Home NDC 72603-130 DOFETILIDE
Product NDC 72603-130
11-digit product format 726030130
Labeler code 72603
Product ID 72603-130_d9cc5e83-13c7-40a5-86d3-29216f7f55fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOFETILIDE
Dosage form CAPSULE
Route ORAL
Labeler NorthStar RxLLC
Application ANDA210466
Marketing category ANDA
Marketing start 2023-02-07
Substance DOFETILIDE
Active strength .125 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 A210466-001 DOFETILIDE DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 A210466-002 DOFETILIDE DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 A210466-003 DOFETILIDE DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09
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 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 a50c72e98297…2026-08-01 22:54:32 2026-06 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 a50c72e98297…2026-08-01 22:54:32 2026-06 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 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 .125 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 72603-130-01 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 72603-130 DOFETILIDE CAPSULE [NORTHSTAR RXLLC] 2 Current NDC, 1 package rows 20231109_4552d82a-dd28-410c-9642-1af060832b47.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 72603-130-01 72603013001 60 CAPSULE in 1 BOTTLE (72603-130-01) 60 capsule 2023-02-07 No No Current