FDA.reportPublic FDA data

Losartan Potassium

Product NDC
51655-795
11-digit product format
516550795
Labeler code
51655
Product ID
51655-795_4ba89236-9807-69a6-e063-6394a90a95ab
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
2022-01-19
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
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
51655-795-262026-01-29C16284748780-149896155-c536-586f-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
51655-795-522026-01-29C16284748780-149896155-c536-586f-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
51655-795-26Losartan Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
51655-795-52Losartan Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-795LOSARTAN POTASSIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1Current NDC, 2 package rows20230221_d9de3627-9aa2-65c8-e053-2995a90ab5ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSNd9de3627-9aa2-65c8-e053-2995a90ab5ec4
979492losartan potassium 50 MG Oral TabletSCDd9de3627-9aa2-65c8-e053-2995a90ab5ec4
979492Losartan K+ 50 MG Oral TabletSYd9de3627-9aa2-65c8-e053-2995a90ab5ec4
979492Losartan Pot 50 MG Oral TabletSYd9de3627-9aa2-65c8-e053-2995a90ab5ec4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-795-265165507952690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-795-26) 2022-01-19NoNoCurrent
51655-795-525165507955230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-795-52) 2022-01-20NoNoCurrent