FDA.reportPublic FDA data

Dofetilide

Product NDC
42291-411
11-digit product format
422910411
Labeler code
42291
Product ID
42291-411_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
125 ug/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-411DDiscontinued by firm2026-08-03
excluded packagepackage42291-41142291-411-60DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207746-001DOFETILIDEDOFETILIDE0.125MGCAPSULE / ORALAB2018-03-26
A207746-002DOFETILIDEDOFETILIDE0.25MGCAPSULE / ORALAB2018-03-26
A207746-003DOFETILIDEDOFETILIDE0.5MGCAPSULE / ORALAB2018-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207746-001AB
A207746-002AB
A207746-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207746-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-03-26a50c72e98297…
2026-08-01 22:54:322026-06A207746-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-03-26a50c72e98297…
2026-08-01 22:54:322026-06A207746-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207746-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A207746-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A207746-003AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DofetilideDOFETILIDESigmapharm Laboratories, LLC0cb2ef7d-e35b-483b-9985-cfef99d7b96f2023-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207746
application number: ANDA207746

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-411-60EA - Each42291-4115ee4fecf-8cb1-439d-8382-08888ba7a8fc12018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-411-604229104116060 CAPSULE in 1 BOTTLE, PLASTIC (42291-411-60) 60 capsule2018-08-060000-00-00NoNoCurrent