FDA.reportPublic FDA data

Losartan Potassium

Product NDC
65862-203
11-digit product format
658620203
Labeler code
65862
Product ID
65862-203_1942e030-0f36-4f65-9f60-4898439afc61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090083
Marketing category
ANDA
Marketing start
2010-10-06
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-203-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED3025
65862-203-90Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED9025
65862-203-99Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED100025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-203-30EA - Each65862-20399ffac92-d2fb-43af-afd5-7f7b9fbb622b12012-07-24
65862-203-90EA - Each65862-2033ab26609-c02c-4433-a357-20c3fe4980ef12012-07-24
65862-203-99EA - Each65862-20373cc2b7b-bca8-437c-bc1e-27c1c4f819a912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
WATERINACTIVE INGREDIENT059QF0KO0RLOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-203LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]23Current NDC, Legacy NDC, 3 package rows20240529_31366b4b-dfd6-4fda-babe-2cb3d2c14a2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN4d7a0e82-4791-4e3f-932a-2f1a2993ba36104
979480losartan potassium 100 MG Oral TabletSCD4d7a0e82-4791-4e3f-932a-2f1a2993ba36104
979480Losartan K+ 100 MG Oral TabletSY4d7a0e82-4791-4e3f-932a-2f1a2993ba36104
979480Losartan Pot 100 MG Oral TabletSY4d7a0e82-4791-4e3f-932a-2f1a2993ba36104
979480losartan potassium 100 MG Oral TabletPSN73bb1210-fa46-4c88-b07c-14ff5580ef1836
979485losartan potassium 25 MG Oral TabletPSN73bb1210-fa46-4c88-b07c-14ff5580ef1836
979492losartan potassium 50 MG Oral TabletPSN73bb1210-fa46-4c88-b07c-14ff5580ef1836
979480losartan potassium 100 MG Oral TabletSCD73bb1210-fa46-4c88-b07c-14ff5580ef1836
979485losartan potassium 25 MG Oral TabletSCD73bb1210-fa46-4c88-b07c-14ff5580ef1836
979492losartan potassium 50 MG Oral TabletSCD73bb1210-fa46-4c88-b07c-14ff5580ef1836
979480Losartan K+ 100 MG Oral TabletSY73bb1210-fa46-4c88-b07c-14ff5580ef1836
979485Losartan K+ 25 MG Oral TabletSY73bb1210-fa46-4c88-b07c-14ff5580ef1836
979492Losartan K+ 50 MG Oral TabletSY73bb1210-fa46-4c88-b07c-14ff5580ef1836
979480Losartan Pot 100 MG Oral TabletSY73bb1210-fa46-4c88-b07c-14ff5580ef1836
979485Losartan Pot 25 MG Oral TabletSY73bb1210-fa46-4c88-b07c-14ff5580ef1836
979492Losartan Pot 50 MG Oral TabletSY73bb1210-fa46-4c88-b07c-14ff5580ef1836
979480losartan potassium 100 MG Oral TabletPSNf9a92771-5c73-4f17-ac38-29fabfd4a91928
979480losartan potassium 100 MG Oral TabletSCDf9a92771-5c73-4f17-ac38-29fabfd4a91928
979480Losartan K+ 100 MG Oral TabletSYf9a92771-5c73-4f17-ac38-29fabfd4a91928
979480Losartan Pot 100 MG Oral TabletSYf9a92771-5c73-4f17-ac38-29fabfd4a91928
979480losartan potassium 100 MG Oral TabletPSN31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979485losartan potassium 25 MG Oral TabletPSN31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979492losartan potassium 50 MG Oral TabletPSN31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979480losartan potassium 100 MG Oral TabletSCD31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979485losartan potassium 25 MG Oral TabletSCD31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979492losartan potassium 50 MG Oral TabletSCD31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979480Losartan K+ 