dofetilide

Generic: dofetilide

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dofetilide
Generic Name dofetilide
Labeler bionpharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dofetilide .5 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-133
Product ID 69452-133_f7811d48-6a19-d784-e053-6394a90aac27
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208625
Listing Expiration 2026-12-31
Marketing Start 2018-04-11

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452133
Hyphenated Format 69452-133

Supplemental Identifiers

RxCUI
310003 310004 310005
UPC
0369452133170 0369452132173 0369452131176
UNII
R4Z9X1N2ND
NUI
N0000175426

Packaging Origin

Original Packager
true

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 ANDA208625 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (69452-133-17)
source: ndc

Packages (1)

69452-133-17 60 CAPSULE in 1 BOTTLE (69452-133-17)

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": "f7811d48-6a19-d784-e053-6394a90aac27", "openfda": {"nui": ["N0000175426"], "upc": ["0369452133170", "0369452132173", "0369452131176"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["0e60aa4b-72c2-4ef4-ab01-c9cf94240ff1"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (69452-133-17)", "package_ndc": "69452-133-17", "marketing_start_date": "20180411"}], "brand_name": "Dofetilide", "product_id": "69452-133_f7811d48-6a19-d784-e053-6394a90aac27", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "69452-133", "generic_name": "Dofetilide", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dofetilide", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".5 mg/1"}], "application_number": "ANDA208625", "marketing_category": "ANDA", "marketing_start_date": "20180411", "listing_expiration_date": "20261231"}