Home NDC 42291-412-60 Dofetilide
Product NDC 42291-412
Requested package NDC 42291-412-60
11-digit product format 422910412
Labeler code 42291
Product ID 42291-412_ec193314-9326-3010-e053-2a95a90aeb78
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dofetilide
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA207746
Marketing category ANDA
Marketing start 2018-08-06
Marketing end 0000-00-00
Substance DOFETILIDE
Active strength 250 ug/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A207746-001 DOFETILIDE DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 A207746-002 DOFETILIDE DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 A207746-003 DOFETILIDE DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26
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 A207746-001 DOFETILIDE 0.125MG CAPSULE / ORAL AB 2018-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A207746-002 DOFETILIDE 0.25MG CAPSULE / ORAL AB 2018-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A207746-003 DOFETILIDE 0.5MG CAPSULE / ORAL AB 2018-03-26 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dofetilide DOFETILIDE Sigmapharm Laboratories, LLC 0cb2ef7d-e35b-483b-9985-cfef99d7b96f 2023-01-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207746 application number: ANDA207746
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-412-60 42291041260 60 CAPSULE in 1 BOTTLE, PLASTIC (42291-412-60) 60 capsule 2018-08-06 0000-00-00 No No Current