NDC 67457-366

Ibutilide Fumarate

Ibutilide Fumarate

Ibutilide Fumarate is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Ibutilide Fumarate.

• Product ID: 67457-366_0c944076-d483-4b7b-82a6-ea22d5630684
• NDC: 67457-366
• Product Type: Human Prescription Drug
• Proprietary Name: Ibutilide Fumarate
• Generic Name: Ibutilide Fumarate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-01-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090643
• Labeler Name: Mylan Institutional LLC
• Substance Name: IBUTILIDE FUMARATE
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Antiarrhythmic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 67457-366-10

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

• Marketing Start Date: 2010-01-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-366-10 [67457036610]

Ibutilide Fumarate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090643
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-01-11

Drug Details

Active Ingredients

Ingredient	Strength
IBUTILIDE FUMARATE	.1 mg/mL

OpenFDA Data

• SPL SET ID: c25d21e7-6136-4a7a-b139-12f53116fc3d
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • 9L5X4M5L6I
• RxNorm Concept Unique ID - RxCUI:
  • 979120

Pharmacological Class

• Antiarrhythmic [EPC]
• Antiarrhythmic [EPC]

NDC Crossover Matching brand name "Ibutilide Fumarate" or generic name "Ibutilide Fumarate"

NDC	Brand Name	Generic Name
67457-366	Ibutilide Fumarate	Ibutilide Fumarate
0009-3794	Corvert	ibutilide fumarate