Losartan Potassium

Product NDC
55154-4783
11-digit product format
551544783
Labeler code
55154
Product ID
55154-4783_016461a7-40a7-4ebc-9342-66ea16cdb6fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078243
Marketing category
ANDA
Marketing start
2010-10-12
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

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 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4783-0Losartan Potassium1 in 1 BLISTER PACKTABLET, FILM COATED120
55154-4783-0Losartan Potassium10 in 1 BAGTABLET, FILM COATED1020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
LOSARTANACTIVE MOIETYJMS50MPO89LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CARDINAL HEALTH]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4783LOSARTAN POTASSIUM TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]19Current NDC, Legacy NDC, 2 package rows20241018_021cd76a-b093-4704-8410-5e7d01e20a54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN021cd76a-b093-4704-8410-5e7d01e20a5420
979485losartan potassium 25 MG Oral TabletPSN021cd76a-b093-4704-8410-5e7d01e20a5420
979492losartan potassium 50 MG Oral TabletPSN021cd76a-b093-4704-8410-5e7d01e20a5420
979480losartan potassium 100 MG Oral TabletSCD021cd76a-b093-4704-8410-5e7d01e20a5420
979485losartan potassium 25 MG Oral TabletSCD021cd76a-b093-4704-8410-5e7d01e20a5420
979492losartan potassium 50 MG Oral TabletSCD021cd76a-b093-4704-8410-5e7d01e20a5420
979480Losartan K+ 100 MG Oral TabletSY021cd76a-b093-4704-8410-5e7d01e20a5420
979485Losartan K+ 25 MG Oral TabletSY021cd76a-b093-4704-8410-5e7d01e20a5420
979492Losartan K+ 50 MG Oral TabletSY021cd76a-b093-4704-8410-5e7d01e20a5420
979480Losartan Pot 100 MG Oral TabletSY021cd76a-b093-4704-8410-5e7d01e20a5420
979485Losartan Pot 25 MG Oral TabletSY021cd76a-b093-4704-8410-5e7d01e20a5420
979492Losartan Pot 50 MG Oral TabletSY021cd76a-b093-4704-8410-5e7d01e20a5420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4783-05515447830010 BLISTER PACK in 1 BAG (55154-4783-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2010-10-120000-00-00NoNoCurrent