Dofetilide

Product NDC
72664-231
11-digit product format
726640231
Labeler code
72664
Product ID
72664-231_ddbd7d82-63d0-2f58-e053-2995a90aec10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
VGYAAN Pharmaceuticals LLC
Application
ANDA215323
Marketing category
ANDA
Marketing start
2022-10-25
Marketing end
0000-00-00
Substance
DOFETILIDE
Active strength
1 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
72664-231-602026-01-29C16284748780-149896155-d4a7-586f-e063-e6dba90add90Dofetilide Capsules Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72664-231-60Dofetilide60 in 1 BOTTLECAPSULE606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72664-231DOFETILIDE CAPSULE [VGYAAN PHARMACEUTICALS LLC]6Legacy NDC, 1 package rows20231005_9bea7ddd-681c-4be5-8cf4-2e2df462745a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310003dofetilide 125 MCG Oral CapsulePSN9bea7ddd-681c-4be5-8cf4-2e2df462745a6
310004dofetilide 250 MCG Oral CapsulePSN9bea7ddd-681c-4be5-8cf4-2e2df462745a6
310005dofetilide 500 MCG Oral CapsulePSN9bea7ddd-681c-4be5-8cf4-2e2df462745a6
310003dofetilide 0.125 MG Oral CapsuleSCD9bea7ddd-681c-4be5-8cf4-2e2df462745a6
310004dofetilide 0.25 MG Oral CapsuleSCD9bea7ddd-681c-4be5-8cf4-2e2df462745a6
310005dofetilide 0.5 MG Oral CapsuleSCD9bea7ddd-681c-4be5-8cf4-2e2df462745a6
310003dofetilide 125 MCG Oral CapsuleSY9bea7ddd-681c-4be5-8cf4-2e2df462745a6
310004dofetilide 250 MCG Oral CapsuleSY9bea7ddd-681c-4be5-8cf4-2e2df462745a6
310005dofetilide 500 MCG Oral CapsuleSY9bea7ddd-681c-4be5-8cf4-2e2df462745a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72664-231-607266402316060 CAPSULE in 1 BOTTLE (72664-231-60) 60 capsule2022-10-250000-00-00NoNoCurrent