FDA.reportPublic FDA data

Dofetilide

Product NDC
0904-6681
11-digit product format
009046681
Labeler code
0904
Product ID
0904-6681_878263a5-b2a1-4aa0-84cc-7fc165ee86c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA207058
Marketing category
ANDA
Marketing start
2016-06-07
Marketing end
0000-00-00
Substance
DOFETILIDE
Active strength
0 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct0904-6681DDiscontinued by firm2026-07-31
excluded packagepackage0904-66810904-6681-08DDiscontinued by firm2026-07-31

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
A207058-001DOFETILIDEDOFETILIDE0.125MGCAPSULE / ORALAB2016-06-06
A207058-002DOFETILIDEDOFETILIDE0.25MGCAPSULE / ORALAB2016-06-06
A207058-003DOFETILIDEDOFETILIDE0.5MGCAPSULE / ORALAB2016-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207058-001AB
A207058-002AB
A207058-003AB

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 22:54:322026-06A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-06a50c72e98297…
2026-08-01 22:54:322026-06A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-06a50c72e98297…
2026-08-01 22:54:322026-06A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207058-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A207058-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A207058-003AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DofetilideDOFETILIDEMajor Pharmaceuticals26de5f8c-8cec-46f6-a468-69451758a2782026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207058
application number: ANDA207058
DofetilideDOFETILIDEDr. Reddy's Labratories Inc.28fe0cac-62fd-997d-8065-561aaf1541c42024-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207058
application number: ANDA207058

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6681DOFETILIDE CAPSULE [MAJOR PHARMACEUTICALS]4Legacy NDC20250402_878263a5-b2a1-4aa0-84cc-7fc165ee86c9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6681-080090466810840 BLISTER PACK in 1 CARTON (0904-6681-08) > 1 CAPSULE in 1 BLISTER PACK40 blister pack2016-06-070000-00-00NoNoCurrent