FDA.reportPublic FDA data

Losartan Potassium

Product NDC
65862-201
11-digit product format
658620201
Labeler code
65862
Product ID
65862-201_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
25 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 POTASSIUM25 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
65862-201-05Losartan Potassium500 in 1 BOTTLETABLET, FILM COATED50025
65862-201-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED3025
65862-201-90Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED9025
65862-201-99Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED100025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-201-90EA - Each65862-20129c03b91-70b4-413e-b514-6334cf38362912012-07-24
65862-201-99EA - Each65862-201efa5aa2d-d37e-4e73-ae5e-1d374cb9db2a12012-07-24

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
65862-201LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]23Current NDC, Legacy NDC, 4 package rows20240529_31366b4b-dfd6-4fda-babe-2cb3d2c14a2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 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
979485losartan potassium 25 MG Oral TabletPSNf7cf8a7d-90f1-46a3-abff-1eb316aa7d7220
979485losartan potassium 25 MG Oral TabletSCDf7cf8a7d-90f1-46a3-abff-1eb316aa7d7220
979485Losartan K+ 25 MG Oral TabletSYf7cf8a7d-90f1-46a3-abff-1eb316aa7d7220
979485Losartan Pot 25 MG Oral TabletSYf7cf8a7d-90f1-46a3-abff-1eb316aa7d7220
979485losartan potassium 25 MG Oral TabletPSN45d0b1cc-d88d-4044-9692-c143cdf7a1b88
979485losartan potassium 25 MG Oral TabletPSN8dfe73ee-7815-404b-801a-57482688271c8
979485losartan potassium 25 MG Oral TabletSCD8dfe73ee-7815-404b-801a-57482688271c8
979485losartan potassium 25 MG Oral TabletSCD45d0b1cc-d88d-4044-9692-c143cdf7a1b88
979485Losartan K+ 25 MG Oral TabletSY45d0b1cc-d88d-4044-9692-c143cdf7a1b88
979485Losartan K+ 25 MG Oral TabletSY8dfe73ee-7815-404b-801a-57482688271c8
979485Losartan Pot 25 MG Oral TabletSY45d0b1cc-d88d-4044-9692-c143cdf7a1b88
979485Losartan Pot 25 MG Oral TabletSY8dfe73ee-7815-404b-801a-57482688271c8
979485losartan potassium 25 MG Oral TabletPSN16a6a582-eb4d-41bc-9d49-fc1d4117b29a7
979485losartan potassium 25 MG Oral TabletSCD16a6a582-eb4d-41bc-9d49-fc1d4117b29a7
979485Losartan K+ 25 MG Oral TabletSY16a6a582-eb4d-41bc-9d49-fc1d4117b29a7
979485Losartan Pot 25 MG Oral TabletSY16a6a582-eb4d-41bc-9d49-fc1d4117b29a7
979485losartan potassium 25 MG Oral TabletPSNd9dfae69-9ce7-0c6b-e053-2a95a90aace84
979485losartan potassium 25 MG Oral TabletSCDd9dfae69-9ce7-0c6b-e053-2a95a90aace84
979485Losartan K+ 25 MG Oral TabletSYd9dfae69-9ce7-0c6b-e053-2a95a90aace84
979485Losartan Pot 25 MG Oral TabletSYd9dfae69-9ce7-0c6b-e053-2a95a90aace84
979485losartan potassium 25 MG Oral TabletPSNcff0c9eb-fafd-48e7-a053-036b676bf57d3
979485losartan potassium 25 MG Oral TabletPSN9130921b-02f0-82d6-e053-2995a90a9c0a3
979485losartan potassium 25 MG Oral TabletSCD9130921b-02f0-82d6-e053-2995a90a9c0a3
979485losartan potassium 25 MG Oral TabletSCDcff0c9eb-fafd-48e7-a053-036b676bf57d3
979485Losartan K+ 25 MG Oral TabletSYcff0c9eb-fafd-48e7-a053-036b676bf57d3
979485Losartan K+ 25 MG Oral TabletSY9130921b-02f0-82d6-e053-2995a90a9c0a3
979485Losartan Pot 25 MG Oral TabletSYcff0c9eb-fafd-48e7-a053-036b676bf57d3
979485Losartan Pot 25 MG Oral TabletSY9130921b-02f0-82d6-e053-2995a90a9c0a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-201-0565862020105500 TABLET, FILM COATED in 1 BOTTLE (65862-201-05) 2010-10-060000-00-00NoNoCurrent
65862-201-196586202011910000 TABLET, FILM COATED in 1 BAG (65862-201-19)06-OCT-10Current
65862-201-306586202013030 TABLET, FILM COATED in 1 BOTTLE (65862-201-30) 2019-03-060000-00-00NoNoCurrent
65862-201-906586202019090 TABLET, FILM COATED in 1 BOTTLE (65862-201-90) 2010-10-060000-00-00NoNoCurrent
65862-201-99658620201991000 TABLET, FILM COATED in 1 BOTTLE (65862-201-99) 2010-10-060000-00-00NoNoCurrent