FDA.reportPublic FDA data

Losartan Potassium

Product NDC
43547-362
11-digit product format
435470362
Labeler code
43547
Product ID
43547-362_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
100 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 POTASSIUM100 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
43547-362-032020-04-23C16284748780-19d75b9d0-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
43547-362-092020-04-23C16284748780-19d75b9d0-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
43547-362-112020-04-23C16284748780-19d75b9d0-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
43547-362-502020-04-23C16284748780-19d75b9d0-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
43547-362-032020-01-31C16284748780-19d75b9d0-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
43547-362-092020-01-31C16284748780-19d75b9d0-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
43547-362-112020-01-31C16284748780-19d75b9d0-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
43547-362-502020-01-31C16284748780-19d75b9d0-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
43547-362-03Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED3018
43547-362-09Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED9018
43547-362-11Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED100018
43547-362-50Losartan Potassium500 in 1 BOTTLETABLET, FILM COATED50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-362-03EA - Each43547-36222ae6f71-ff86-444f-bfa6-1ed45a008fa112015-06-09
43547-362-09EA - Each43547-36243623085-ae44-4c79-9270-f59b9407531d12015-06-09
43547-362-11EA - Each43547-362e40fd180-8d3b-46ba-adb2-ebe59743ab9412015-06-09

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
43547-362LOSARTAN 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 TabletPSNde987691-f659-45ab-9c53-402ef7421f4b101
979480losartan potassium 100 MG Oral TabletSCDde987691-f659-45ab-9c53-402ef7421f4b101
979480Losartan K+ 100 MG Oral TabletSYde987691-f659-45ab-9c53-402ef7421f4b101
979480Losartan Pot 100 MG Oral TabletSYde987691-f659-45ab-9c53-402ef7421f4b101
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
979480losartan potassium 100 MG Oral TabletPSN4b298291-4251-4af8-a436-58a3443a79785
979480losartan potassium 100 MG Oral TabletSCD4b298291-4251-4af8-a436-58a3443a79785
979480Losartan K+ 100 MG Oral TabletSY4b298291-4251-4af8-a436-58a3443a79785
979480Losartan Pot 100 MG Oral TabletSY4b298291-4251-4af8-a436-58a3443a79785
979480losartan potassium 100 MG Oral TabletPSNe389a6d7-085c-2499-e053-2995a90aff0e1
979480losartan potassium 100 MG Oral TabletPSN1e18d6b2-b058-4a16-e063-6294a90a78391
979480losartan potassium 100 MG Oral TabletPSN266e3e99-9c35-cb88-e063-6394a90a402d1
979480losartan potassium 100 MG Oral TabletPSN351d3c5c-05c6-921a-e063-6394a90abef91
979480losartan potassium 100 MG Oral TabletSCD1e18d6b2-b058-4a16-e063-6294a90a78391
979480losartan potassium 100 MG Oral TabletSCD351d3c5c-05c6-921a-e063-6394a90abef91
979480losartan potassium 100 MG Oral TabletSCDe389a6d7-085c-2499-e053-2995a90aff0e1
979480losartan potassium 100 MG Oral TabletSCD266e3e99-9c35-cb88-e063-6394a90a402d1
979480Losartan K+ 100 MG Oral TabletSY351d3c5c-05c6-921a-e063-6394a90abef91
979480Losartan K+ 100 MG Oral TabletSY266e3e99-9c35-cb88-e063-6394a90a402d1
979480Losartan K+ 100 MG Oral TabletSY1e18d6b2-b058-4a16-e063-6294a90a78391
979480Losartan K+ 100 MG Oral TabletSYe389a6d7-085c-2499-e053-2995a90aff0e1
979480Losartan Pot 100 MG Oral TabletSY351d3c5c-05c6-921a-e063-6394a90abef91
979480Losartan Pot 100 MG Oral TabletSY266e3e99-9c35-cb88-e063-6394a90a402d1
979480Losartan Pot 100 MG Oral TabletSYe389a6d7-085c-2499-e053-2995a90aff0e1
979480Losartan Pot 100 MG Oral TabletSY1e18d6b2-b058-4a16-e063-6294a90a78391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-362-034354703620330 TABLET, FILM COATED in 1 BOTTLE (43547-362-03) 2022-03-200000-00-00NoNoCurrent
43547-362-094354703620990 TABLET, FILM COATED in 1 BOTTLE (43547-362-09) 2022-03-200000-00-00NoNoCurrent
43547-362-11435470362111000 TABLET, FILM COATED in 1 BOTTLE (43547-362-11) 2022-03-200000-00-00NoNoCurrent
43547-362-5043547036250500 TABLET, FILM COATED in 1 BOTTLE (43547-362-50) 2022-03-200000-00-00NoNoCurrent