Home NDC 42794-046 Dofetilide
Product NDC 42794-046
11-digit product format 427940046
Labeler code 42794
Product ID 42794-046_f1f1f93d-aee6-246f-e053-2a95a90a9eee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler Sigmapharm Laboratories, LLC
Application ANDA207746
Marketing category ANDA
Marketing start 2018-06-11
Substance DOFETILIDE
Active strength 500 ug/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 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.
Additional Listing Data#
Finished product Yes
Brand name base Dofetilide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOFETILIDE 500 ug/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 42794-046-10 Dofetilide 60 in 1 BOTTLE, PLASTIC CAPSULE 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42794-046 DOFETILIDE CAPSULE [SIGMAPHARM LABORATORIES, LLC] 7 Current NDC, Legacy NDC, 1 package rows 20230111_0cb2ef7d-e35b-483b-9985-cfef99d7b96f.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 · 1 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 42794-046-10 42794004610 60 CAPSULE in 1 BOTTLE, PLASTIC (42794-046-10) 60 capsule 2018-06-11 0000-00-00 No No Current