FDA.reportPublic FDA data

LOSARTAN POTASSIUM

Product NDC
50090-5338
11-digit product format
500905338
Labeler code
50090
Product ID
50090-5338_ac26750a-68cd-4640-9b7f-2b6d498ea898
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOSARTAN POTASSIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090382
Marketing category
ANDA
Marketing start
2019-10-09
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
2022-12-31
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
50090-5338-02023-01-30C16284748780-1f386c64a-3f41-0266-e053-dadaa90a7c1aThese 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
50090-5338-0LOSARTAN POTASSIUM100 mg90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5338LOSARTAN POTASSIUM 100 MG (LOSARTAN POTASSIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210303_cda520b7-ae84-4bd7-b298-11934f4fcc57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNcda520b7-ae84-4bd7-b298-11934f4fcc571
979480losartan potassium 100 MG Oral TabletSCDcda520b7-ae84-4bd7-b298-11934f4fcc571
979480Losartan K+ 100 MG Oral TabletSYcda520b7-ae84-4bd7-b298-11934f4fcc571
979480Losartan Pot 100 MG Oral TabletSYcda520b7-ae84-4bd7-b298-11934f4fcc571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5338-05009053380090 TABLET, FILM COATED in 1 BOTTLE (50090-5338-0) 2020-11-040000-00-00NoNoCurrent