dofetilide

Generic: dofetilide

Labeler: sigmapharm laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dofetilide
Generic Name dofetilide
Labeler sigmapharm laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dofetilide 125 ug/1

Manufacturer
Sigmapharm Laboratories, LLC

Identifiers & Regulatory

Product NDC 42794-044
Product ID 42794-044_f1f1f93d-aee6-246f-e053-2a95a90a9eee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207746
Listing Expiration 2026-12-31
Marketing Start 2018-06-11

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42794044
Hyphenated Format 42794-044

Supplemental Identifiers

RxCUI
310003 310004 310005
UPC
0342794044106 0342794045103 0342794046100
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 ANDA207746 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 ug/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (42794-044-10)
source: ndc

Packages (1)

42794-044-10 60 CAPSULE in 1 BOTTLE, PLASTIC (42794-044-10)

Ingredients (1)

dofetilide (125 ug/1)

Linked Drug Pages (1)

Dofetilide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f1f1f93d-aee6-246f-e053-2a95a90a9eee", "openfda": {"nui": ["N0000175426"], "upc": ["0342794044106", "0342794045103", "0342794046100"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["0cb2ef7d-e35b-483b-9985-cfef99d7b96f"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Sigmapharm Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (42794-044-10)", "package_ndc": "42794-044-10", "marketing_start_date": "20180611"}], "brand_name": "Dofetilide", "product_id": "42794-044_f1f1f93d-aee6-246f-e053-2a95a90a9eee", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "42794-044", "generic_name": "Dofetilide", "labeler_name": "Sigmapharm Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dofetilide", "active_ingredients": [{"name": "DOFETILIDE", "strength": "125 ug/1"}], "application_number": "ANDA207746", "marketing_category": "ANDA", "marketing_start_date": "20180611", "listing_expiration_date": "20261231"}