LOSARTAN POTASSIUM

Product NDC
50090-4252
Requested package NDC
50090-4252-0
11-digit product format
500904252
Labeler code
50090
Product ID
50090-4252_6e81770a-6a92-4c46-82f3-8fb3554ad377
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091541
Marketing category
ANDA
Marketing start
2012-12-06
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-425250090-4252-0IInactivated 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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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
A091541-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24
A091541-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24
A091541-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A091541-001AB
A091541-002AB
A091541-003AB

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 UTC2026-02A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-248072bd15b7f6…

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 UTC2026-02A091541-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091541-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091541-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091541-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091541-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091541-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091541-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091541-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091541-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091541-001AB18072bd15b7f6…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4252-0LOSARTAN POTASSIUM30 in 1 BOTTLETABLET, FILM COATED304
50090-4252-1LOSARTAN POTASSIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4252LOSARTAN POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20200225_d142e482-e562-48f1-b164-e8980eadb0b3.zip

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
LOSARTAN POTASSIUMLOSARTAN POTASSIUMBryant Ranch Prepackeace2965-c02b-49ec-aad8-3a69a6ae9cbf2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091541
application number: ANDA091541
LOSARTAN POTASSIUMLOSARTAN POTASSIUMMicro Labs Limitedf2f2b6c6-0ab1-483f-b4a2-78dfe32001532025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091541
application number: ANDA091541

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSNd142e482-e562-48f1-b164-e8980eadb0b34
979485losartan potassium 25 MG Oral TabletSCDd142e482-e562-48f1-b164-e8980eadb0b34
979485Losartan K+ 25 MG Oral TabletSYd142e482-e562-48f1-b164-e8980eadb0b34
979485Losartan Pot 25 MG Oral TabletSYd142e482-e562-48f1-b164-e8980eadb0b34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4252-05009042520030 TABLET, FILM COATED in 1 BOTTLE (50090-4252-0) 2019-04-050000-00-00NoNoCurrent