dofetilide

Generic: dofetilide

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dofetilide
Generic Name dofetilide
Labeler accord healthcare, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dofetilide .125 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-490
Product ID 16729-490_40bca241-47f2-b7f0-e063-6294a90a1680
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213338
Listing Expiration 2026-12-31
Marketing Start 2020-08-20

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729490
Hyphenated Format 16729-490

Supplemental Identifiers

RxCUI
310003 310004 310005
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 ANDA213338 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .125 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (16729-490-12)
source: ndc

Packages (1)

16729-490-12 60 CAPSULE in 1 BOTTLE (16729-490-12)

Ingredients (1)

dofetilide (.125 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": "40bca241-47f2-b7f0-e063-6294a90a1680", "openfda": {"nui": ["N0000175426"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["4c1a5a6d-bd69-473c-8caa-d0d242b7708d"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (16729-490-12)", "package_ndc": "16729-490-12", "marketing_start_date": "20200820"}], "brand_name": "Dofetilide", "product_id": "16729-490_40bca241-47f2-b7f0-e063-6294a90a1680", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "16729-490", "generic_name": "Dofetilide", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dofetilide", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".125 mg/1"}], "application_number": "ANDA213338", "marketing_category": "ANDA", "marketing_start_date": "20200820", "listing_expiration_date": "20261231"}