Home NDC 16729-492 Dofetilide
Product NDC 16729-492
11-digit product format 167290492
Labeler code 16729
Product ID 16729-492_40bca241-47f2-b7f0-e063-6294a90a1680
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler Accord Healthcare, Inc.
Application ANDA213338
Marketing category ANDA
Marketing start 2020-08-20
Substance DOFETILIDE
Active strength .5 mg/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A213338-001 DOFETILIDE DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 A213338-002 DOFETILIDE DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 A213338-003 DOFETILIDE DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19
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 · 96 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 2025-01-19 17:59 UTC 2025-01 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 03ed91905a0d…2025-01-19 17:59 UTC 2025-01 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 03ed91905a0d…2025-01-19 17:59 UTC 2025-01 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213338-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-06-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213338-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213338-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-06-19 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 96 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.
Additional Listing Data#
Finished product Yes
Brand name base Dofetilide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOFETILIDE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R4Z9X1N2ND Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310003 Internal RxNorm lookup 310004 Internal RxNorm lookup 310005 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16729-492-12 Dofetilide 60 in 1 BOTTLE CAPSULE 60 7 16729-492-59 Dofetilide 180 in 1 BOTTLE CAPSULE 180 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-492 DOFETILIDE CAPSULE [ACCORD HEALTHCARE, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20241122_4c1a5a6d-bd69-473c-8caa-d0d242b7708d.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 16729-492-12 16729049212 60 CAPSULE in 1 BOTTLE (16729-492-12) 60 capsule 2020-08-20 0000-00-00 No No Current 16729-492-59 16729049259 180 in 1 BOTTLE Historical