Home NDC 59762-0038-2 Dofetilide
Product NDC 59762-0038
Requested package NDC 59762-0038-2
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# 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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# 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
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