dofetilide

Generic: dofetilide

Labeler: dr. reddy's labratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dofetilide
Generic Name dofetilide
Labeler dr. reddy's labratories inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dofetilide .25 mg/1

Manufacturer
Dr. Reddy's Labratories Inc.

Identifiers & Regulatory

Product NDC 75907-055
Product ID 75907-055_861cea42-b727-d539-2e5d-aa7de6629fd4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207058
Listing Expiration 2026-12-31
Marketing Start 2024-05-28

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75907055
Hyphenated Format 75907-055

Supplemental Identifiers

RxCUI
310003 310004 310005
UPC
0375907056604
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 ANDA207058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (75907-055-60)
source: ndc

Packages (1)

75907-055-60 60 CAPSULE in 1 BOTTLE, PLASTIC (75907-055-60)

Ingredients (1)

dofetilide (.25 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": "861cea42-b727-d539-2e5d-aa7de6629fd4", "openfda": {"nui": ["N0000175426"], "upc": ["0375907056604"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["28fe0cac-62fd-997d-8065-561aaf1541c4"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Dr. Reddy's Labratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (75907-055-60)", "package_ndc": "75907-055-60", "marketing_start_date": "20240528"}], "brand_name": "Dofetilide", "product_id": "75907-055_861cea42-b727-d539-2e5d-aa7de6629fd4", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "75907-055", "generic_name": "Dofetilide", "labeler_name": "Dr. Reddy's Labratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dofetilide", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".25 mg/1"}], "application_number": "ANDA207058", "marketing_category": "ANDA", "marketing_start_date": "20240528", "listing_expiration_date": "20261231"}