Home NDC 72205-039 Dofetilide
Product NDC 72205-039
11-digit product format 722050039
Labeler code 72205
Product ID 72205-039_feb8626e-9d88-4a06-919f-f8169a69814b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA213220
Marketing category ANDA
Marketing start 2020-06-12
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 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 · 111 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 2026-02-19 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213220-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2020-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213220-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2020-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213220-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2020-01-29 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
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 72205-039-11 Dofetilide 10 in 1 BLISTER PACK CAPSULE 10 2 72205-039-37 Dofetilide 4 in 1 CARTON CAPSULE 4 2 72205-039-60 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 72205-039 DOFETILIDE CAPSULE [NOVADOZ PHARMACEUTICALS LLC] 2 Current NDC, Legacy NDC, 3 package rows 20220731_b8323987-90fe-4e6c-a71c-76e3c501713c.zip
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 Marketing end Sample Exclude flag Status 72205-039-11 72205003911 10 in 1 BLISTER PACK Historical 72205-039-37 72205003937 4 BLISTER PACK in 1 CARTON (72205-039-37) / 10 CAPSULE in 1 BLISTER PACK (72205-039-11) 4 blister pack 2020-06-12 0000-00-00 No No Current 72205-039-60 72205003960 60 CAPSULE in 1 BOTTLE (72205-039-60) 60 capsule 2020-06-12 0000-00-00 No No Current