FDA.reportPublic FDA data

Losartan Potassium

Product NDC
50090-5480
11-digit product format
500905480
Labeler code
50090
Product ID
50090-5480_e956cb01-a44e-4855-9359-ce5787862311
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5480-0Losartan Potassium30 in 1 BOTTLETABLET3011
50090-5480-1Losartan Potassium90 in 1 BOTTLETABLET9011
50090-5480-2Losartan Potassium100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5480-0EA - Each50090-548013ee0863-1566-4055-9141-f4bedab78cb512022-12-07
50090-5480-1EA - Each50090-5480874da953-1b66-4e06-8761-d75d62dc754012022-12-07
50090-5480-2EA - Each50090-54803b0ad37e-7ec7-4fd7-84c7-5c6a33acc33f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5480LOSARTAN POTASSIUM TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 3 package rows20230317_0e0a06f3-b8bd-4178-a519-ed80362e33c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSN0e0a06f3-b8bd-4178-a519-ed80362e33c211
979492losartan potassium 50 MG Oral TabletSCD0e0a06f3-b8bd-4178-a519-ed80362e33c211
979492Losartan K+ 50 MG Oral TabletSY0e0a06f3-b8bd-4178-a519-ed80362e33c211
979492Losartan Pot 50 MG Oral TabletSY0e0a06f3-b8bd-4178-a519-ed80362e33c211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5480-05009054800030 TABLET in 1 BOTTLE (50090-5480-0) 30 tablet2021-03-080000-00-00NoNoCurrent
50090-5480-15009054800190 TABLET in 1 BOTTLE (50090-5480-1) 90 tablet2021-09-200000-00-00NoNoCurrent
50090-5480-250090548002100 TABLET in 1 BOTTLE (50090-5480-2) 100 tablet2023-03-09NoNoHistorical