Dofetilide

Product NDC: 69539-132
11-digit product format: 695390132
Labeler code: 69539
Product ID: 69539-132_6c77ee89-1263-47a5-9782-2ef5a58d24ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dofetilide
Dosage form: CAPSULE
Route: ORAL
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA213220
Marketing category: ANDA
Marketing start: 2020-01-29
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#

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69539-132		D	Discontinued by firm	2026-10-05
excluded package	package	69539-132	69539-132-38	D	Discontinued by firm	2026-10-05
excluded package	package	69539-132	69539-132-60	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69539-132-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69539-132-38	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69539-132-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69539-132-38	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69539-132-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69539-132-38	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69539-132-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69539-132-38	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69539-132-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69539-132-38	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69539-132-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69539-132-38	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69539-132-38	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69539-132-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69539-132-38	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69539-132-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69539-132-38	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69539-132-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213220-001	DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29
A213220-002	DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29
A213220-003	DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213220-001	AB
A213220-002	AB
A213220-003	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 3 · 117 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
2026-09-14 22:38:34	2026-08	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213220-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2020-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213220-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2020-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213220-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2020-01-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213220-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213220-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213220-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213220-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213220-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213220-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213220-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213220-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213220-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213220-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213220-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213220-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213220-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213220-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213220-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213220-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213220-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213220-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213220-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213220-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213220-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213220-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213220-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213220-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213220-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213220-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213220-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213220-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213220-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213220-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213220-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213220-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213220-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213220-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213220-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213220-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213220-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213220-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213220-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213220-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69539-132-38	2025-11-26	Dofetilide Capsules
69539-132-60	2025-11-26	Dofetilide Capsules
69539-132-38	2025-01-30	Dofetilide Capsules
69539-132-60	2025-01-30	Dofetilide Capsules

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-132	DOFETILIDE CAPSULE [MSN LABORATORIES PRIVATE LIMITED]	2	Legacy NDC	20200212_1caa7d09-4d6c-4ccb-a44f-6f93a55fefe2.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dofetilide	DOFETILIDE	REMEDYREPACK INC.	cff8d66a-ed43-46dd-97de-3dd21a7f2572	2026-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213220 application number: ANDA213220
Dofetilide	DOFETILIDE	REMEDYREPACK INC.	a5d943c6-1960-4318-9e6f-6bf69ac49953	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213220 application number: ANDA213220
Dofetilide	DOFETILIDE	Novadoz Pharmaceuticals LLC	b8323987-90fe-4e6c-a71c-76e3c501713c	2022-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213220 application number: ANDA213220

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
69539-132-38	69539013238	4 BLISTER PACK in 1 CARTON (69539-132-38) > 10 CAPSULE in 1 BLISTER PACK (69539-132-11)	4 blister pack	2020-01-29	0000-00-00	No	No	Current
69539-132-60	69539013260	60 CAPSULE in 1 BOTTLE (69539-132-60)	60 capsule	2020-01-29	0000-00-00	No	No	Current