Home NDC 69189-5800 Tikosyn
Product NDC 69189-5800
11-digit product format 691895800
Labeler code 69189
Product ID 69189-5800_e5f28d83-d575-4c10-af66-84c5535f98f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dofetilide
Dosage form CAPSULE
Route ORAL
Labeler Avera McKennan Hospital
Application NDA020931
Marketing category NDA
Marketing start 2016-06-28
Marketing end 0000-00-00
Substance DOFETILIDE
Active strength 0 mg/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 44 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 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69189-5800-1 I Inactivated by FDA 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 69189-5800-1 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 69189-5800-1 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 69189-5800-1 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 69189-5800-1 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 69189-5800-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69189-5800-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69189-5800-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69189-5800-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69189-5800-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69189-5800-1 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69189-5800-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69189-5800-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69189-5800-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69189-5800-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69189-5800-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69189-5800-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69189-5800-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 69189-5800-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 69189-5800-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 69189-5800-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 69189-5800-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 RLD / RS Approval date N020931-001 TIKOSYN DOFETILIDE 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 N020931-002 TIKOSYN DOFETILIDE 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 N020931-003 TIKOSYN DOFETILIDE 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69189-5800-1 Tikosyn 1 in 1 DOSE PACK CAPSULE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69189-5800 TIKOSYN (DOFETILIDE) CAPSULE [AVERA MCKENNAN HOSPITAL] 1 Legacy NDC, 1 package rows 20170410_37e125c9-cbcd-43a7-b1f8-81043ac1b721.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tikosyn DOFETILIDE Pfizer Laboratories Div Pfizer Inc 02438044-d6a3-49e9-a1ac-3aad21ef2c8c 2026-04-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020931 application number: NDA020931
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 69189-5800-1 69189580001 1 in 1 DOSE PACK Historical