FDA.reportPublic FDA data

LOSARTAN POTASSIUM

Product NDC
13107-197
11-digit product format
131070197
Labeler code
13107
Product ID
13107-197_d5571a70-fe83-4277-ac42-ffaff2e051b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOSARTAN POTASSIUM
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA090083
Marketing category
ANDA
Marketing start
2010-10-06
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13107-197-302024-01-30C16284748780-11030e364-f988-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
13107-197-902024-01-30C16284748780-11030e364-f988-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
13107-197-992024-01-30C16284748780-11030e364-f988-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-197-30LOSARTAN POTASSIUM30 in 1 BOTTLETABLET301
13107-197-90LOSARTAN POTASSIUM90 in 1 BOTTLETABLET901
13107-197-99LOSARTAN POTASSIUM1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-197-30EA - Each13107-19765d5d675-2dde-4c8a-bb79-4b901813fb7812019-04-11
13107-197-90EA - Each13107-19705663053-f396-48bb-b5fb-44dd594fb70312019-04-11
13107-197-99EA - Each13107-197ed73322f-e717-43f3-9658-72f12b33d07412019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-197LOSARTAN POTASSIUM TABLET [AUROLIFE PHARMA, LLC]1Legacy NDC, 3 package rows20190321_d5571a70-fe83-4277-ac42-ffaff2e051b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNd5571a70-fe83-4277-ac42-ffaff2e051b21
979485losartan potassium 25 MG Oral TabletPSNd5571a70-fe83-4277-ac42-ffaff2e051b21
979492losartan potassium 50 MG Oral TabletPSNd5571a70-fe83-4277-ac42-ffaff2e051b21
979480losartan potassium 100 MG Oral TabletSCDd5571a70-fe83-4277-ac42-ffaff2e051b21
979485losartan potassium 25 MG Oral TabletSCDd5571a70-fe83-4277-ac42-ffaff2e051b21
979492losartan potassium 50 MG Oral TabletSCDd5571a70-fe83-4277-ac42-ffaff2e051b21
979480Losartan K+ 100 MG Oral TabletSYd5571a70-fe83-4277-ac42-ffaff2e051b21
979485Losartan K+ 25 MG Oral TabletSYd5571a70-fe83-4277-ac42-ffaff2e051b21
979492Losartan K+ 50 MG Oral TabletSYd5571a70-fe83-4277-ac42-ffaff2e051b21
979480Losartan Pot 100 MG Oral TabletSYd5571a70-fe83-4277-ac42-ffaff2e051b21
979485Losartan Pot 25 MG Oral TabletSYd5571a70-fe83-4277-ac42-ffaff2e051b21
979492Losartan Pot 50 MG Oral TabletSYd5571a70-fe83-4277-ac42-ffaff2e051b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-197-301310701973030 TABLET in 1 BOTTLE (13107-197-30) 30 tablet2010-10-060000-00-00NoNoCurrent
13107-197-901310701979090 TABLET in 1 BOTTLE (13107-197-90) 90 tablet2010-10-060000-00-00NoNoCurrent
13107-197-99131070197991000 TABLET in 1 BOTTLE (13107-197-99) 1000 tablet2010-10-060000-00-00NoNoCurrent