dofetilide

Generic: dofetilide

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dofetilide
Generic Name dofetilide
Labeler exelan pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dofetilide .5 mg/1

Manufacturer
EXELAN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 76282-757
Product ID 76282-757_19f2a722-24ef-44f2-90e6-ec8df457baf6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212750
Listing Expiration 2026-12-31
Marketing Start 2024-11-01

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282757
Hyphenated Format 76282-757

Supplemental Identifiers

RxCUI
310003 310004 310005
UPC
0376282756608 0376282757605
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 ANDA212750 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (76282-757-60)
source: ndc

Packages (1)

76282-757-60 60 CAPSULE in 1 BOTTLE (76282-757-60)

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": "19f2a722-24ef-44f2-90e6-ec8df457baf6", "openfda": {"nui": ["N0000175426"], "upc": ["0376282756608", "0376282757605"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["41ccbb23-ae03-44bd-b438-0b0a8388d56b"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["EXELAN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76282-757-60)", "package_ndc": "76282-757-60", "marketing_start_date": "20241101"}], "brand_name": "Dofetilide", "product_id": "76282-757_19f2a722-24ef-44f2-90e6-ec8df457baf6", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "76282-757", "generic_name": "Dofetilide", "labeler_name": "EXELAN PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dofetilide", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".5 mg/1"}], "application_number": "ANDA212750", "marketing_category": "ANDA", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}