039_feb8626e-9d88-4a06-919f-f8169a69814b
Dofetilide
Orange BookUNIISPLATC C01BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeC01BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1172205039374 BLISTER PACK in 1 CARTON (72205-039-37) / 10 CAPSULE in 1 BLISTER PACK (72205-039-11)
- ndc11722050396060 CAPSULE in 1 BOTTLE (72205-039-60)
Annotations
UNII (FDA Substance ID)
R4Z9X1N2ND
DOFETILIDE
RxCUI 49247
Orange Book
A213220
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": "72205-039_feb8626e-9d88-4a06-919f-f8169a69814b",
"productndc": "72205-039",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213220",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.125MG",
"product_no": "001",
"approval_date": "Jan 29, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "002",
"approval_date": "Jan 29, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "003",
"approval_date": "Jan 29, 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": "ANDA213220",
"marketing_category": "ANDA",
"nonproprietary_name": "Dofetilide",
"start_marketing_date": "20200612",
"active_numerator_strength": ".125"
}Related drugs
Other records sharing ATC code C01BD04.
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