Losartan Potassium

Product NDC
53002-4643
11-digit product format
530024643
Labeler code
53002
Product ID
53002-4643_aa68c997-f2eb-4906-82e9-9f75d486647f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA203835
Marketing category
ANDA
Marketing start
2015-08-19
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
53002-4643-32025-01-30C16284748780-1f386c649-c97a-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
53002-4643-92025-01-30C16284748780-1f386c649-c97a-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
53002-4643-32023-06-07C16284748780-1f386c649-c97a-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
53002-4643-92023-06-07C16284748780-1f386c649-c97a-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
53002-4643-32023-01-30C16284748780-1f386c649-c97a-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
53002-4643-92023-01-30C16284748780-1f386c649-c97a-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
53002-4643-3Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED303
53002-4643-9Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4643LOSARTAN POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_90ff8d06-18af-4756-891e-0a029bcc69e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSN90ff8d06-18af-4756-891e-0a029bcc69e63
979492losartan potassium 50 MG Oral TabletSCD90ff8d06-18af-4756-891e-0a029bcc69e63
979492Losartan K+ 50 MG Oral TabletSY90ff8d06-18af-4756-891e-0a029bcc69e63
979492Losartan Pot 50 MG Oral TabletSY90ff8d06-18af-4756-891e-0a029bcc69e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-4643-35300246430330 TABLET, FILM COATED in 1 BOTTLE (53002-4643-3) 2020-01-010000-00-00NoNoCurrent
53002-4643-95300246430990 TABLET, FILM COATED in 1 BOTTLE (53002-4643-9) 2020-01-010000-00-00NoNoCurrent