Home NDC 70518-4617 Dofetilide
Product NDC 70518-4617
11-digit product format 705184617
Labeler code 70518
Product ID 70518-4617_503731c8-a13f-5769-e063-6394a90afbe7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA213220
Marketing category ANDA
Marketing start 2026-04-24
Substance DOFETILIDE
Active strength .25 mg/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A213220-001 DOFETILIDE DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 A213220-002 DOFETILIDE DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 A213220-003 DOFETILIDE DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29
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 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 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 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310004 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 70518-4617-0 Dofetilide 50 in 1 BOX CAPSULE 50 1 70518-4617-1 Dofetilide 1 in 1 POUCH CAPSULE 1 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4617-0 70518461700 50 POUCH in 1 BOX (70518-4617-0) / 1 CAPSULE in 1 POUCH (70518-4617-1) 50 pouch 2026-04-24 No No Current 70518-4617-1 70518461701 1 in 1 POUCH Historical