FDA.reportPublic FDA data

Losartan Potassium

Product NDC
43547-361
11-digit product format
435470361
Labeler code
43547
Product ID
43547-361_098aef71-90f1-40ee-b574-03dcbbad51a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA091497
Marketing category
ANDA
Marketing start
2022-03-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A
Rxcui979480, 979485, 979492

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43547-361-032020-04-23C16284748780-19d75b9d0-f325-f424-e053-dadaa90a57ceThese 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
43547-361-092020-04-23C16284748780-19d75b9d0-f325-f424-e053-dadaa90a57ceThese 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
43547-361-112020-04-23C16284748780-19d75b9d0-f325-f424-e053-dadaa90a57ceThese 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
43547-361-502020-04-23C16284748780-19d75b9d0-f325-f424-e053-dadaa90a57ceThese 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
43547-361-032020-01-31C16284748780-19d75b9d0-f325-f424-e053-dadaa90a57ceThese 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
43547-361-092020-01-31C16284748780-19d75b9d0-f325-f424-e053-dadaa90a57ceThese 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
43547-361-112020-01-31C16284748780-19d75b9d0-f325-f424-e053-dadaa90a57ceThese 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
43547-361-502020-01-31C16284748780-19d75b9d0-f325-f424-e053-dadaa90a57ceThese 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
43547-361-03Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED3018
43547-361-09Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED9018
43547-361-11Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED100018
43547-361-50Losartan Potassium500 in 1 BOTTLETABLET, FILM COATED50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-361-03EA - Each43547-36193f32d92-ff6a-4dd6-9adc-fb53e81b42fa12015-06-09
43547-361-09EA - Each43547-36190173ca2-6a5d-43c7-83b3-0ad440dbba1512015-06-09
43547-361-11EA - Each43547-3611fd5061c-d519-4bb8-8787-1b7dcbe1d6f112015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]9
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-361LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]16Current NDC, Legacy NDC, 4 package rows20240817_fa0cf2c2-6238-4edd-94e2-b670b98a0da4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979485losartan potassium 25 MG Oral TabletPSNfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979492losartan potassium 50 MG Oral TabletPSNfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979480losartan potassium 100 MG Oral TabletSCDfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979485losartan potassium 25 MG Oral TabletSCDfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979492losartan potassium 50 MG Oral TabletSCDfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979480Losartan K+ 100 MG Oral TabletSYfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979485Losartan K+ 25 MG Oral TabletSYfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979492Losartan K+ 50 MG Oral TabletSYfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979480Losartan Pot 100 MG Oral TabletSYfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979485Losartan Pot 25 MG Oral TabletSYfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979492Losartan Pot 50 MG Oral TabletSYfa0cf2c2-6238-4edd-94e2-b670b98a0da418
979480losartan potassium 100 MG Oral TabletPSNeea53209-8c3e-430a-8366-e17d5da559e59
979485losartan potassium 25 MG Oral TabletPSNeea53209-8c3e-430a-8366-e17d5da559e59
