Dofetilide

Product NDC: 72664-229
11-digit product format: 726640229
Labeler code: 72664
Product ID: 72664-229_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: 0 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72664-229		I	Inactivated by FDA		2026-08-07
excluded package	package	72664-229	72664-229-60	I	Inactivated by FDA		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A215323-001	DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14
A215323-002	DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14
A215323-003	DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215323-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	2022-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215323-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	2022-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215323-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	2022-04-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215323-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215323-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215323-003	AB	1	`5c6f7cd8ea54…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215323-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215323-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215323-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215323-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215323-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215323-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215323-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A215323-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A215323-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215323-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215323-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215323-003	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72664-229-60	2026-01-29	C162847	48780-1	49896155-d4a7-586f-e063-e6dba90add90	Dofetilide Capsules Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72664-229-60	Dofetilide	60 in 1 BOTTLE	CAPSULE	60		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72664-229	DOFETILIDE CAPSULE [VGYAAN PHARMACEUTICALS LLC]	6	Legacy NDC, 1 package rows	20231005_9bea7ddd-681c-4be5-8cf4-2e2df462745a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R4Z9X1N2ND	DOFETILIDE	115256-11-6	DOFETILIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310003	dofetilide 125 MCG Oral Capsule	PSN	9bea7ddd-681c-4be5-8cf4-2e2df462745a	6
310004	dofetilide 250 MCG Oral Capsule	PSN	9bea7ddd-681c-4be5-8cf4-2e2df462745a	6
310005	dofetilide 500 MCG Oral Capsule	PSN	9bea7ddd-681c-4be5-8cf4-2e2df462745a	6
310003	dofetilide 0.125 MG Oral Capsule	SCD	9bea7ddd-681c-4be5-8cf4-2e2df462745a	6
310004	dofetilide 0.25 MG Oral Capsule	SCD	9bea7ddd-681c-4be5-8cf4-2e2df462745a	6
310005	dofetilide 0.5 MG Oral Capsule	SCD	9bea7ddd-681c-4be5-8cf4-2e2df462745a	6
310003	dofetilide 125 MCG Oral Capsule	SY	9bea7ddd-681c-4be5-8cf4-2e2df462745a	6
310004	dofetilide 250 MCG Oral Capsule	SY	9bea7ddd-681c-4be5-8cf4-2e2df462745a	6
310005	dofetilide 500 MCG Oral Capsule	SY	9bea7ddd-681c-4be5-8cf4-2e2df462745a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72664-229-60	72664022960	60 CAPSULE in 1 BOTTLE (72664-229-60)	60 capsule	2022-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dofetilide Capsules Rx only	VGYAAN Pharmaceuticals LLC	2023-10-04	HUMAN PRESCRIPTION DRUG LABEL	6