FDA.reportPublic FDA data

LOSARTAN POTASSIUM

Product NDC
50090-5406
11-digit product format
500905406
Labeler code
50090
Product ID
50090-5406_07311a6c-2992-4abe-ae6c-768bcc45b5ea
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
25 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
50090-5406-02023-01-30C16284748780-1f386c649-b1e4-0266-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
50090-5406-12023-01-30C16284748780-1f386c649-b1e4-0266-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
50090-5406-0LOSARTAN POTASSIUM25 mg30 in 1 BOTTLETABLET, FILM COATED303
50090-5406-1LOSARTAN POTASSIUM25 mg90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5406-1EA - Each50090-54067329e803-89ff-4b95-8695-c471e56e052a12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5406LOSARTAN POTASSIUM 25 MG (LOSARTAN POTASSIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210303_7b3f390e-6cc5-431b-9595-17b7bbd0c739.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN7b3f390e-6cc5-431b-9595-17b7bbd0c7393
979485losartan potassium 25 MG Oral TabletSCD7b3f390e-6cc5-431b-9595-17b7bbd0c7393
979485Losartan K+ 25 MG Oral TabletSY7b3f390e-6cc5-431b-9595-17b7bbd0c7393
979485Losartan Pot 25 MG Oral TabletSY7b3f390e-6cc5-431b-9595-17b7bbd0c7393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5406-05009054060030 TABLET, FILM COATED in 1 BOTTLE (50090-5406-0) 2020-12-100000-00-00NoNoCurrent
50090-5406-15009054060190 TABLET, FILM COATED in 1 BOTTLE (50090-5406-1) 2020-12-100000-00-00NoNoCurrent