FDA.reportPublic FDA data

Losartan Potassium

Product NDC
50090-4914
11-digit product format
500904914
Labeler code
50090
Product ID
50090-4914_2c965949-e86b-43a2-a847-c54ee187280b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203835
Marketing category
ANDA
Marketing start
2015-08-19
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
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 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
50090-4914-02023-02-07C16284748780-1f386c649-d7a5-0266-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
50090-4914-02023-01-30C16284748780-1f386c649-d7a5-0266-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
50090-4914-0Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4914LOSARTAN POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20240827_f68fd1a2-1cbf-47c8-b8c4-df49cf17540e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNf68fd1a2-1cbf-47c8-b8c4-df49cf17540e7
979480losartan potassium 100 MG Oral TabletSCDf68fd1a2-1cbf-47c8-b8c4-df49cf17540e7
979480Losartan K+ 100 MG Oral TabletSYf68fd1a2-1cbf-47c8-b8c4-df49cf17540e7
979480Losartan Pot 100 MG Oral TabletSYf68fd1a2-1cbf-47c8-b8c4-df49cf17540e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4914-05009049140090 TABLET, FILM COATED in 1 BOTTLE (50090-4914-0) 2020-02-180000-00-00NoNoCurrent