Dofetilide

Orange BookUNIISPLATC C01BD04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBionpharma Inc.

CountryUS (United States)

ATC codeC01BD04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6945213117
60 CAPSULE in 1 BOTTLE (69452-131-17)

Annotations

UNII (FDA Substance ID)

R4Z9X1N2ND

DOFETILIDE

RxCUI 49247

Orange Book

A208625

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": "69452-131_f7811d48-6a19-d784-e053-6394a90aac27",
  "productndc": "69452-131",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208625",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.125MG",
        "product_no": "001",
        "approval_date": "Apr 10, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "002",
        "approval_date": "Apr 10, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "003",
        "approval_date": "Apr 10, 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": "ANDA208625",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dofetilide",
  "start_marketing_date": "20180411",
  "active_numerator_strength": ".125"
}

Related drugs

Other records sharing ATC code C01BD04.

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