Dofetilide

Product NDC: 0904-6682
Requested package NDC: 0904-6682-08
11-digit product format: 009046682
Labeler code: 0904
Product ID: 0904-6682_878263a5-b2a1-4aa0-84cc-7fc165ee86c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dofetilide
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA207058
Marketing category: ANDA
Marketing start: 2016-06-07
Marketing end: 0000-00-00
Substance: DOFETILIDE
Active strength: 0 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-6682	0904-6682-08	D	Discontinued by firm		2026-08-03

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	TE codes	Approval date
A207058-001	DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06
A207058-002	DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06
A207058-003	DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207058-001	AB
A207058-002	AB
A207058-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207058-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2016-06-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207058-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2016-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207058-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2016-06-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207058-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207058-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207058-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207058-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207058-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207058-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207058-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207058-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207058-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207058-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207058-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207058-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207058-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207058-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207058-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207058-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207058-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207058-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207058-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207058-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207058-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207058-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207058-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207058-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207058-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207058-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207058-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207058-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207058-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207058-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207058-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207058-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207058-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207058-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207058-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207058-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207058-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207058-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207058-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207058-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dofetilide	DOFETILIDE	Major Pharmaceuticals	26de5f8c-8cec-46f6-a468-69451758a278	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207058 application number: ANDA207058
Dofetilide	DOFETILIDE	Dr. Reddy's Labratories Inc.	28fe0cac-62fd-997d-8065-561aaf1541c4	2024-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207058 application number: ANDA207058

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6682	DOFETILIDE CAPSULE [MAJOR PHARMACEUTICALS]	4	Legacy NDC	20250402_878263a5-b2a1-4aa0-84cc-7fc165ee86c9.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6682-08	00904668208	40 BLISTER PACK in 1 CARTON (0904-6682-08) > 1 CAPSULE in 1 BLISTER PACK	40 blister pack	2016-06-07	0000-00-00	No	No	Current