Home NDC 51862-005-60 Dofetilide
Product NDC 51862-005
Requested package NDC 51862-005-60
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# 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 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 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 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.
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
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 · 2 matching rows.
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