FDA.reportPublic FDA data

Losartan Potassium

Product NDC
50090-4645
11-digit product format
500904645
Labeler code
50090
Product ID
50090-4645_b26e74c0-59a7-4527-9bc2-0a8b7562a05a
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4645-0Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED309
50090-4645-1Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED909
50090-4645-2Losartan Potassium100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4645-0EA - Each50090-4645e3a7a199-0e18-4de2-90a2-a657d6f38b3112021-08-05
50090-4645-1EA - Each50090-464546a8cde9-c96d-4510-8f76-82111b22e81412022-01-06
50090-4645-2EA - Each50090-46455d33bc35-454a-4abc-be57-6989aaec7f7a12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4645LOSARTAN POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 3 package rows20231216_54e902e6-d443-484a-bed1-e2669656b513.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN54e902e6-d443-484a-bed1-e2669656b5139
979485losartan potassium 25 MG Oral TabletSCD54e902e6-d443-484a-bed1-e2669656b5139
979485Losartan K+ 25 MG Oral TabletSY54e902e6-d443-484a-bed1-e2669656b5139
979485Losartan Pot 25 MG Oral TabletSY54e902e6-d443-484a-bed1-e2669656b5139

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4645-05009046450030 TABLET, FILM COATED in 1 BOTTLE (50090-4645-0) 2019-10-240000-00-00NoNoCurrent
50090-4645-15009046450190 TABLET, FILM COATED in 1 BOTTLE (50090-4645-1) 2019-10-240000-00-00NoNoCurrent
50090-4645-250090464502100 TABLET, FILM COATED in 1 BOTTLE (50090-4645-2) 2023-12-07NoNoCurrent