FDA.reportPublic FDA data

Losartan Potassium

Product NDC
50090-5626
11-digit product format
500905626
Labeler code
50090
Product ID
50090-5626_37a55ac8-2482-4979-8992-de8108d1b129
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078232
Marketing category
ANDA
Marketing start
2017-11-01
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
50090-5626-02023-02-06C16284748780-1f386c649-a040-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS USP safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS USP. LOSARTAN POTASSIUM tablets USP, for oral use Initial U.S. Approval: 1995
50090-5626-12023-02-06C16284748780-1f386c649-a040-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS USP safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS USP. LOSARTAN POTASSIUM tablets USP, for oral use Initial U.S. Approval: 1995
50090-5626-02023-01-30C16284748780-1f386c649-a040-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS USP safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS USP. LOSARTAN POTASSIUM tablets USP, for oral use Initial U.S. Approval: 1995
50090-5626-12023-01-30C16284748780-1f386c649-a040-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS USP safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS USP. LOSARTAN POTASSIUM tablets USP, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5626-0Losartan Potassium30 in 1 BOTTLETABLET307
50090-5626-1Losartan Potassium90 in 1 BOTTLETABLET907
50090-5626-2Losartan Potassium100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5626-0EA - Each50090-56268af4d83c-721b-4bd5-bd41-2a5f6c3b805b12022-06-06
50090-5626-1EA - Each50090-5626498dd9f8-127e-4f2c-81f8-101c4b1934d712022-06-06
50090-5626-2EA - Each50090-5626183fc350-4cb3-4ced-a1d9-de7208ef891a12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5626LOSARTAN POTASSIUM TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 3 package rows20241017_7a945396-dd71-4b16-bfab-947982407f36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN7a945396-dd71-4b16-bfab-947982407f367
979485losartan potassium 25 MG Oral TabletSCD7a945396-dd71-4b16-bfab-947982407f367
979485Losartan K+ 25 MG Oral TabletSY7a945396-dd71-4b16-bfab-947982407f367
979485Losartan Pot 25 MG Oral TabletSY7a945396-dd71-4b16-bfab-947982407f367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5626-05009056260030 TABLET in 1 BOTTLE (50090-5626-0) 30 tablet2021-09-010000-00-00NoNoCurrent
50090-5626-15009056260190 TABLET in 1 BOTTLE (50090-5626-1) 90 tablet2021-09-010000-00-00NoNoCurrent
50090-5626-250090562602100 TABLET in 1 BOTTLE (50090-5626-2) 100 tablet2023-03-09NoNoHistorical