dofetilide 0.125mg (70010-024)

Drug Facts

Product Profile

Brand Name dofetilide 0.125mg

Generic Name dofetilide 0.125mg

Labeler granules pharmaceuticals inc.

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

dofetilide .125 mg/1

Manufacturer

Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-024

Product ID 70010-024_44f3f63d-4521-91e4-e063-6394a90a6d1b

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212750

Listing Expiration 2026-12-31

Marketing Start 2024-11-14

Pharmacologic Class

Established (EPC)

antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010024

Hyphenated Format 70010-024

Supplemental Identifiers

RxCUI

310003 310004 310005

UPC

0370010025066 0370010026063

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 0.125mg (source: ndc)

Generic Name dofetilide 0.125mg (source: ndc)

Application Number ANDA212750 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.125 mg/1

source: ndc

Packaging

60 CAPSULE in 1 BOTTLE (70010-024-06)

source: ndc

Packages (1)

70010-024-06 60 CAPSULE in 1 BOTTLE (70010-024-06)

Ingredients (1)

dofetilide (.125 mg/1)

Linked Drug Pages (1)

Dofetilide 0.125mg, Dofetilide 0.25mg, Dofetilide 0.5mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "44f3f63d-4521-91e4-e063-6394a90a6d1b", "openfda": {"nui": ["N0000175426"], "upc": ["0370010025066", "0370010026063"], "unii": ["R4Z9X1N2ND"], "rxcui": ["310003", "310004", "310005"], "spl_set_id": ["a10633a6-4518-4a87-a880-faaa33bdbec6"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (70010-024-06)", "package_ndc": "70010-024-06", "marketing_start_date": "20241114"}], "brand_name": "Dofetilide 0.125mg", "product_id": "70010-024_44f3f63d-4521-91e4-e063-6394a90a6d1b", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "70010-024", "generic_name": "Dofetilide 0.125mg", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dofetilide 0.125mg", "active_ingredients": [{"name": "DOFETILIDE", "strength": ".125 mg/1"}], "application_number": "ANDA212750", "marketing_category": "ANDA", "marketing_start_date": "20241114", "listing_expiration_date": "20261231"}