Losartan Potassium

Product NDC
53002-1624
11-digit product format
530021624
Labeler code
53002
Product ID
53002-1624_7621f5bd-3be0-46d5-90a7-9c10c5fc2107
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076958
Marketing category
ANDA
Marketing start
2010-04-06
Marketing end
0000-00-00
Substance
LOSARTAN POTASSIUM
Active strength
25 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 productproduct53002-1624IInactivated by FDA2026-08-17
excluded packagepackage53002-162453002-1624-0IInactivated by FDA2026-08-17
excluded packagepackage53002-162453002-1624-3IInactivated by FDA2026-08-17
excluded packagepackage53002-162453002-1624-9IInactivated by FDA2026-08-17

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 2 · 68 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 packagepackage53002-1624-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-1624-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-1624-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-1624-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-1624-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-1624-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-1624-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-1624-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-1624-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-1624-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-1624-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-1624-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-1624-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-1624-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-1624-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-1624-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-1624-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-1624-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-1624-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-1624-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-1624-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-1624-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-1624-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-1624-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-1624-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-1624-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-1624-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53002-1624-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53002-1624-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53002-1624-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53002-1624-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53002-1624-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53002-1624-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53002-1624-9557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53002-1624-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53002-1624-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53002-1624-98af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53002-1624-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53002-1624-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53002-1624-9834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53002-1624-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53002-1624-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53002-1624-91332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53002-1624-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53002-1624-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076958-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06
A076958-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06
A076958-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-061e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A076958-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076958-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076958-003AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53002-1624-02023-01-30These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995
53002-1624-32023-01-30These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995
53002-1624-92023-01-30These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995
53002-1624-02020-12-17These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995
53002-1624-32020-12-17These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995
53002-1624-92020-12-17These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995
53002-1624-02020-01-31These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995
53002-1624-32020-01-31These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995
53002-1624-92020-01-31These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM Tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1624-0Losartan Potassium100 in 1 BOTTLETABLET, FILM COATED1003
53002-1624-3Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED303
53002-1624-9Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1624LOSARTAN POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20201218_207881a6-cc87-49a5-8e8f-6266b0dba4e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN207881a6-cc87-49a5-8e8f-6266b0dba4e93
979485losartan potassium 25 MG Oral TabletSCD207881a6-cc87-49a5-8e8f-6266b0dba4e93
979485Losartan K+ 25 MG Oral TabletSY207881a6-cc87-49a5-8e8f-6266b0dba4e93
979485Losartan Pot 25 MG Oral TabletSY207881a6-cc87-49a5-8e8f-6266b0dba4e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1624-053002162400100 TABLET, FILM COATED in 1 BOTTLE (53002-1624-0) 2017-09-010000-00-00NoNoCurrent
53002-1624-35300216240330 TABLET, FILM COATED in 1 BOTTLE (53002-1624-3) 2017-09-010000-00-00NoNoCurrent
53002-1624-95300216240990 TABLET, FILM COATED in 1 BOTTLE (53002-1624-9) 2017-09-010000-00-00NoNoCurrent