Home NDC 69539-131-38 Dofetilide
Product NDC 69539-131
Requested package NDC 69539-131-38
11-digit product format 695390131
Labeler code 69539
Product ID 69539-131_6c77ee89-1263-47a5-9782-2ef5a58d24ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler MSN LABORATORIES PRIVATE LIMITED
Application ANDA213220
Marketing category ANDA
Marketing start 2020-01-29
Marketing end 0000-00-00
Substance DOFETILIDE
Active strength 0 mg/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 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 A213220-001 DOFETILIDE DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 A213220-002 DOFETILIDE DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 A213220-003 DOFETILIDE DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29
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 3 · 111 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 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69539-131 DOFETILIDE CAPSULE [MSN LABORATORIES PRIVATE LIMITED] 2 Legacy NDC 20200212_1caa7d09-4d6c-4ccb-a44f-6f93a55fefe2.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69539-131-38 69539013138 4 BLISTER PACK in 1 CARTON (69539-131-38) > 10 CAPSULE in 1 BLISTER PACK (69539-131-11) 4 blister pack 2020-01-29 0000-00-00 No No Current