Tikosyn

Product NDC
69189-5800
11-digit product format
691895800
Labeler code
69189
Product ID
69189-5800_e5f28d83-d575-4c10-af66-84c5535f98f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA020931
Marketing category
NDA
Marketing start
2016-06-28
Marketing end
0000-00-00
Substance
DOFETILIDE
Active strength
0 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc36b95-20ce-9079-16ec-f3cdb4dcf4fdProduct name920230112

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69189-5800-12020-01-31C16284748780-19d75b9d0-8368-f424-e053-dadaa90a57ceTIKOSYN ® (dofetilide) Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-5800-1Tikosyn1 in 1 DOSE PACKCAPSULE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-5800TIKOSYN (DOFETILIDE) CAPSULE [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170410_37e125c9-cbcd-43a7-b1f8-81043ac1b721.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310003dofetilide 125 MCG Oral CapsulePSN37e125c9-cbcd-43a7-b1f8-81043ac1b7211
284404Tikosyn 125 MCG Oral CapsulePSN37e125c9-cbcd-43a7-b1f8-81043ac1b7211
284404dofetilide 0.125 MG Oral Capsule [Tikosyn]SBD37e125c9-cbcd-43a7-b1f8-81043ac1b7211
310003dofetilide 0.125 MG Oral CapsuleSCD37e125c9-cbcd-43a7-b1f8-81043ac1b7211
310003dofetilide 125 MCG Oral CapsuleSY37e125c9-cbcd-43a7-b1f8-81043ac1b7211
284404Tikosyn 0.125 MG Oral CapsuleSY37e125c9-cbcd-43a7-b1f8-81043ac1b7211
284404Tikosyn 125 MCG Oral CapsuleSY37e125c9-cbcd-43a7-b1f8-81043ac1b7211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-5800-1691895800011 in 1 DOSE PACKHistorical