FDA.reportPublic FDA data

Losartan Potassium

Product NDC
53002-1638
11-digit product format
530021638
Labeler code
53002
Product ID
53002-1638_35e18be5-5853-4224-b796-d6c37a794e54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK 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
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
53002-1638-02025-01-30C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-32025-01-30C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-92025-01-30C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-02023-06-07C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-32023-06-07C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-92023-06-07C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-02023-01-30C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-32023-01-30C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-92023-01-30C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-02020-12-15C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-32020-12-15C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-92020-12-15C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-02020-01-31C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-32020-01-31C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-92020-01-31C16284748780-19d75b9d0-64b4-f424-e053-dadaa90a57ceThese 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
53002-1638-0Losartan Potassium100 in 1 BOTTLETABLET, FILM COATED1009
53002-1638-3Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED309
53002-1638-9Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1638LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]9Legacy NDC, 3 package rows20230609_eea53209-8c3e-430a-8366-e17d5da559e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNeea53209-8c3e-430a-8366-e17d5da559e59
979485losartan potassium 25 MG Oral TabletPSNeea53209-8c3e-430a-8366-e17d5da559e59
979492losartan potassium 50 MG Oral TabletPSNeea53209-8c3e-430a-8366-e17d5da559e59
979480losartan potassium 100 MG Oral TabletSCDeea53209-8c3e-430a-8366-e17d5da559e59
979485losartan potassium 25 MG Oral TabletSCDeea53209-8c3e-430a-8366-e17d5da559e59
979492losartan potassium 50 MG Oral TabletSCDeea53209-8c3e-430a-8366-e17d5da559e59
979480Losartan K+ 100 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979485Losartan K+ 25 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979492Losartan K+ 50 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979480Losartan Pot 100 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979485Losartan Pot 25 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59
979492Losartan Pot 50 MG Oral TabletSYeea53209-8c3e-430a-8366-e17d5da559e59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1638-053002163800100 TABLET, FILM COATED in 1 BOTTLE (53002-1638-0) 2017-09-010000-00-00NoNoCurrent
53002-1638-35300216380330 TABLET, FILM COATED in 1 BOTTLE (53002-1638-3) 2017-09-010000-00-00NoNoCurrent
53002-1638-95300216380990 TABLET, FILM COATED in 1 BOTTLE (53002-1638-9) 2017-09-010000-00-00NoNoCurrent