Dofetilide

Product NDC
0904-6681
11-digit product format
009046681
Labeler code
0904
Product ID
0904-6681_878263a5-b2a1-4aa0-84cc-7fc165ee86c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA207058
Marketing category
ANDA
Marketing start
2016-06-07
Marketing end
0000-00-00
Substance
DOFETILIDE
Active strength
0 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6681DOFETILIDE CAPSULE [MAJOR PHARMACEUTICALS]4Legacy NDC20250402_878263a5-b2a1-4aa0-84cc-7fc165ee86c9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6681-080090466810840 BLISTER PACK in 1 CARTON (0904-6681-08) > 1 CAPSULE in 1 BLISTER PACK40 blister pack2016-06-070000-00-00NoNoCurrent