FDA.reportPublic FDA data

Losartan Potassium

Product NDC
45865-687
11-digit product format
458650687
Labeler code
45865
Product ID
45865-687_7d789f3b-68f1-33c7-e053-2991aa0a0330
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA090467
Marketing category
ANDA
Marketing start
2010-10-06
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
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
45865-687-302025-01-30C16284748780-12cef2736-a3f3-d83d-e063-dadaa90ab31fThese 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 Rx Only Initial U.S. Approval: 1995
45865-687-492025-01-30C16284748780-12cef2736-a3f3-d83d-e063-dadaa90ab31fThese 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 Rx Only Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-687-30Losartan Potassium30 in 1 BOTTLETABLET302
45865-687-49Losartan Potassium100 in 1 CARTONTABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-687LOSARTAN POTASSIUM TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20181221_7d789f2c-8d42-9ec5-e053-2a91aa0a3355.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN7d789f2c-8d42-9ec5-e053-2a91aa0a33552
979485losartan potassium 25 MG Oral TabletSCD7d789f2c-8d42-9ec5-e053-2a91aa0a33552
979485Losartan K+ 25 MG Oral TabletSY7d789f2c-8d42-9ec5-e053-2a91aa0a33552
979485Losartan Pot 25 MG Oral TabletSY7d789f2c-8d42-9ec5-e053-2a91aa0a33552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-687-304586506873030 TABLET in 1 BOTTLE (45865-687-30) 30 tablet2018-06-010000-00-00NoNoCurrent
45865-687-4945865068749100 TABLET in 1 CARTON (45865-687-49) 100 tablet2018-06-010000-00-00NoNoCurrent