Dofetilide

Generic: Dofetilide

Labeler: Mayne Pharma Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Dofetilide
Generic Name Dofetilide
Labeler Mayne Pharma Inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

DOFETILIDE .5 mg/1

Identifiers & Regulatory

Product NDC 51862-005
Product ID 51862-005_4a7bd9d4-6854-c23c-e063-6294a90a94de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207058
Marketing Start 2016-06-07
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862005
Hyphenated Format 51862-005

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name Dofetilide (source: ndc)
Generic Name Dofetilide (source: ndc)
Application Number ANDA207058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (51862-005-60)
source: ndc

Packages (1)

51862-005-60 60 CAPSULE in 1 BOTTLE, PLASTIC (51862-005-60)

Ingredients (1)

DOFETILIDE (.5 mg/1)

Linked Drug Pages (1)

Dofetilide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a7bd9d4-6854-c23c-e063-6294a90a94de", "openfda": {"nui": ["N0000175426"], "upc": ["0351862025602"], "unii": ["R4Z9X1N2ND"], "spl_set_id": ["a806d3d2-d4c1-461c-b2e4-8807bfb59cb8"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (51862-005-60)", "package_ndc": "51862-005-60", "marketing_end_date": "20260228", "marketing_start_date": "20160607"}], "brand_name": "Dofetilide", "product_id": "51862-005_4a7bd9d4-6854-c23c-e063-6294a90a94de", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "51862-005", "generic_name": "Dofetilide", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dofetilide", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207058", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20160607"}