FDA.reportPublic FDA data

LOSARTAN POTASSIUM

Product NDC
51655-418
11-digit product format
516550418
Labeler code
51655
Product ID
51655-418_4b431156-5b19-0818-e063-6294a90a2b61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOSARTAN POTASSIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090382
Marketing category
ANDA
Marketing start
2020-07-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LOSARTAN POTASSIUM
Brand name suffix
50 mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A
Rxcui979492

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
51655-418-262023-10-30C16284748780-1f386c64a-2108-0266-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
51655-418-262023-01-30C16284748780-1f386c64a-2108-0266-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
51655-418-26LOSARTAN POTASSIUM50 mg90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-418LOSARTAN POTASSIUM 50 MG (LOSARTAN POTASSIUM) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20241220_c29d999d-adc9-6c66-e053-2995a90a1fc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSNc29d999d-adc9-6c66-e053-2995a90a1fc34
979492losartan potassium 50 MG Oral TabletSCDc29d999d-adc9-6c66-e053-2995a90a1fc34
979492Losartan K+ 50 MG Oral TabletSYc29d999d-adc9-6c66-e053-2995a90a1fc34
979492Losartan Pot 50 MG Oral TabletSYc29d999d-adc9-6c66-e053-2995a90a1fc34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-418-265165504182690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-418-26) 2020-07-150000-00-00NoNoCurrent