dofetilide

Generic: dofetilide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dofetilide
Generic Name dofetilide
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dofetilide .5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-120
Product ID 59651-120_1e91567e-437f-4695-8cc6-3e7a8fcb1606
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210740
Listing Expiration 2026-12-31
Marketing Start 2019-01-22

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651120
Hyphenated Format 59651-120

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 ANDA210740 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (59651-120-05)
  • 60 CAPSULE in 1 BOTTLE (59651-120-60)
source: ndc

Packages (2)

59651-120-05 500 CAPSULE in 1 BOTTLE (59651-120-05) 59651-120-60 60 CAPSULE in 1 BOTTLE (59651-120-60)

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": "1e91567e-437f-4695-8cc6-3e7a8fcb1606", "openfda": {"nui": ["N0000175426"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["85f2b35c-31d5-4161-b342-c781d23945a5"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (59651-120-05)", "package_ndc": "59651-120-05", "marketing_start_date": "20190122"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (59651-120-60)", "package_ndc": "59651-120-60", "marketing_start_date": "20190122"}], "brand_name": "Dofetilide", "product_id": "59651-120_1e91567e-437f-4695-8cc6-3e7a8fcb1606", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "59651-120", "generic_name": "Dofetilide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dofetilide", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".5 mg/1"}], "application_number": "ANDA210740", "marketing_category": "ANDA", "marketing_start_date": "20190122", "listing_expiration_date": "20261231"}