Losartan Potassium

Product NDC
65841-731
11-digit product format
658410731
Labeler code
65841
Product ID
65841-731_36fa833c-716f-4b69-9326-3c54753240dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078243
Marketing category
ANDA
Marketing start
2010-10-04
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan Potassium
Listing expiration
2027-12-31

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
65841-731-01Losartan Potassium100 in 1 BOTTLETABLET, FILM COATED10012
65841-731-06Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED3012
65841-731-10Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED100012
65841-731-16Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED9012
65841-731-30Losartan Potassium10 in 1 BLISTER PACKTABLET, FILM COATED1012
65841-731-77Losartan Potassium10 in 1 CARTONTABLET, FILM COATED1012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-731LOSARTAN POTASSIUM TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 6 package rows20241204_9ccd6823-e813-472c-99cd-c6ef25e74bed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN9ccd6823-e813-472c-99cd-c6ef25e74bed12
979485losartan potassium 25 MG Oral TabletPSN9ccd6823-e813-472c-99cd-c6ef25e74bed12
979492losartan potassium 50 MG Oral TabletPSN9ccd6823-e813-472c-99cd-c6ef25e74bed12
979480losartan potassium 100 MG Oral TabletSCD9ccd6823-e813-472c-99cd-c6ef25e74bed12
979485losartan potassium 25 MG Oral TabletSCD9ccd6823-e813-472c-99cd-c6ef25e74bed12
979492losartan potassium 50 MG Oral TabletSCD9ccd6823-e813-472c-99cd-c6ef25e74bed12
979480Losartan K+ 100 MG Oral TabletSY9ccd6823-e813-472c-99cd-c6ef25e74bed12
979485Losartan K+ 25 MG Oral TabletSY9ccd6823-e813-472c-99cd-c6ef25e74bed12
979492Losartan K+ 50 MG Oral TabletSY9ccd6823-e813-472c-99cd-c6ef25e74bed12
979480Losartan Pot 100 MG Oral TabletSY9ccd6823-e813-472c-99cd-c6ef25e74bed12
979485Losartan Pot 25 MG Oral TabletSY9ccd6823-e813-472c-99cd-c6ef25e74bed12
979492Losartan Pot 50 MG Oral TabletSY9ccd6823-e813-472c-99cd-c6ef25e74bed12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-731-0165841073101100 TABLET, FILM COATED in 1 BOTTLE (65841-731-01) 2010-10-040000-00-00NoNoCurrent
65841-731-066584107310630 TABLET, FILM COATED in 1 BOTTLE (65841-731-06) 2010-10-040000-00-00NoNoCurrent
65841-731-10658410731101000 TABLET, FILM COATED in 1 BOTTLE (65841-731-10) 2010-10-040000-00-00NoNoCurrent
65841-731-166584107311690 TABLET, FILM COATED in 1 BOTTLE (65841-731-16) 2010-10-040000-00-00NoNoCurrent
65841-731-306584107313010 in 1 BLISTER PACKHistorical
65841-731-776584107317710 BLISTER PACK in 1 CARTON (65841-731-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-731-30) 10 blister pack2010-10-040000-00-00NoNoCurrent