tikosyn

Generic: dofetilide

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tikosyn
Generic Name dofetilide
Labeler pfizer laboratories div pfizer inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dofetilide .5 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-5820
Product ID 0069-5820_44ca2ecb-252d-4880-8a4f-6e47f5bdd734
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020931
Listing Expiration 2026-12-31
Marketing Start 1999-10-01

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00695820
Hyphenated Format 0069-5820

Supplemental Identifiers

RxCUI
284404 284405 285016 310003 310004 310005
UPC
0300695810602 0300695800603 0300695820601
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 tikosyn (source: ndc)
Generic Name dofetilide (source: ndc)
Application Number NDA020931 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (0069-5820-60)
  • 14 CAPSULE in 1 BOTTLE (0069-5820-61)
source: ndc

Packages (2)

0069-5820-60 60 CAPSULE in 1 BOTTLE (0069-5820-60) 0069-5820-61 14 CAPSULE in 1 BOTTLE (0069-5820-61)

Ingredients (1)

dofetilide (.5 mg/1)

Linked Drug Pages (1)

Tikosyn ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44ca2ecb-252d-4880-8a4f-6e47f5bdd734", "openfda": {"nui": ["N0000175426"], "upc": ["0300695810602", "0300695800603", "0300695820601"], "unii": ["R4Z9X1N2ND"], "rxcui": ["284404", "284405", "285016", "310003", "310004", "310005"], "spl_set_id": ["02438044-d6a3-49e9-a1ac-3aad21ef2c8c"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (0069-5820-60)", "package_ndc": "0069-5820-60", "marketing_start_date": "19991001"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (0069-5820-61)", "package_ndc": "0069-5820-61", "marketing_start_date": "19991001"}], "brand_name": "Tikosyn", "product_id": "0069-5820_44ca2ecb-252d-4880-8a4f-6e47f5bdd734", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "0069-5820", "generic_name": "dofetilide", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tikosyn", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".5 mg/1"}], "application_number": "NDA020931", "marketing_category": "NDA", "marketing_start_date": "19991001", "listing_expiration_date": "20261231"}