ibutilide fumarate

Generic: ibutilide fumarate

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibutilide fumarate
Generic Name ibutilide fumarate
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ibutilide fumarate .1 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-366
Product ID 67457-366_88628540-e907-4411-8aa3-bc2a368e460d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090643
Marketing Start 2010-01-11
Marketing End 2026-03-31

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457366
Hyphenated Format 67457-366

Supplemental Identifiers

RxCUI
979120
UNII
9L5X4M5L6I

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 ibutilide fumarate (source: ndc)
Generic Name ibutilide fumarate (source: ndc)
Application Number ANDA090643 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (67457-366-10) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

67457-366-10 1 VIAL, GLASS in 1 CARTON (67457-366-10) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

ibutilide fumarate (.1 mg/mL)

Linked Drug Pages (1)

Ibutilide Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "88628540-e907-4411-8aa3-bc2a368e460d", "openfda": {"unii": ["9L5X4M5L6I"], "rxcui": ["979120"], "spl_set_id": ["c25d21e7-6136-4a7a-b139-12f53116fc3d"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (67457-366-10)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "67457-366-10", "marketing_end_date": "20260331", "marketing_start_date": "20100111"}], "brand_name": "Ibutilide Fumarate", "product_id": "67457-366_88628540-e907-4411-8aa3-bc2a368e460d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "67457-366", "generic_name": "Ibutilide Fumarate", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibutilide Fumarate", "active_ingredients": [{"name": "IBUTILIDE FUMARATE", "strength": ".1 mg/mL"}], "application_number": "ANDA090643", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20100111"}