DOFETILIDE

Product NDC
72603-132
11-digit product format
726030132
Labeler code
72603
Product ID
72603-132_d9cc5e83-13c7-40a5-86d3-29216f7f55fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOFETILIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA210466
Marketing category
ANDA
Marketing start
2023-02-07
Substance
DOFETILIDE
Active strength
.5 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOFETILIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOFETILIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR4Z9X1N2ND
Rxcui310003, 310004, 310005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
cdc36b95-20ce-9079-16ec-f3cdb4dcf4fdProduct name920230112

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-132-01DOFETILIDE60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-132-01EA - Each72603-132bf99821b-445a-495a-a21b-8925e4870b0712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-132DOFETILIDE CAPSULE [NORTHSTAR RXLLC]2Current NDC, 1 package rows20231109_4552d82a-dd28-410c-9642-1af060832b47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310003dofetilide 125 MCG Oral CapsulePSN4552d82a-dd28-410c-9642-1af060832b472
310004dofetilide 250 MCG Oral CapsulePSN4552d82a-dd28-410c-9642-1af060832b472
310005dofetilide 500 MCG Oral CapsulePSN4552d82a-dd28-410c-9642-1af060832b472
310003dofetilide 0.125 MG Oral CapsuleSCD4552d82a-dd28-410c-9642-1af060832b472
310004dofetilide 0.25 MG Oral CapsuleSCD4552d82a-dd28-410c-9642-1af060832b472
310005dofetilide 0.5 MG Oral CapsuleSCD4552d82a-dd28-410c-9642-1af060832b472
310003dofetilide 125 MCG Oral CapsuleSY4552d82a-dd28-410c-9642-1af060832b472
310004dofetilide 250 MCG Oral CapsuleSY4552d82a-dd28-410c-9642-1af060832b472
310005dofetilide 500 MCG Oral CapsuleSY4552d82a-dd28-410c-9642-1af060832b472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-132-017260301320160 CAPSULE in 1 BOTTLE (72603-132-01) 60 capsule2023-02-07NoNoCurrent