FDA.reportPublic FDA data

LOSARTAN POTASSIUM

Product NDC
71205-598
11-digit product format
712050598
Labeler code
71205
Product ID
71205-598_f260f7c5-a55b-4294-ae02-2586929e24c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOSARTAN POTASSIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090382
Marketing category
ANDA
Marketing start
2019-10-09
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
Brand name suffix
50 mg
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
71205-598-30LOSARTAN POTASSIUM50 mg30 in 1 BOTTLETABLET, FILM COATED301
71205-598-60LOSARTAN POTASSIUM50 mg60 in 1 BOTTLETABLET, FILM COATED601
71205-598-90LOSARTAN POTASSIUM50 mg90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-598-90EA - Each71205-5980e6cb702-ff77-4c3c-9e79-feb55661a73412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-598LOSARTAN POTASSIUM 50 MG (LOSARTAN POTASSIUM) TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20210818_f260f7c5-a55b-4294-ae02-2586929e24c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSNf260f7c5-a55b-4294-ae02-2586929e24c91
979492losartan potassium 50 MG Oral TabletSCDf260f7c5-a55b-4294-ae02-2586929e24c91
979492Losartan K+ 50 MG Oral TabletSYf260f7c5-a55b-4294-ae02-2586929e24c91
979492Losartan Pot 50 MG Oral TabletSYf260f7c5-a55b-4294-ae02-2586929e24c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-598-307120505983030 TABLET, FILM COATED in 1 BOTTLE (71205-598-30) 2021-08-100000-00-00NoNoCurrent
71205-598-607120505986060 TABLET, FILM COATED in 1 BOTTLE (71205-598-60) 2021-08-100000-00-00NoNoCurrent
71205-598-907120505989090 TABLET, FILM COATED in 1 BOTTLE (71205-598-90) 2021-08-100000-00-00NoNoCurrent