FDA.reportPublic FDA data

Losartan Potassium

Product NDC
42708-125
11-digit product format
427080125
Labeler code
42708
Product ID
42708-125_46538946-6c57-dce2-e063-6394a90ae990
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA090083
Marketing category
ANDA
Marketing start
2010-10-06
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
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 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
42708-125-302021-03-15C16284748780-1ba0f9c33-2b5d-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
42708-125-302021-01-29C16284748780-1ba0f9c33-2b5d-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
42708-125-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-125LOSARTAN POTASSIUM TABLET, FILM COATED [QPHARMA INC]6Current NDC, Legacy NDC, 1 package rows20241123_16a6a582-eb4d-41bc-9d49-fc1d4117b29a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN16a6a582-eb4d-41bc-9d49-fc1d4117b29a7
979485losartan potassium 25 MG Oral TabletSCD16a6a582-eb4d-41bc-9d49-fc1d4117b29a7
979485Losartan K+ 25 MG Oral TabletSY16a6a582-eb4d-41bc-9d49-fc1d4117b29a7
979485Losartan Pot 25 MG Oral TabletSY16a6a582-eb4d-41bc-9d49-fc1d4117b29a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-125-304270801253030 TABLET, FILM COATED in 1 BOTTLE (42708-125-30) 2018-05-230000-00-00YesNoCurrent