FDA.reportPublic FDA data

Losartan Potassium

Product NDC
71335-1439
11-digit product format
713351439
Labeler code
71335
Product ID
71335-1439_325b72c4-d00f-47a8-a12b-9e0fa5c82d4e
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
25 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
71335-1439-12024-01-30C16284748780-11030e365-1190-111a-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
71335-1439-22024-01-30C16284748780-11030e365-1190-111a-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
71335-1439-32024-01-30C16284748780-11030e365-1190-111a-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
71335-1439-42024-01-30C16284748780-11030e365-1190-111a-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
71335-1439-52024-01-30C16284748780-11030e365-1190-111a-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
71335-1439-1Losartan Potassium90 in 1 BOTTLETABLET90100
71335-1439-2Losartan Potassium30 in 1 BOTTLETABLET30100
71335-1439-3Losartan Potassium60 in 1 BOTTLETABLET60100
71335-1439-4Losartan Potassium100 in 1 BOTTLETABLET100100
71335-1439-5Losartan Potassium10 in 1 BOTTLETABLET10100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1439LOSARTAN POTASSIUM TABLET [BRYANT RANCH PREPACK]100Legacy NDC, 5 package rows20220507_a5179fa4-0b29-4bf0-af0b-660c2ca52199.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSNa5179fa4-0b29-4bf0-af0b-660c2ca52199100
979485losartan potassium 25 MG Oral TabletSCDa5179fa4-0b29-4bf0-af0b-660c2ca52199100
979485Losartan K+ 25 MG Oral TabletSYa5179fa4-0b29-4bf0-af0b-660c2ca52199100
979485Losartan Pot 25 MG Oral TabletSYa5179fa4-0b29-4bf0-af0b-660c2ca52199100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1439-17133514390190 TABLET in 1 BOTTLE (71335-1439-1) 90 tablet2022-05-040000-00-00NoNoCurrent
71335-1439-27133514390230 TABLET in 1 BOTTLE (71335-1439-2) 30 tablet2022-05-040000-00-00NoNoCurrent
71335-1439-37133514390360 TABLET in 1 BOTTLE (71335-1439-3) 60 tablet2022-05-040000-00-00NoNoCurrent
71335-1439-471335143904100 TABLET in 1 BOTTLE (71335-1439-4) 100 tablet2022-05-040000-00-00NoNoCurrent
71335-1439-57133514390510 TABLET in 1 BOTTLE (71335-1439-5) 10 tablet2022-05-040000-00-00NoNoCurrent