FDA.reportPublic FDA data

Losartan Potassium

Product NDC
71335-1345
11-digit product format
713351345
Labeler code
71335
Product ID
71335-1345_d652e8a8-2038-4bc4-9152-41f71bf92bc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077459
Marketing category
ANDA
Marketing start
2020-07-13
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
2023-12-31
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
71335-1345-12024-01-30C16284748780-11030e365-074b-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
71335-1345-22024-01-30C16284748780-11030e365-074b-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
71335-1345-1Losartan Potassium90 in 1 BOTTLETABLET902
71335-1345-2Losartan Potassium30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1345LOSARTAN POTASSIUM TABLET [BRYANT RANCH PREPACK]2Legacy NDC, 2 package rows20220316_d652e8a8-2038-4bc4-9152-41f71bf92bc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNd652e8a8-2038-4bc4-9152-41f71bf92bc52
979480losartan potassium 100 MG Oral TabletSCDd652e8a8-2038-4bc4-9152-41f71bf92bc52
979480Losartan K+ 100 MG Oral TabletSYd652e8a8-2038-4bc4-9152-41f71bf92bc52
979480Losartan Pot 100 MG Oral TabletSYd652e8a8-2038-4bc4-9152-41f71bf92bc52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1345-17133513450190 TABLET in 1 BOTTLE (71335-1345-1) 90 tablet2019-09-180000-00-00NoNoCurrent
71335-1345-27133513450230 TABLET in 1 BOTTLE (71335-1345-2) 30 tablet2019-09-180000-00-00NoNoCurrent