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 42 .
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.
Product history page 1 of 3 · 114 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 2026-08-18 06:07:40 2026-07 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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