FDA.reportPublic FDA data

Dofetilide

Product NDC
16714-842
11-digit product format
167140842
Labeler code
16714
Product ID
16714-842_c8bb2a18-e47e-4e85-a052-85b06cd221e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA207058
Marketing category
ANDA
Marketing start
2018-06-18
Marketing end
0000-00-00
Substance
DOFETILIDE
Active strength
1 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 productproduct16714-842DDiscontinued by firm2026-07-31
excluded packagepackage16714-84216714-842-01DDiscontinued 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-842-01EA - Each16714-842fbb2717a-8d4c-4643-b7e2-f3b7c43ee95d12018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-842-011671408420160 CAPSULE in 1 BOTTLE, PLASTIC (16714-842-01) 60 capsule2018-06-180000-00-00NoNoCurrent