FDA.reportPublic FDA data

Losartan Potassium

Product NDC
68071-2786
11-digit product format
680712786
Labeler code
68071
Product ID
68071-2786_e389a6d7-085d-2499-e053-2995a90aff0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091497
Marketing category
ANDA
Marketing start
2014-07-30
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
68071-2786-12025-01-30C16284748780-12cef2736-955d-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 Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2786-1Losartan Potassium120 in 1 BOTTLETABLET, FILM COATED1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2786LOSARTAN POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220712_e389a6d7-085c-2499-e053-2995a90aff0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNe389a6d7-085c-2499-e053-2995a90aff0e1
979480losartan potassium 100 MG Oral TabletSCDe389a6d7-085c-2499-e053-2995a90aff0e1
979480Losartan K+ 100 MG Oral TabletSYe389a6d7-085c-2499-e053-2995a90aff0e1
979480Losartan Pot 100 MG Oral TabletSYe389a6d7-085c-2499-e053-2995a90aff0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2786-168071278601120 TABLET, FILM COATED in 1 BOTTLE (68071-2786-1) 2022-07-110000-00-00NoNoCurrent