FDA.reportPublic FDA data

Losartan Potassium

Product NDC
0615-8209
Requested package NDC
0615-8209-39
11-digit product format
006158209
Labeler code
0615
Product ID
0615-8209_4b1f2d99-a521-46c1-a96e-b66ceef54687
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA090467
Marketing category
ANDA
Marketing start
2010-10-06
Marketing end
2021-05-31
Substance
LOSARTAN POTASSIUM
Active strength
100 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage0615-82090615-8209-39DDiscontinued 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
A090467-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06
A090467-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06
A090467-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06

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 UTC2026-02A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-068072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090467-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090467-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090467-003AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A090467-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090467-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090467-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090467-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090467-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090467-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090467-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090467-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090467-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090467-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090467-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090467-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090467-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090467-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090467-003AB1ea99ee380514…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8209-390061582093930 TABLET in 1 BLISTER PACK (0615-8209-39) 30 tablet2018-04-062021-05-31NoNoCurrent