Losartan Potassium

Product NDC
50090-5626
11-digit product format
500905626
Labeler code
50090
Product ID
50090-5626_37a55ac8-2482-4979-8992-de8108d1b129
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078232
Marketing category
ANDA
Marketing start
2017-11-01
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
2026-12-31
Current FDA listing
Yes

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
A078232-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06
A078232-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06
A078232-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078232-001AB
A078232-002AB
A078232-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078232-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078232-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078232-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-061e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078232-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078232-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078232-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078232-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078232-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078232-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078232-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078232-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078232-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078232-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078232-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078232-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078232-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078232-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078232-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078232-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078232-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078232-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078232-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078232-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078232-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078232-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078232-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078232-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078232-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078232-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078232-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078232-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078232-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078232-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078232-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078232-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078232-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078232-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078232-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078232-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078232-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078232-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078232-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078232-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ST302B24AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979485Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a945396-dd71-4b16-bfab-947982407f36Available on FDA.report

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
50090-5626-0Losartan Potassium30 in 1 BOTTLETABLET307
50090-5626-1Losartan Potassium90 in 1 BOTTLETABLET907
50090-5626-2Losartan Potassium100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5626-0EA - Each50090-56268af4d83c-721b-4bd5-bd41-2a5f6c3b805b12022-06-06
50090-5626-1EA - Each50090-5626498dd9f8-127e-4f2c-81f8-101c4b1934d712022-06-06
50090-5626-2EA - Each50090-5626183fc350-4cb3-4ced-a1d9-de7208ef891a12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5626LOSARTAN POTASSIUM TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 3 package rows20241017_7a945396-dd71-4b16-bfab-947982407f36.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.c43e9dc6-2c8a-47d7-b40d-eb55dfe11a512026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078232
application number: ANDA078232
Losartan PotassiumLOSARTAN POTASSIUMLupin Pharmaceuticals, Inc.e5886220-43b7-46e1-9034-5242ba245bd12026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078232
application number: ANDA078232
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions7a945396-dd71-4b16-bfab-947982407f362024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078232
application number: ANDA078232
ndc (product): 50090-5626
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions679be0b9-bb60-4970-ad50-0041a6d67bf82023-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078232
application number: ANDA078232
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions0e0a06f3-b8bd-4178-a519-ed80362e33c22023-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078232
application number: ANDA078232

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN7a945396-dd71-4b16-bfab-947982407f367
979485losartan potassium 25 MG Oral TabletSCD7a945396-dd71-4b16-bfab-947982407f367
979485Losartan K+ 25 MG Oral TabletSY7a945396-dd71-4b16-bfab-947982407f367
979485Losartan Pot 25 MG Oral TabletSY7a945396-dd71-4b16-bfab-947982407f367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5626-05009056260030 TABLET in 1 BOTTLE (50090-5626-0) 30 tablet2021-09-010000-00-00NoNoCurrent
50090-5626-15009056260190 TABLET in 1 BOTTLE (50090-5626-1) 90 tablet2021-09-010000-00-00NoNoCurrent
50090-5626-250090562602100 TABLET in 1 BOTTLE (50090-5626-2) 100 tablet2023-03-09NoNoCurrent