FDA.reportPublic FDA data

Losartan Potassium

Product NDC
50090-3403
11-digit product format
500903403
Labeler code
50090
Product ID
50090-3403_908adc3a-3c4d-4905-906a-386b2eb708aa
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
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
50090-3403-02023-02-07C16284748780-1f386c64a-05da-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
50090-3403-12023-02-07C16284748780-1f386c64a-05da-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
50090-3403-02023-01-30C16284748780-1f386c64a-05da-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
50090-3403-12023-01-30C16284748780-1f386c64a-05da-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
50090-3403-0Losartan Potassium90 in 1 BOTTLETABLET905
50090-3403-1Losartan Potassium30 in 1 BOTTLE, PLASTICTABLET305
50090-3403-2Losartan Potassium100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3403-0EA - Each50090-340377ed2937-8fd5-456d-a984-fdbca9cf790c12019-05-02
50090-3403-1EA - Each50090-3403e98eab76-5b81-4880-b0ec-db43426e128f12019-05-02
50090-3403-2EA - Each50090-3403a7448841-1162-4f8f-8b46-9f816069a10512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3403LOSARTAN POTASSIUM TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20230317_679be0b9-bb60-4970-ad50-0041a6d67bf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN679be0b9-bb60-4970-ad50-0041a6d67bf85
979480losartan potassium 100 MG Oral TabletSCD679be0b9-bb60-4970-ad50-0041a6d67bf85
979480Losartan K+ 100 MG Oral TabletSY679be0b9-bb60-4970-ad50-0041a6d67bf85
979480Losartan Pot 100 MG Oral TabletSY679be0b9-bb60-4970-ad50-0041a6d67bf85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3403-05009034030090 TABLET in 1 BOTTLE (50090-3403-0) 90 tablet2018-03-150000-00-00NoNoCurrent
50090-3403-15009034030130 TABLET in 1 BOTTLE, PLASTIC (50090-3403-1) 30 tablet2017-11-010000-00-00NoNoCurrent
50090-3403-250090340302100 TABLET in 1 BOTTLE (50090-3403-2) 100 tablet2023-03-09NoNoHistorical