Home NDC 51862-005 Dofetilide
Product NDC 51862-005
11-digit product format 518620005
Labeler code 51862
Product ID 51862-005_35cc8a01-96fa-43ab-8429-72396c201edd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler Mayne Pharma Inc.
Application ANDA207058
Marketing category ANDA
Marketing start 2016-06-07
Marketing end 0000-00-00
Substance DOFETILIDE
Active strength 1 mg/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 · 8 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 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 51862-005 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 51862-005 51862-005-60 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 51862-005 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 51862-005 51862-005-60 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 51862-005 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 51862-005 51862-005-60 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 51862-005 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 51862-005 51862-005-60 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A207058-001 DOFETILIDE DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 A207058-002 DOFETILIDE DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 A207058-003 DOFETILIDE DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06
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 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 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 · 2 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51862-005 DOFETILIDE CAPSULE [MAYNE PHARMA INC.] 7 Legacy NDC 20241004_a806d3d2-d4c1-461c-b2e4-8807bfb59cb8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51862-005-60 51862000560 60 CAPSULE in 1 BOTTLE, PLASTIC (51862-005-60) 60 capsule 2016-06-07 0000-00-00 No No Current