dofetilide

Generic: dofetilide

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dofetilide
Generic Name dofetilide
Labeler northstar rxllc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dofetilide .5 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-132
Product ID 72603-132_d9cc5e83-13c7-40a5-86d3-29216f7f55fe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210466
Listing Expiration 2026-12-31
Marketing Start 2023-02-07

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603132
Hyphenated Format 72603-132

Supplemental Identifiers

RxCUI
310003 310004 310005
UPC
0372603130010 0372603132014 0372603131017
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 ANDA210466 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (72603-132-01)
source: ndc

Packages (1)

72603-132-01 60 CAPSULE in 1 BOTTLE (72603-132-01)

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": "d9cc5e83-13c7-40a5-86d3-29216f7f55fe", "openfda": {"nui": ["N0000175426"], "upc": ["0372603130010", "0372603132014", "0372603131017"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["4552d82a-dd28-410c-9642-1af060832b47"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (72603-132-01)", "package_ndc": "72603-132-01", "marketing_start_date": "20230207"}], "brand_name": "DOFETILIDE", "product_id": "72603-132_d9cc5e83-13c7-40a5-86d3-29216f7f55fe", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "72603-132", "generic_name": "DOFETILIDE", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOFETILIDE", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".5 mg/1"}], "application_number": "ANDA210466", "marketing_category": "ANDA", "marketing_start_date": "20230207", "listing_expiration_date": "20261231"}