FDA.reportPublic FDA data

Losartan Potassium

Product NDC
51655-791
11-digit product format
516550791
Labeler code
51655
Product ID
51655-791_4ba8511f-45d2-25b8-e063-6294a90a1b85
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
2022-01-18
Substance
LOSARTAN POTASSIUM
Active strength
100 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 POTASSIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A
Rxcui979480

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
51655-791-262026-01-29C16284748780-149896155-a2f1-586f-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
51655-791-522026-01-29C16284748780-149896155-a2f1-586f-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
51655-791-26Losartan Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906
51655-791-52Losartan Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-791LOSARTAN POTASSIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1Current NDC, 2 package rows20230221_d9ced981-d791-6600-e053-2995a90ace3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNd9ced981-d791-6600-e053-2995a90ace3b6
979480losartan potassium 100 MG Oral TabletSCDd9ced981-d791-6600-e053-2995a90ace3b6
979480Losartan K+ 100 MG Oral TabletSYd9ced981-d791-6600-e053-2995a90ace3b6
979480Losartan Pot 100 MG Oral TabletSYd9ced981-d791-6600-e053-2995a90ace3b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-791-265165507912690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-791-26) 2022-01-20NoNoHistorical
51655-791-525165507915230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-791-52) 2022-01-18NoNoHistorical