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United States · US · US:47335-061_3ea6a12b-26de-4858-aebe-4f8902cc560f
DOFETILIDE
Orange BookUNIISPLATC C01BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeC01BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1147335061794 BLISTER PACK in 1 CARTON (47335-061-79) / 10 CAPSULE in 1 BLISTER PACK (47335-061-66)
- ndc11473350618660 CAPSULE in 1 BOTTLE (47335-061-86)
Annotations
UNII (FDA Substance ID)
R4Z9X1N2ND
DOFETILIDE
RxCUI 49247
Orange Book
A210466
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": "47335-061_3ea6a12b-26de-4858-aebe-4f8902cc560f",
"productndc": "47335-061",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210466",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.125MG",
"product_no": "001",
"approval_date": "Oct 9, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "002",
"approval_date": "Oct 9, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "003",
"approval_date": "Oct 9, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOFETILIDE",
"proprietary_name": "DOFETILIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210466",
"marketing_category": "ANDA",
"nonproprietary_name": "DOFETILIDE",
"start_marketing_date": "20181011",
"active_numerator_strength": ".125"
}Related drugs
Other records sharing ATC code C01BD04.
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