FDA.reportPublic FDA data

Losartan Potassium

Product NDC
42708-113
11-digit product format
427080113
Labeler code
42708
Product ID
42708-113_465371fb-4188-3849-e063-6294a90a7ac6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA203835
Marketing category
ANDA
Marketing start
2015-08-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan Potassium
Listing expiration
2026-12-31

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
42708-113-302021-03-15C16284748780-1ba0f9c33-4887-a910-e053-dadaa90a0b85These 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
42708-113-302021-01-29C16284748780-1ba0f9c33-4887-a910-e053-dadaa90a0b85These 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
42708-113-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-113LOSARTAN POTASSIUM TABLET, FILM COATED [QPHARMA INC]4Current NDC, Legacy NDC, 1 package rows20241204_0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d738.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSN0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d7385
979492losartan potassium 50 MG Oral TabletSCD0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d7385
979492Losartan K+ 50 MG Oral TabletSY0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d7385
979492Losartan Pot 50 MG Oral TabletSY0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d7385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-113-304270801133030 TABLET, FILM COATED in 1 BOTTLE (42708-113-30) 2019-11-180000-00-00YesNoCurrent