FDA.reportPublic FDA data

Dofetilide

Product NDC
72205-039
11-digit product format
722050039
Labeler code
72205
Product ID
72205-039_feb8626e-9d88-4a06-919f-f8169a69814b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA213220
Marketing category
ANDA
Marketing start
2020-06-12
Substance
DOFETILIDE
Active strength
.125 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.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR4Z9X1N2ND
Rxcui310003, 310004, 310005

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-039-11Dofetilide10 in 1 BLISTER PACKCAPSULE102
72205-039-37Dofetilide4 in 1 CARTONCAPSULE42
72205-039-60Dofetilide60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-039-60EA - Each72205-039b472e652-5898-41d3-bb42-b11a6363a60812020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-039DOFETILIDE CAPSULE [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 3 package rows20220731_b8323987-90fe-4e6c-a71c-76e3c501713c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310003dofetilide 125 MCG Oral CapsulePSNb8323987-90fe-4e6c-a71c-76e3c501713c2
310004dofetilide 250 MCG Oral CapsulePSNb8323987-90fe-4e6c-a71c-76e3c501713c2
310005dofetilide 500 MCG Oral CapsulePSNb8323987-90fe-4e6c-a71c-76e3c501713c2
310003dofetilide 0.125 MG Oral CapsuleSCDb8323987-90fe-4e6c-a71c-76e3c501713c2
310004dofetilide 0.25 MG Oral CapsuleSCDb8323987-90fe-4e6c-a71c-76e3c501713c2
310005dofetilide 0.5 MG Oral CapsuleSCDb8323987-90fe-4e6c-a71c-76e3c501713c2
310003dofetilide 125 MCG Oral CapsuleSYb8323987-90fe-4e6c-a71c-76e3c501713c2
310004dofetilide 250 MCG Oral CapsuleSYb8323987-90fe-4e6c-a71c-76e3c501713c2
310005dofetilide 500 MCG Oral CapsuleSYb8323987-90fe-4e6c-a71c-76e3c501713c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-039-117220500391110 in 1 BLISTER PACKHistorical
72205-039-37722050039374 BLISTER PACK in 1 CARTON (72205-039-37) / 10 CAPSULE in 1 BLISTER PACK (72205-039-11) 4 blister pack2020-06-120000-00-00NoNoCurrent
72205-039-607220500396060 CAPSULE in 1 BOTTLE (72205-039-60) 60 capsule2020-06-120000-00-00NoNoCurrent