dofetilide

Generic: dofetilide

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dofetilide .125 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-039
Product ID 72205-039_feb8626e-9d88-4a06-919f-f8169a69814b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213220
Listing Expiration 2026-12-31
Marketing Start 2020-06-12

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205039
Hyphenated Format 72205-039

Supplemental Identifiers

RxCUI
310003 310004 310005
UPC
0372205039605 0372205040601 0372205041608
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 ANDA213220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .125 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (72205-039-37) / 10 CAPSULE in 1 BLISTER PACK (72205-039-11)
  • 60 CAPSULE in 1 BOTTLE (72205-039-60)
source: ndc

Packages (2)

72205-039-37 4 BLISTER PACK in 1 CARTON (72205-039-37) / 10 CAPSULE in 1 BLISTER PACK (72205-039-11) 72205-039-60 60 CAPSULE in 1 BOTTLE (72205-039-60)

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": "feb8626e-9d88-4a06-919f-f8169a69814b", "openfda": {"nui": ["N0000175426"], "upc": ["0372205039605", "0372205040601", "0372205041608"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["b8323987-90fe-4e6c-a71c-76e3c501713c"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (72205-039-37)  / 10 CAPSULE in 1 BLISTER PACK (72205-039-11)", "package_ndc": "72205-039-37", "marketing_start_date": "20200612"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (72205-039-60)", "package_ndc": "72205-039-60", "marketing_start_date": "20200612"}], "brand_name": "Dofetilide", "product_id": "72205-039_feb8626e-9d88-4a06-919f-f8169a69814b", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "72205-039", "generic_name": "Dofetilide", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dofetilide", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".125 mg/1"}], "application_number": "ANDA213220", "marketing_category": "ANDA", "marketing_start_date": "20200612", "listing_expiration_date": "20261231"}