LOSARTAN POTASSIUM

Product NDC
42571-112
11-digit product format
425710112
Labeler code
42571
Product ID
42571-112_38dcaa90-daef-cef7-e063-6294a90ab743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA091541
Marketing category
ANDA
Marketing start
2012-12-06
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
42571-112-10LOSARTAN POTASSIUM1000 in 1 BOTTLETABLET, FILM COATED100016
42571-112-30LOSARTAN POTASSIUM30 in 1 BOTTLETABLET, FILM COATED3016
42571-112-90LOSARTAN POTASSIUM90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-112-10EA - Each42571-112efa624af-1009-4119-8ce9-4b78b167ee8012013-12-02
42571-112-90EA - Each42571-112e39272b6-bf6f-4cdd-9e1e-b22afa6cf15c12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ) TABLET, FILM COATED [MICRO LABS LIMITED]9
losartanACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ) TABLET, FILM COATED [MICRO LABS LIMITED]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ) TABLET, FILM COATED [MICRO LABS LIMITED]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ) TABLET, FILM COATED [MICRO LABS LIMITED]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ) TABLET, FILM COATED [MICRO LABS LIMITED]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ) TABLET, FILM COATED [MICRO LABS LIMITED]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ) TABLET, FILM COATED [MICRO LABS LIMITED]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ) TABLET, FILM COATED [MICRO LABS LIMITED]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ) TABLET, FILM COATED [MICRO LABS LIMITED]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-112LOSARTAN POTASSIUM TABLET, FILM COATED [MICRO LABS LIMITED]15Current NDC, Legacy NDC, 3 package rows20211207_f2f2b6c6-0ab1-483f-b4a2-78dfe3200153.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979485losartan potassium 25 MG Oral TabletPSNf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979492losartan potassium 50 MG Oral TabletPSNf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979480losartan potassium 100 MG Oral TabletSCDf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979485losartan potassium 25 MG Oral TabletSCDf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979492losartan potassium 50 MG Oral TabletSCDf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979480Losartan K+ 100 MG Oral TabletSYf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979485Losartan K+ 25 MG Oral TabletSYf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979492Losartan K+ 50 MG Oral TabletSYf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979480Losartan Pot 100 MG Oral TabletSYf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979485Losartan Pot 25 MG Oral TabletSYf2f2b6c6-0ab1-483f-b4a2-78dfe320015316
979492Losartan Pot 50 MG Oral TabletSYf2f2b6c6-0ab1-483f-b4a2-78dfe320015316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42571-112-10425710112101000 TABLET, FILM COATED in 1 BOTTLE (42571-112-10) 2012-12-060000-00-00NoNoCurrent
42571-112-304257101123030 TABLET, FILM COATED in 1 BOTTLE (42571-112-30) 2012-12-060000-00-00NoNoCurrent
42571-112-904257101129090 TABLET, FILM COATED in 1 BOTTLE (42571-112-90) 2012-12-060000-00-00NoNoCurrent