FDA.reportPublic FDA data

Losartan Potassium

Product NDC
70518-0718
11-digit product format
705180718
Labeler code
70518
Product ID
70518-0718_48331991-73eb-f827-e063-6394a90a43ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090083
Marketing category
ANDA
Marketing start
2017-08-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0718-0Losartan Potassium30 in 1 BLISTER PACKTABLET, FILM COATED3019
70518-0718-1Losartan Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9019
70518-0718-2Losartan Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3019
70518-0718-3Losartan Potassium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0718LOSARTAN POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 4 package rows20250429_25c93638-7016-47d2-a57c-e4a5245ca41b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN25c93638-7016-47d2-a57c-e4a5245ca41b19
979480losartan potassium 100 MG Oral TabletSCD25c93638-7016-47d2-a57c-e4a5245ca41b19
979480Losartan K+ 100 MG Oral TabletSY25c93638-7016-47d2-a57c-e4a5245ca41b19
979480Losartan Pot 100 MG Oral TabletSY25c93638-7016-47d2-a57c-e4a5245ca41b19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0718-07051807180030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0718-0) 2017-08-300000-00-00NoNoCurrent
70518-0718-17051807180190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0718-1) 2018-07-200000-00-00NoNoCurrent
70518-0718-27051807180230 in 1 BOTTLE, PLASTICHistorical
70518-0718-370518071803100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0718-3) 2025-03-20NoNoHistorical