Home NDC 69452-132 Dofetilide
Product NDC 69452-132
11-digit product format 694520132
Labeler code 69452
Product ID 69452-132_f7811d48-6a19-d784-e053-6394a90aac27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler Bionpharma Inc.
Application ANDA208625
Marketing category ANDA
Marketing start 2018-04-11
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 A208625-001 DOFETILIDE DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-04-10 A208625-002 DOFETILIDE DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-04-10 A208625-003 DOFETILIDE DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-04-10
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 A208625-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-04-10 a50c72e98297…2026-08-01 22:54:32 2026-06 A208625-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-04-10 a50c72e98297…2026-08-01 22:54:32 2026-06 A208625-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-04-10 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 · 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 .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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69452-132-17 Dofetilide 60 in 1 BOTTLE CAPSULE 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-132 DOFETILIDE CAPSULE [BIONPHARMA INC.] 5 Current NDC, Legacy NDC, 1 package rows 20230323_0e60aa4b-72c2-4ef4-ab01-c9cf94240ff1.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 69452-132-17 69452013217 60 CAPSULE in 1 BOTTLE (69452-132-17) 60 capsule 2018-04-11 0000-00-00 No No Current