FDA.reportPublic FDA data

Losartan Potassium

Product NDC
65862-202
11-digit product format
658620202
Labeler code
65862
Product ID
65862-202_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
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
Losartan Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM50 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
65862-202-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED3025
65862-202-90Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED9025
65862-202-99Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED100025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-202-30EA - Each65862-202f19984a5-bd94-4a5d-9bb1-f026e8fe144c12012-07-24
65862-202-90EA - Each65862-2029684db77-55c7-456b-b27f-65a095f1de4012012-07-24
65862-202-99EA - Each65862-202987f1cbf-73e5-45a7-b995-174a60fcad2812012-07-24

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
65862-202LOSARTAN 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
979492losartan potassium 50 MG Oral TabletPSN0c728db3-86ae-4ed9-b86a-78ff8d18876a104
979492losartan potassium 50 MG Oral TabletSCD0c728db3-86ae-4ed9-b86a-78ff8d18876a104
979492Losartan K+ 50 MG Oral TabletSY0c728db3-86ae-4ed9-b86a-78ff8d18876a104
979492Losartan Pot 50 MG Oral TabletSY0c728db3-86ae-4ed9-b86a-78ff8d18876a104
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
979492losartan potassium 50 MG Oral TabletPSN5f7612dc-dccf-49e2-b541-3dab9dc1f97a30
979492losartan potassium 50 MG Oral TabletSCD5f7612dc-dccf-49e2-b541-3dab9dc1f97a30
979492Losartan K+ 50 MG Oral TabletSY5f7612dc-dccf-49e2-b541-3dab9dc1f97a30
979492Losartan Pot 50 MG Oral TabletSY5f7612dc-dccf-49e2-b541-3dab9dc1f97a30
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
979492losartan potassium 50 MG Oral TabletPSN41069514-0491-41fe-b7fe-a52d42d3384821
979492losartan potassium 50 MG Oral TabletSCD41069514-0491-41fe-b7fe-a52d42d3384821
979492Losartan K+ 50 MG Oral TabletSY41069514-0491-41fe-b7fe-a52d42d3384821
979492Losartan Pot 50 MG Oral TabletSY41069514-0491-41fe-b7fe-a52d42d3384821
979492losartan potassium 50 MG Oral TabletPSNdf4f55f0-fb11-4f6f-a7ed-127b50f955fc10
979492losartan potassium 50 MG Oral TabletSCDdf4f55f0-fb11-4f6f-a7ed-127b50f955fc10
979492Losartan K+ 50 MG Oral TabletSYdf4f55f0-fb11-4f6f-a7ed-127b50f955fc10
979492Losartan Pot 50 MG Oral TabletSYdf4f55f0-fb11-4f6f-a7ed-127b50f955fc10
979492losartan potassium 50 MG Oral TabletPSN2a7513c4-b73b-46fe-ba86-6e58658cdbc77
979492losartan potassium 50 MG Oral TabletSCD2a7513c4-b73b-46fe-ba86-6e58658cdbc77
979492Losartan K+ 50 MG Oral TabletSY2a7513c4-b73b-46fe-ba86-6e58658cdbc77
979492Losartan Pot 50 MG Oral TabletSY2a7513c4-b73b-46fe-ba86-6e58658cdbc77
979492losartan potassium 50 MG Oral TabletPSN2752aee1-97b6-4f72-a04f-8f175e3d90456
979492losartan potassium 50 MG Oral TabletSCD2752aee1-97b6-4f72-a04f-8f175e3d90456
979492Losartan K+ 50 MG Oral TabletSY2752aee1-97b6-4f72-a04f-8f175e3d90456
979492Losartan Pot 50 MG Oral TabletSY2752aee1-97b6-4f72-a04f-8f175e3d90456
979492losartan potassium 50 MG Oral TabletPSNd9de3627-9aa2-65c8-e053-2995a90ab5ec4
979492losartan potassium 50 MG Oral TabletSCDd9de3627-9aa2-65c8-e053-2995a90ab5ec4
979492Losartan K+ 50 MG Oral TabletSYd9de3627-9aa2-65c8-e053-2995a90ab5ec4
979492Losartan Pot 50 MG Oral TabletSYd9de3627-9aa2-65c8-e053-2995a90ab5ec4
979492losartan potassium 50 MG Oral TabletPSN8c2b3412-254b-8fa9-e053-2a95a90a7dc63
979492losartan potassium 50 MG Oral TabletPSN44050993-c20e-45d4-baeb-f77d912961683
979492losartan potassium 50 MG Oral TabletPSN91305ca4-7d56-2052-e053-2995a90a5d613
979492losartan potassium 50 MG Oral TabletSCD44050993-c20e-45d4-baeb-f77d912961683
979492losartan potassium 50 MG Oral TabletSCD8c2b3412-254b-8fa9-e053-2a95a90a7dc63
979492losartan potassium 50 MG Oral TabletSCD91305ca4-7d56-2052-e053-2995a90a5d613
979492Losartan K+ 50 MG Oral TabletSY91305ca4-7d56-2052-e053-2995a90a5d613
979492Losartan K+ 50 MG Oral TabletSY8c2b3412-254b-8fa9-e053-2a95a90a7dc63
979492Losartan K+ 50 MG Oral TabletSY44050993-c20e-45d4-baeb-f77d912961683
979492Losartan Pot 50 MG Oral TabletSY8c2b3412-254b-8fa9-e053-2a95a90a7dc63
979492Losartan Pot 50 MG Oral TabletSY44050993-c20e-45d4-baeb-f77d912961683
979492Losartan Pot 50 MG Oral TabletSY91305ca4-7d56-2052-e053-2995a90a5d613
979480losartan potassium 100 MG Oral TabletPSN597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979492losartan potassium 50 MG Oral TabletPSN597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979480losartan potassium 100 MG Oral TabletSCD597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979492losartan potassium 50 MG Oral TabletSCD597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
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 TabletSY597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979492Losartan Pot 50 MG Oral TabletSY597cddb1-f7e0-fe1c-e053-2a91aa0aa8b42
979492losartan potassium 50 MG Oral TabletPSN17aca8b5-3d84-48f2-adf9-72a9c194303d1
979492losartan potassium 50 MG Oral TabletSCD17aca8b5-3d84-48f2-adf9-72a9c194303d1
979492Losartan K+ 50 MG Oral TabletSY17aca8b5-3d84-48f2-adf9-72a9c194303d1
979492Losartan Pot 50 MG Oral TabletSY17aca8b5-3d84-48f2-adf9-72a9c194303d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-202-306586202023030 TABLET, FILM COATED in 1 BOTTLE (65862-202-30) 2010-10-060000-00-00NoNoCurrent
65862-202-81658620202818000 TABLET, FILM COATED in 1 BAG (65862-202-81)06-OCT-10Current
65862-202-906586202029090 TABLET, FILM COATED in 1 BOTTLE (65862-202-90) 2010-10-060000-00-00NoNoCurrent
65862-202-99658620202991000 TABLET, FILM COATED in 1 BOTTLE (65862-202-99) 2010-10-060000-00-00NoNoCurrent