Home NDC 42291-413 Dofetilide
Product NDC 42291-413
11-digit product format 422910413
Labeler code 42291
Product ID 42291-413_ec193314-9326-3010-e053-2a95a90aeb78
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA207746
Marketing category ANDA
Marketing start 2018-08-06
Marketing end 0000-00-00
Substance DOFETILIDE
Active strength 500 ug/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 4 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 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 42291-413 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42291-413 42291-413-60 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 42291-413 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42291-413 42291-413-60 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A207746-001 DOFETILIDE DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 A207746-002 DOFETILIDE DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 A207746-003 DOFETILIDE DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26
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 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 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 Dofetilide DOFETILIDE Sigmapharm Laboratories, LLC 0cb2ef7d-e35b-483b-9985-cfef99d7b96f 2023-01-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207746 application number: ANDA207746
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-413-60 42291041360 60 CAPSULE in 1 BOTTLE, PLASTIC (42291-413-60) 60 capsule 2018-08-06 0000-00-00 No No Current