ibutilide fumarate

Generic: ibutilide fumarate

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibutilide fumarate
Generic Name ibutilide fumarate
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ibutilide fumarate 1 mg/10mL

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-326
Product ID 23155-326_d27fccf1-d015-47a7-9fff-2d028495a1fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204146
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155326
Hyphenated Format 23155-326

Supplemental Identifiers

RxCUI
979120
UPC
0323155326314
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 ANDA204146 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/10mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (23155-326-31) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

23155-326-31 1 VIAL, GLASS in 1 CARTON (23155-326-31) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

ibutilide fumarate (1 mg/10mL)

Linked Drug Pages (1)

Ibutilide Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d27fccf1-d015-47a7-9fff-2d028495a1fc", "openfda": {"upc": ["0323155326314"], "unii": ["9L5X4M5L6I"], "rxcui": ["979120"], "spl_set_id": ["0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd0"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (23155-326-31)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "23155-326-31", "marketing_start_date": "20240401"}], "brand_name": "Ibutilide Fumarate", "product_id": "23155-326_d27fccf1-d015-47a7-9fff-2d028495a1fc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "23155-326", "generic_name": "Ibutilide Fumarate", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibutilide Fumarate", "active_ingredients": [{"name": "IBUTILIDE FUMARATE", "strength": "1 mg/10mL"}], "application_number": "ANDA204146", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}