979492losartan potassium 50 MG Oral TabletPSNeea53209-8c3e-430a-8366-e17d5da559e59
979480losartan potassium 100 MG Oral TabletSCDeea53209-8c3e-430a-8366-e17d5da559e59
979485losartan potassium 25 MG Oral TabletSCDeea53209-8c3e-430a-8366-e17d5da559e59
979492losartan potassium 50 MG Oral TabletSCDeea53209-8c3e-430a-8366-e17d5da559e59
979480Losartan K+ 100 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979485Losartan K+ 25 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979492Losartan K+ 50 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979480Losartan Pot 100 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979485Losartan Pot 25 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979492Losartan Pot 50 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979492losartan potassium 50 MG Oral TabletPSN43fa4762-cc0c-4a3b-a527-6aa7fb7c54647
979492losartan potassium 50 MG Oral TabletSCD43fa4762-cc0c-4a3b-a527-6aa7fb7c54647
979492Losartan K+ 50 MG Oral TabletSY43fa4762-cc0c-4a3b-a527-6aa7fb7c54647
979492Losartan Pot 50 MG Oral TabletSY43fa4762-cc0c-4a3b-a527-6aa7fb7c54647
979492losartan potassium 50 MG Oral TabletPSN54b363c4-00bb-08db-e054-00144ff8d46c4
979492losartan potassium 50 MG Oral TabletPSN68ed9727-987e-4bb6-98b4-b98150bb64044
979492losartan potassium 50 MG Oral TabletSCD54b363c4-00bb-08db-e054-00144ff8d46c4
979492losartan potassium 50 MG Oral TabletSCD68ed9727-987e-4bb6-98b4-b98150bb64044
979492Losartan K+ 50 MG Oral TabletSY68ed9727-987e-4bb6-98b4-b98150bb64044
979492Losartan K+ 50 MG Oral TabletSY54b363c4-00bb-08db-e054-00144ff8d46c4
979492Losartan Pot 50 MG Oral TabletSY68ed9727-987e-4bb6-98b4-b98150bb64044
979492Losartan Pot 50 MG Oral TabletSY54b363c4-00bb-08db-e054-00144ff8d46c4
979492losartan potassium 50 MG Oral TabletPSNc0319153-3e35-4a84-aa63-935b1e0047d83
979492losartan potassium 50 MG Oral TabletSCDc0319153-3e35-4a84-aa63-935b1e0047d83
979492Losartan K+ 50 MG Oral TabletSYc0319153-3e35-4a84-aa63-935b1e0047d83
979492Losartan Pot 50 MG Oral TabletSYc0319153-3e35-4a84-aa63-935b1e0047d83
979492losartan potassium 50 MG Oral TabletPSNde5c0c87-e90b-fc14-e053-2a95a90af0c52
979492losartan potassium 50 MG Oral TabletSCDde5c0c87-e90b-fc14-e053-2a95a90af0c52
979492Losartan K+ 50 MG Oral TabletSYde5c0c87-e90b-fc14-e053-2a95a90af0c52
979492Losartan Pot 50 MG Oral TabletSYde5c0c87-e90b-fc14-e053-2a95a90af0c52
979492losartan potassium 50 MG Oral TabletPSN1f55aaa2-5848-47e0-bba0-6a70b2fa05dd1
979492losartan potassium 50 MG Oral TabletPSN53eebb72-6733-42c3-b015-f5f91b7f4a241
979492losartan potassium 50 MG Oral TabletSCD53eebb72-6733-42c3-b015-f5f91b7f4a241
979492losartan potassium 50 MG Oral TabletSCD1f55aaa2-5848-47e0-bba0-6a70b2fa05dd1
979492Losartan K+ 50 MG Oral TabletSY53eebb72-6733-42c3-b015-f5f91b7f4a241
979492Losartan K+ 50 MG Oral TabletSY1f55aaa2-5848-47e0-bba0-6a70b2fa05dd1
979492Losartan Pot 50 MG Oral TabletSY53eebb72-6733-42c3-b015-f5f91b7f4a241
979492Losartan Pot 50 MG Oral TabletSY1f55aaa2-5848-47e0-bba0-6a70b2fa05dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-361-034354703610330 TABLET, FILM COATED in 1 BOTTLE (43547-361-03) 2022-03-200000-00-00NoNoCurrent
43547-361-094354703610990 TABLET, FILM COATED in 1 BOTTLE (43547-361-09) 2022-03-200000-00-00NoNoCurrent
43547-361-11435470361111000 TABLET, FILM COATED in 1 BOTTLE (43547-361-11) 2022-03-200000-00-00NoNoCurrent
43547-361-5043547036150500 TABLET, FILM COATED in 1 BOTTLE (43547-361-50) 2022-03-200000-00-00NoNoCurrent