Dofetilide

Product NDC: 0904-6683
Requested package NDC: 0904-6683-08
11-digit product format: 009046683
Labeler code: 0904
Product ID: 0904-6683_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: 1 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	0904-6683	0904-6683-08	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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
0904-6683	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
0904-6683-08	00904668308	40 BLISTER PACK in 1 CARTON (0904-6683-08) > 1 CAPSULE in 1 BLISTER PACK	40 blister pack	2016-06-07	0000-00-00	No	No	Current