100 MG Oral TabletSY31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979485Losartan K+ 25 MG Oral TabletSY31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979492Losartan K+ 50 MG Oral TabletSY31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979480Losartan Pot 100 MG Oral TabletSY31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979485Losartan Pot 25 MG Oral TabletSY31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979492Losartan Pot 50 MG Oral TabletSY31366b4b-dfd6-4fda-babe-2cb3d2c14a2b25
979480losartan potassium 100 MG Oral TabletPSN25c93638-7016-47d2-a57c-e4a5245ca41b19
979480losartan potassium 100 MG Oral TabletSCD25c93638-7016-47d2-a57c-e4a5245ca41b19
979480Losartan K+ 100 MG Oral TabletSY25c93638-7016-47d2-a57c-e4a5245ca41b19
979480Losartan Pot 100 MG Oral TabletSY25c93638-7016-47d2-a57c-e4a5245ca41b19
979480losartan potassium 100 MG Oral TabletPSNd9ced981-d791-6600-e053-2995a90ace3b6
979480losartan potassium 100 MG Oral TabletSCDd9ced981-d791-6600-e053-2995a90ace3b6
979480Losartan K+ 100 MG Oral TabletSYd9ced981-d791-6600-e053-2995a90ace3b6
979480Losartan Pot 100 MG Oral TabletSYd9ced981-d791-6600-e053-2995a90ace3b6
979480losartan potassium 100 MG Oral TabletPSNf6bd21bc-127f-4c11-ad5e-b176a6abd0645
979480losartan potassium 100 MG Oral TabletSCDf6bd21bc-127f-4c11-ad5e-b176a6abd0645
979480Losartan K+ 100 MG Oral TabletSYf6bd21bc-127f-4c11-ad5e-b176a6abd0645
979480Losartan Pot 100 MG Oral TabletSYf6bd21bc-127f-4c11-ad5e-b176a6abd0645
979480losartan potassium 100 MG Oral TabletPSN597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979480losartan potassium 100 MG Oral TabletPSN8a70d474-ee10-67b1-e053-2a95a90ac9462
979492losartan potassium 50 MG Oral TabletPSN597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979480losartan potassium 100 MG Oral TabletSCD597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979480losartan potassium 100 MG Oral TabletSCD8a70d474-ee10-67b1-e053-2a95a90ac9462
979492losartan potassium 50 MG Oral TabletSCD597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979480Losartan K+ 100 MG Oral TabletSY8a70d474-ee10-67b1-e053-2a95a90ac9462
979480Losartan K+ 100 MG Oral TabletSY597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979492Losartan K+ 50 MG Oral TabletSY597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979480Losartan Pot 100 MG Oral TabletSY8a70d474-ee10-67b1-e053-2a95a90ac9462
979480Losartan Pot 100 MG Oral TabletSY597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979492Losartan Pot 50 MG Oral TabletSY597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979480losartan potassium 100 MG Oral TabletPSN8081b9f8-0b52-46dd-93f2-6bc608b753391
979480losartan potassium 100 MG Oral TabletSCD8081b9f8-0b52-46dd-93f2-6bc608b753391
979480Losartan K+ 100 MG Oral TabletSY8081b9f8-0b52-46dd-93f2-6bc608b753391
979480Losartan Pot 100 MG Oral TabletSY8081b9f8-0b52-46dd-93f2-6bc608b753391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-203-22658620203222000 TABLET, FILM COATED in 1 BAG (65862-203-22)06-OCT-10Current
65862-203-306586202033030 TABLET, FILM COATED in 1 BOTTLE (65862-203-30) 2010-10-060000-00-00NoNoCurrent
65862-203-906586202039090 TABLET, FILM COATED in 1 BOTTLE (65862-203-90) 2010-10-060000-00-00NoNoCurrent
65862-203-99658620203991000 TABLET, FILM COATED in 1 BOTTLE (65862-203-99) 2010-10-060000-00-00NoNoCurrent