Home NDC 0904-7522 Dofetilide
Product NDC 0904-7522
11-digit product format 009047522
Labeler code 0904
Product ID 0904-7522_fa04423d-af73-45d4-bfba-d57d39a2e0b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA207058
Marketing category ANDA
Marketing start 2024-10-17
Marketing end 2027-01-31
Substance DOFETILIDE
Active strength .125 mg/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
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 A207058-001 DOFETILIDE DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 A207058-002 DOFETILIDE DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 A207058-003 DOFETILIDE DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06
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 A207058-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2016-06-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A207058-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2016-06-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A207058-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2016-06-06 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 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 0904-7522-08 Dofetilide 1 in 1 BLISTER PACK CAPSULE 1 3 0904-7522-08 Dofetilide 40 in 1 CARTON CAPSULE 40 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7522 DOFETILIDE CAPSULE [MAJOR PHARMACEUTICALS] 1 Current NDC, 2 package rows 20241020_26de5f8c-8cec-46f6-a468-69451758a278.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 0904-7522-08 00904752208 40 BLISTER PACK in 1 CARTON (0904-7522-08) / 1 CAPSULE in 1 BLISTER PACK 40 blister pack 2024-10-17 2027-01-31 No No Historical