Losortan Potassium

Product NDC
53808-1072
11-digit product format
538081072
Labeler code
53808
Product ID
53808-1072_f59e6769-f44a-4190-a286-159a2e66c193
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA078243
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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
53808-1072-22020-01-31C16284748780-19d75b9d0-5929-f424-e053-dadaa90a57ceLosartan Potassium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1072-2Losortan Potassium60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LOSARTANACTIVE MOIETYJMS50MPO89LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1072LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20150113_1fb4fabd-17f0-4aa5-83fa-b54bdeef0c68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSN1fb4fabd-17f0-4aa5-83fa-b54bdeef0c681
979492losartan potassium 50 MG Oral TabletSCD1fb4fabd-17f0-4aa5-83fa-b54bdeef0c681
979492Losartan K+ 50 MG Oral TabletSY1fb4fabd-17f0-4aa5-83fa-b54bdeef0c681
979492Losartan Pot 50 MG Oral TabletSY1fb4fabd-17f0-4aa5-83fa-b54bdeef0c681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1072-25380810720260 in 1 BLISTER PACKHistorical