FDA.reportPublic FDA data

Losartan Potassium

Product NDC
53002-2643
11-digit product format
530022643
Labeler code
53002
Product ID
53002-2643_87af9b03-c984-450f-a2dc-39da1776f2c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090467
Marketing category
ANDA
Marketing start
2010-10-06
Marketing end
0000-00-00
Substance
LOSARTAN POTASSIUM
Active strength
50 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-2643-02023-01-30C16284748780-1f386c64a-4074-0266-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 Rx Only Initial U.S. Approval: 1995
53002-2643-32023-01-30C16284748780-1f386c64a-4074-0266-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 Rx Only Initial U.S. Approval: 1995
53002-2643-92023-01-30C16284748780-1f386c64a-4074-0266-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 Rx Only Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2643-0Losartan Potassium100 in 1 BOTTLETABLET1001
53002-2643-3Losartan Potassium30 in 1 BOTTLETABLET301
53002-2643-9Losartan Potassium90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2643LOSARTAN POTASSIUM TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20201225_f08333a1-35d7-446c-9ca2-41b2c4e533d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSNf08333a1-35d7-446c-9ca2-41b2c4e533d81
979492losartan potassium 50 MG Oral TabletSCDf08333a1-35d7-446c-9ca2-41b2c4e533d81
979492Losartan K+ 50 MG Oral TabletSYf08333a1-35d7-446c-9ca2-41b2c4e533d81
979492Losartan Pot 50 MG Oral TabletSYf08333a1-35d7-446c-9ca2-41b2c4e533d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2643-053002264300100 TABLET in 1 BOTTLE (53002-2643-0) 100 tablet2019-01-010000-00-00NoNoCurrent
53002-2643-35300226430330 TABLET in 1 BOTTLE (53002-2643-3) 30 tablet2019-01-010000-00-00NoNoCurrent
53002-2643-95300226430990 TABLET in 1 BOTTLE (53002-2643-9) 90 tablet2019-01-010000-00-00NoNoCurrent