Tikosyn

Product NDC
69189-5810
11-digit product format
691895810
Labeler code
69189
Product ID
69189-5810_bfb83f6b-8256-4ea0-84db-dc093b7b8139
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA020931
Marketing category
NDA
Marketing start
2016-07-29
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
69189-5810-12020-01-31C16284748780-19d75b9d0-da7d-f424-e053-dadaa90a57ceTIKOSYN ® (dofetilide) Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-5810-1Tikosyn1 in 1 DOSE PACKCAPSULE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-5810TIKOSYN (DOFETILIDE) CAPSULE [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170410_01f9fb69-2438-481c-b5ec-adebe7825253.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310004dofetilide 250 MCG Oral CapsulePSN01f9fb69-2438-481c-b5ec-adebe78252531
284405Tikosyn 250 MCG Oral CapsulePSN01f9fb69-2438-481c-b5ec-adebe78252531
284405dofetilide 0.25 MG Oral Capsule [Tikosyn]SBD01f9fb69-2438-481c-b5ec-adebe78252531
310004dofetilide 0.25 MG Oral CapsuleSCD01f9fb69-2438-481c-b5ec-adebe78252531
310004dofetilide 250 MCG Oral CapsuleSY01f9fb69-2438-481c-b5ec-adebe78252531
284405Tikosyn 0.25 MG Oral CapsuleSY01f9fb69-2438-481c-b5ec-adebe78252531
284405Tikosyn 250 MCG Oral CapsuleSY01f9fb69-2438-481c-b5ec-adebe78252531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-5810-1691895810011 in 1 DOSE PACKHistorical