FDA.reportPublic FDA data

Dofetilide

Product NDC
75907-055
11-digit product format
759070055
Labeler code
75907
Product ID
75907-055_861cea42-b727-d539-2e5d-aa7de6629fd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Labratories Inc.
Application
ANDA207058
Marketing category
ANDA
Marketing start
2024-05-28
Substance
DOFETILIDE
Active strength
.25 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.25 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
75907-055-60Dofetilide60 in 1 BOTTLE, PLASTICCAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-055-60EA - Each75907-05579575250-a0d9-4b6e-b3a3-f4314089cdc912024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-055DOFETILIDE CAPSULE [DR. REDDY'S LABRATORIES INC.]1Current NDC, 1 package rows20240528_28fe0cac-62fd-997d-8065-561aaf1541c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310003dofetilide 125 MCG Oral CapsulePSN26de5f8c-8cec-46f6-a468-69451758a2783
310004dofetilide 250 MCG Oral CapsulePSN26de5f8c-8cec-46f6-a468-69451758a2783
310005dofetilide 500 MCG Oral CapsulePSN26de5f8c-8cec-46f6-a468-69451758a2783
310003dofetilide 0.125 MG Oral CapsuleSCD26de5f8c-8cec-46f6-a468-69451758a2783
310004dofetilide 0.25 MG Oral CapsuleSCD26de5f8c-8cec-46f6-a468-69451758a2783
310005dofetilide 0.5 MG Oral CapsuleSCD26de5f8c-8cec-46f6-a468-69451758a2783
310003dofetilide 125 MCG Oral CapsuleSY26de5f8c-8cec-46f6-a468-69451758a2783
310004dofetilide 250 MCG Oral CapsuleSY26de5f8c-8cec-46f6-a468-69451758a2783
310005dofetilide 500 MCG Oral CapsuleSY26de5f8c-8cec-46f6-a468-69451758a2783
310003dofetilide 125 MCG Oral CapsulePSN28fe0cac-62fd-997d-8065-561aaf1541c41
310004dofetilide 250 MCG Oral CapsulePSN28fe0cac-62fd-997d-8065-561aaf1541c41
310005dofetilide 500 MCG Oral CapsulePSN28fe0cac-62fd-997d-8065-561aaf1541c41
310003dofetilide 0.125 MG Oral CapsuleSCD28fe0cac-62fd-997d-8065-561aaf1541c41
310004dofetilide 0.25 MG Oral CapsuleSCD28fe0cac-62fd-997d-8065-561aaf1541c41
310005dofetilide 0.5 MG Oral CapsuleSCD28fe0cac-62fd-997d-8065-561aaf1541c41
310003dofetilide 125 MCG Oral CapsuleSY28fe0cac-62fd-997d-8065-561aaf1541c41
310004dofetilide 250 MCG Oral CapsuleSY28fe0cac-62fd-997d-8065-561aaf1541c41
310005dofetilide 500 MCG Oral CapsuleSY28fe0cac-62fd-997d-8065-561aaf1541c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-055-607590700556060 CAPSULE in 1 BOTTLE, PLASTIC (75907-055-60) 60 capsule2024-05-28NoNoCurrent