Dofetilide

Product NDC: 70518-4617
11-digit product format: 705184617
Labeler code: 70518
Product ID: 70518-4617_503731c8-a13f-5769-e063-6394a90afbe7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dofetilide
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA213220
Marketing category: ANDA
Marketing start: 2026-04-24
Substance: DOFETILIDE
Active strength: .25 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Dofetilide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOFETILIDE	.25 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	R4Z9X1N2ND
Rxcui	310004

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cdc36b95-20ce-9079-16ec-f3cdb4dcf4fd	Product name	9	20230112

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4617-0	Dofetilide	50 in 1 BOX	CAPSULE	50		1
70518-4617-1	Dofetilide	1 in 1 POUCH	CAPSULE	1		1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310004	dofetilide 250 MCG Oral Capsule	PSN	a5d943c6-1960-4318-9e6f-6bf69ac49953	1
310004	dofetilide 0.25 MG Oral Capsule	SCD	a5d943c6-1960-4318-9e6f-6bf69ac49953	1
310004	dofetilide 250 MCG Oral Capsule	SY	a5d943c6-1960-4318-9e6f-6bf69ac49953	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4617-0	70518461700	50 POUCH in 1 BOX (70518-4617-0) / 1 CAPSULE in 1 POUCH (70518-4617-1)	50 pouch	2026-04-24	No	No	Historical
70518-4617-1	70518461701	1 in 1 POUCH					Historical