Losortan Potassium

Product NDC
63187-071
11-digit product format
631870071
Labeler code
63187
Product ID
63187-071_317c5935-98fa-4bf4-9a07-c19b6daab2ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078243
Marketing category
ANDA
Marketing start
2010-10-04
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
Losortan Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A
Rxcui979480, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-071-30Losortan Potassium30 in 1 BOTTLETABLET, FILM COATED306
63187-071-60Losortan Potassium60 in 1 BOTTLETABLET, FILM COATED606
63187-071-90Losortan Potassium90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
LOSARTANACTIVE MOIETYJMS50MPO89LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-071LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20191121_364fe10e-11ca-4ee6-9f67-c85dec09aca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN364fe10e-11ca-4ee6-9f67-c85dec09aca56
979492losartan potassium 50 MG Oral TabletPSN364fe10e-11ca-4ee6-9f67-c85dec09aca56
979480losartan potassium 100 MG Oral TabletSCD364fe10e-11ca-4ee6-9f67-c85dec09aca56
979492losartan potassium 50 MG Oral TabletSCD364fe10e-11ca-4ee6-9f67-c85dec09aca56
979480Losartan K+ 100 MG Oral TabletSY364fe10e-11ca-4ee6-9f67-c85dec09aca56
979492Losartan K+ 50 MG Oral TabletSY364fe10e-11ca-4ee6-9f67-c85dec09aca56
979480Losartan Pot 100 MG Oral TabletSY364fe10e-11ca-4ee6-9f67-c85dec09aca56
979492Losartan Pot 50 MG Oral TabletSY364fe10e-11ca-4ee6-9f67-c85dec09aca56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-071-306318700713030 TABLET, FILM COATED in 1 BOTTLE (63187-071-30) 2014-04-300000-00-00NoNoCurrent
63187-071-606318700716060 TABLET, FILM COATED in 1 BOTTLE (63187-071-60) 2014-04-300000-00-00NoNoCurrent
63187-071-906318700719090 TABLET, FILM COATED in 1 BOTTLE (63187-071-90) 2014-04-300000-00-00NoNoCurrent