Dofetilide

Product NDC: 70518-4738
Requested package NDC: 70518-4738-0
11-digit product format: 705184738
Labeler code: 70518
Product ID: 70518-4738_59f77ab6-e52a-9506-e063-6294a90aa720
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dofetilide
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA213220
Marketing category: ANDA
Marketing start: 2026-08-26
Substance: DOFETILIDE
Active strength: .125 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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.

Additional Listing Data#

Finished product: Yes
Brand name base: Dofetilide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOFETILIDE	.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R4Z9X1N2ND	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310003	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cff8d66a-ed43-46dd-97de-3dd21a7f2572	Available on FDA.report

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 ndc (package): 70518-4738-0 ndc (product): 70518-4738 ndc11 (package): 70518473800
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	Sample	Exclude flag	Status
70518-4738-0	70518473800	100 POUCH in 1 BOX (70518-4738-0) / 1 CAPSULE in 1 POUCH (70518-4738-2)	100 pouch	2026-08-26	No	No	Current