dofetilide

Generic: dofetilide

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dofetilide
Generic Name dofetilide
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dofetilide .125 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7522
Product ID 0904-7522_163839ff-a9c4-428a-a920-65dd07532384
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207058
Listing Expiration 2026-12-31
Marketing Start 2024-10-17

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047522
Hyphenated Format 0904-7522

Supplemental Identifiers

RxCUI
310003 310004 310005
UNII
R4Z9X1N2ND
NUI
N0000175426

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 ANDA207058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .125 mg/1
source: ndc
Packaging
  • 40 BLISTER PACK in 1 CARTON (0904-7522-08) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7522-08 40 BLISTER PACK in 1 CARTON (0904-7522-08) / 1 CAPSULE in 1 BLISTER PACK

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": "163839ff-a9c4-428a-a920-65dd07532384", "openfda": {"nui": ["N0000175426"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["26de5f8c-8cec-46f6-a468-69451758a278"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "40 BLISTER PACK in 1 CARTON (0904-7522-08)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7522-08", "marketing_start_date": "20241017"}], "brand_name": "Dofetilide", "product_id": "0904-7522_163839ff-a9c4-428a-a920-65dd07532384", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "0904-7522", "generic_name": "Dofetilide", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dofetilide", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".125 mg/1"}], "application_number": "ANDA207058", "marketing_category": "ANDA", "marketing_start_date": "20241017", "listing_expiration_date": "20261231"}