Home NDC 76282-756 Dofetilide
Product NDC 76282-756
11-digit product format 762820756
Labeler code 76282
Product ID 76282-756_19f2a722-24ef-44f2-90e6-ec8df457baf6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler EXELAN PHARMACEUTICALS, INC.
Application ANDA212750
Marketing category ANDA
Marketing start 2024-11-01
Substance DOFETILIDE
Active strength .25 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 A212750-001 DOFETILIDE DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 A212750-002 DOFETILIDE DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 A212750-003 DOFETILIDE DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14
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 · 99 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 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 99 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.
Additional Listing Data#
Finished product Yes
Brand name base Dofetilide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOFETILIDE .25 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 76282-756-60 Dofetilide 60 in 1 BOTTLE CAPSULE 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76282-756 DOFETILIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 2 Current NDC, 1 package rows 20241115_41ccbb23-ae03-44bd-b438-0b0a8388d56b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76282-756-60 76282075660 60 CAPSULE in 1 BOTTLE (76282-756-60) 60 capsule 2024-11-01 No No Current