Home NDC 47335-062 DOFETILIDE
Product NDC 47335-062
11-digit product format 473350062
Labeler code 47335
Product ID 47335-062_3ea6a12b-26de-4858-aebe-4f8902cc560f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOFETILIDE
Dosage form CAPSULE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA210466
Marketing category ANDA
Marketing start 2018-10-11
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 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.
Product history page 1 of 4 · 123 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 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210466-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210466-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210466-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-10-09 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 .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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 47335-062-66 DOFETILIDE 10 in 1 BLISTER PACK CAPSULE 10 7 47335-062-79 DOFETILIDE 4 in 1 CARTON CAPSULE 4 7 47335-062-86 DOFETILIDE 60 in 1 BOTTLE CAPSULE 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-062 DOFETILIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20231102_e6caaf44-4a3e-46ef-85fa-f97f682fbdd6.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 47335-062-66 47335006266 10 in 1 BLISTER PACK Historical 47335-062-79 47335006279 4 BLISTER PACK in 1 CARTON (47335-062-79) / 10 CAPSULE in 1 BLISTER PACK (47335-062-66) 4 blister pack 2018-10-11 0000-00-00 No No Current 47335-062-86 47335006286 60 CAPSULE in 1 BOTTLE (47335-062-86) 60 capsule 2018-10-11 0000-00-00 No No Current