FDA.reportPublic FDA data

Losortan Potassium

Product NDC
71335-1644
11-digit product format
713351644
Labeler code
71335
Product ID
71335-1644_b2ed13ec-023f-406d-9621-6d403cba36b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078243
Marketing category
ANDA
Marketing start
2010-10-04
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Losortan Potassium
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1644-1Losortan Potassium90 in 1 BOTTLETABLET, FILM COATED906
71335-1644-2Losortan Potassium30 in 1 BOTTLETABLET, FILM COATED306
71335-1644-3Losortan Potassium60 in 1 BOTTLETABLET, FILM COATED606
71335-1644-4Losortan Potassium100 in 1 BOTTLETABLET, FILM COATED1006
71335-1644-5Losortan Potassium10 in 1 BOTTLETABLET, FILM COATED106
71335-1644-6Losortan Potassium7 in 1 BOTTLETABLET, FILM COATED76

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1644LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 6 package rows20250402_1b285c10-f468-4d87-b36d-79047f686c58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN1b285c10-f468-4d87-b36d-79047f686c586
979485losartan potassium 25 MG Oral TabletSCD1b285c10-f468-4d87-b36d-79047f686c586
979485Losartan K+ 25 MG Oral TabletSY1b285c10-f468-4d87-b36d-79047f686c586
979485Losartan Pot 25 MG Oral TabletSY1b285c10-f468-4d87-b36d-79047f686c586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1644-17133516440190 TABLET, FILM COATED in 1 BOTTLE (71335-1644-1) 2020-07-090000-00-00NoNoCurrent
71335-1644-27133516440230 TABLET, FILM COATED in 1 BOTTLE (71335-1644-2) 2020-07-010000-00-00NoNoCurrent
71335-1644-37133516440360 TABLET, FILM COATED in 1 BOTTLE (71335-1644-3) 2020-09-090000-00-00NoNoCurrent
71335-1644-471335164404100 TABLET, FILM COATED in 1 BOTTLE (71335-1644-4) 2022-02-140000-00-00NoNoCurrent
71335-1644-57133516440510 TABLET, FILM COATED in 1 BOTTLE (71335-1644-5) 2022-02-140000-00-00NoNoCurrent
71335-1644-6713351644067 TABLET, FILM COATED in 1 BOTTLE (71335-1644-6) 2022-02-14NoNoHistorical