dofetilide

Generic: dofetilide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dofetilide
Generic Name dofetilide
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dofetilide .125 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-061
Product ID 47335-061_3ea6a12b-26de-4858-aebe-4f8902cc560f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210466
Listing Expiration 2026-12-31
Marketing Start 2018-10-11

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335061
Hyphenated Format 47335-061

Supplemental Identifiers

RxCUI
310003 310004 310005
UPC
0347335062861 0347335061864
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
  • .125 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (47335-061-79) / 10 CAPSULE in 1 BLISTER PACK (47335-061-66)
  • 60 CAPSULE in 1 BOTTLE (47335-061-86)
source: ndc

Packages (2)

47335-061-79 4 BLISTER PACK in 1 CARTON (47335-061-79) / 10 CAPSULE in 1 BLISTER PACK (47335-061-66) 47335-061-86 60 CAPSULE in 1 BOTTLE (47335-061-86)

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": "3ea6a12b-26de-4858-aebe-4f8902cc560f", "openfda": {"nui": ["N0000175426"], "upc": ["0347335062861", "0347335061864"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["e6caaf44-4a3e-46ef-85fa-f97f682fbdd6"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (47335-061-79)  / 10 CAPSULE in 1 BLISTER PACK (47335-061-66)", "package_ndc": "47335-061-79", "marketing_start_date": "20181011"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (47335-061-86)", "package_ndc": "47335-061-86", "marketing_start_date": "20181011"}], "brand_name": "DOFETILIDE", "product_id": "47335-061_3ea6a12b-26de-4858-aebe-4f8902cc560f", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "47335-061", "generic_name": "DOFETILIDE", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOFETILIDE", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".125 mg/1"}], "application_number": "ANDA210466", "marketing_category": "ANDA", "marketing_start_date": "20181011", "listing_expiration_date": "20261231"}