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United States · US · US:0069-5800_0109bfef-980f-4bc8-a802-3d3c45587456
Tikosyn
Orange BookUNIISPLATC C01BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeC01BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11006958006060 CAPSULE in 1 BOTTLE (0069-5800-60)
- ndc11006958006114 CAPSULE in 1 BOTTLE (0069-5800-61)
Annotations
UNII (FDA Substance ID)
R4Z9X1N2ND
DOFETILIDE
RxCUI 49247
Orange Book
N020931
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": {
"02438044-d6a3-49e9-a1ac-3aad21ef2c8c": {
"match": "brand_token",
"title": "TIKOSYN (DOFETILIDE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "30",
"published_date": "2026-04-22"
}
},
"productid": "0069-5800_0109bfef-980f-4bc8-a802-3d3c45587456",
"productndc": "0069-5800",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "020931",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.125MG",
"product_no": "001",
"approval_date": "Oct 1, 1999"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "002",
"approval_date": "Oct 1, 1999"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "003",
"approval_date": "Oct 1, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOFETILIDE",
"proprietary_name": "Tikosyn",
"active_ingred_unit": "mg/1",
"application_number": "NDA020931",
"marketing_category": "NDA",
"nonproprietary_name": "dofetilide",
"start_marketing_date": "19991001",
"active_numerator_strength": ".125"
}Related drugs
Other records sharing ATC code C01BD04.
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