Dofetilide

Product NDC: 42291-411
Requested package NDC: 42291-411-60
11-digit product format: 422910411
Labeler code: 42291
Product ID: 42291-411_ec193314-9326-3010-e053-2a95a90aeb78
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dofetilide
Dosage form: CAPSULE
Route: ORAL
Labeler: AvKARE
Application: ANDA207746
Marketing category: ANDA
Marketing start: 2018-08-06
Marketing end: 0000-00-00
Substance: DOFETILIDE
Active strength: 125 ug/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#

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	42291-411	42291-411-60	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
A207746-001	DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26
A207746-002	DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26
A207746-003	DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207746-001	AB
A207746-002	AB
A207746-003	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 2 · 63 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
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207746-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-03-26	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207746-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-03-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207746-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-03-26	`3f0d92c62455…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207746-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207746-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207746-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207746-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207746-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207746-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207746-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207746-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207746-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207746-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207746-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207746-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207746-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207746-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207746-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207746-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207746-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207746-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207746-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207746-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207746-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207746-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207746-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207746-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207746-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207746-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207746-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207746-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207746-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207746-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207746-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207746-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207746-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207746-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207746-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207746-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207746-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207746-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207746-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207746-001	AB	1	`3f0d92c62455…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dofetilide	DOFETILIDE	Sigmapharm Laboratories, LLC	0cb2ef7d-e35b-483b-9985-cfef99d7b96f	2023-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207746 application number: ANDA207746

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-411-60	EA - Each	42291-411	5ee4fecf-8cb1-439d-8382-08888ba7a8fc	1	2018-09-05

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
42291-411-60	42291041160	60 CAPSULE in 1 BOTTLE, PLASTIC (42291-411-60)	60 capsule	2018-08-06	0000-00-00	No	No	Current