Home NDC 76282-757 Dofetilide
Product NDC 76282-757
11-digit product format 762820757
Labeler code 76282
Product ID 76282-757_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 .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 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.
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 2026-08-01 22:54:32 2026-06 A212750-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2021-10-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A212750-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2021-10-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A212750-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2021-10-14 a50c72e98297…
Observed Orange Book normalized TE history# 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 .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 76282-757-60 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 76282-757 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 76282-757-60 76282075760 60 CAPSULE in 1 BOTTLE (76282-757-60) 60 capsule 2024-11-01 No No Current