Losartan Potassium

Product NDC
53002-2643
11-digit product format
530022643
Labeler code
53002
Product ID
53002-2643_87af9b03-c984-450f-a2dc-39da1776f2c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090467
Marketing category
ANDA
Marketing start
2010-10-06
Marketing end
0000-00-00
Substance
LOSARTAN POTASSIUM
Active strength
50 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-2643IInactivated by FDA2026-08-03
excluded packagepackage53002-264353002-2643-0IInactivated by FDA2026-08-03
excluded packagepackage53002-264353002-2643-3IInactivated by FDA2026-08-03
excluded packagepackage53002-264353002-2643-9IInactivated by FDA2026-08-03

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-2643-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-2643-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-2643-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-2643-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-2643-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-2643-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-2643-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-2643-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-2643-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-2643-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-2643-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-2643-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-2643-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-2643-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-2643-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-2643-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-2643-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-2643-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-2643-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-2643-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-2643-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-2643-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-2643-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-2643-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-2643-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-2643-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-2643-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53002-2643-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53002-2643-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53002-2643-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53002-2643-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53002-2643-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53002-2643-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53002-2643-9557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53002-2643-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53002-2643-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53002-2643-98af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53002-2643-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53002-2643-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53002-2643-9834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53002-2643-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53002-2643-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53002-2643-91332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53002-2643-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53002-2643-01332a3947898…d4bfe170f9cd…

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2643-0Losartan Potassium100 in 1 BOTTLETABLET1001
53002-2643-3Losartan Potassium30 in 1 BOTTLETABLET301
53002-2643-9Losartan Potassium90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2643LOSARTAN POTASSIUM TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20201225_f08333a1-35d7-446c-9ca2-41b2c4e533d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSNf08333a1-35d7-446c-9ca2-41b2c4e533d81
979492losartan potassium 50 MG Oral TabletSCDf08333a1-35d7-446c-9ca2-41b2c4e533d81
979492Losartan K+ 50 MG Oral TabletSYf08333a1-35d7-446c-9ca2-41b2c4e533d81
979492Losartan Pot 50 MG Oral TabletSYf08333a1-35d7-446c-9ca2-41b2c4e533d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2643-053002264300100 TABLET in 1 BOTTLE (53002-2643-0) 100 tablet2019-01-010000-00-00NoNoCurrent
53002-2643-35300226430330 TABLET in 1 BOTTLE (53002-2643-3) 30 tablet2019-01-010000-00-00NoNoCurrent
53002-2643-95300226430990 TABLET in 1 BOTTLE (53002-2643-9) 90 tablet2019-01-010000-00-00NoNoCurrent