FDA.reportPublic FDA data

Losartan Potassium

Product NDC
51655-918
11-digit product format
516550918
Labeler code
51655
Product ID
51655-918_4bbd427d-5f43-034a-e063-6294a90ab09b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090083
Marketing category
ANDA
Marketing start
2022-03-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A
Rxcui979485

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
51655-918-262026-01-29C16284748780-149896155-bd95-586f-e063-e6dba90add90These 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
51655-918-522026-01-29C16284748780-149896155-bd95-586f-e063-e6dba90add90These 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
51655-918-26Losartan Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
51655-918-52Losartan Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-918LOSARTAN POTASSIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 2 package rows20231219_d9dfae69-9ce7-0c6b-e053-2a95a90aace8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSNd9dfae69-9ce7-0c6b-e053-2a95a90aace84
979485losartan potassium 25 MG Oral TabletSCDd9dfae69-9ce7-0c6b-e053-2a95a90aace84
979485Losartan K+ 25 MG Oral TabletSYd9dfae69-9ce7-0c6b-e053-2a95a90aace84
979485Losartan Pot 25 MG Oral TabletSYd9dfae69-9ce7-0c6b-e053-2a95a90aace84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-918-265165509182690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-918-26) 2022-03-020000-00-00NoNoCurrent
51655-918-525165509185230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-918-52) 2022-03-020000-00-00NoNoCurrent