Dofetilide

Product NDC
16714-840
Requested package NDC
16714-840-01
11-digit product format
167140840
Labeler code
16714
Product ID
16714-840_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
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage16714-84016714-840-01DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207058-002DOFETILIDE0.25MGCAPSULE / ORALAB2016-06-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207058-003DOFETILIDE0.5MGCAPSULE / ORALAB2016-06-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207058-001DOFETILIDE0.125MGCAPSULE / ORALAB2016-06-068072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207058-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207058-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207058-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207058-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207058-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207058-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207058-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207058-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207058-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207058-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207058-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207058-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207058-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207058-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207058-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207058-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207058-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207058-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207058-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207058-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207058-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207058-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207058-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207058-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207058-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207058-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207058-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207058-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207058-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207058-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207058-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207058-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207058-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207058-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207058-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207058-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207058-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207058-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207058-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207058-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-840-01EA - Each16714-84041f290f5-e12c-420d-acd8-afcb9fc80e1512018-10-11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-840-011671408400160 CAPSULE in 1 BOTTLE, PLASTIC (16714-840-01) 60 capsule2018-06-180000-00-00NoNoCurrent