Home NDC 59762-0038 Dofetilide
Product NDC 59762-0038
11-digit product format 597620038
Labeler code 59762
Product ID 59762-0038_405dbc39-b8e9-4d2a-846a-c467b05e7298
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dofetilide
Dosage form CAPSULE
Route ORAL
Labeler Greenstone LLC
Application NDA020931
Marketing category NDA
Marketing start 2016-05-01
Marketing end 2021-03-31
Substance DOFETILIDE
Active strength 0 mg/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 24 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 59762-0038 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 59762-0038 59762-0038-2 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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.
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 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59762-0038-2 59762003802 60 CAPSULE in 1 BOTTLE (59762-0038-2) 60 capsule 2016-05-01 2021-03-31 No No Current