Ibutilide Fumarate

Product NDC
67457-366
11-digit product format
674570366
Labeler code
67457
Product ID
67457-366_da9da185-9768-4032-b29f-064320c1ca81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibutilide Fumarate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA090643
Marketing category
ANDA
Marketing start
2010-01-11
Marketing end
0000-00-00
Substance
IBUTILIDE FUMARATE
Active strength
0 mg/mL
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-366-10ML - Milliliter67457-3663aa5a056-2cef-42bc-8df5-10715a0ea4d312012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-366IBUTILIDE FUMARATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]10Legacy NDC20250104_c25d21e7-6136-4a7a-b139-12f53116fc3d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-366-10674570366101 VIAL, GLASS in 1 CARTON (67457-366-10) > 10 mL in 1 VIAL, GLASS2010-01-110000-00-00NoNoCurrent