Losortan Potassium

Product NDC
45865-684
11-digit product format
458650684
Labeler code
45865
Product ID
45865-684_1f919c57-4ae3-6f17-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078243
Marketing category
ANDA
Marketing start
2010-10-04
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
45865-684-492020-01-31C16284748780-19d75b9d0-fdab-f424-e053-dadaa90a57ceLosartan Potassium Tablets, USP
45865-684-612020-01-31C16284748780-19d75b9d0-fdab-f424-e053-dadaa90a57ceLosartan Potassium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-684-49Losortan Potassium100 in 1 BOTTLETABLET, FILM COATED1001
45865-684-61Losortan Potassium1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-684LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20150914_1f919c57-4ae2-6f17-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSN1f919c57-4ae2-6f17-e054-00144ff88e881
979492losartan potassium 50 MG Oral TabletSCD1f919c57-4ae2-6f17-e054-00144ff88e881
979492Losartan K+ 50 MG Oral TabletSY1f919c57-4ae2-6f17-e054-00144ff88e881
979492Losartan Pot 50 MG Oral TabletSY1f919c57-4ae2-6f17-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-684-4945865068449100 in 1 BOTTLEHistorical
45865-684-61458650684611000 in 1 BOTTLEHistorical