FDA.reportPublic FDA data

Losartan Potassium

Product NDC
70518-3489
11-digit product format
705183489
Labeler code
70518
Product ID
70518-3489_4af408fb-5d31-b4a7-e063-6294a90a4bb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091497
Marketing category
ANDA
Marketing start
2022-08-22
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
Losartan 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
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3489-0Losartan Potassium30 in 1 BLISTER PACKTABLET, FILM COATED306
70518-3489-1Losartan Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906
70518-3489-2Losartan Potassium30 in 1 BLISTER PACKTABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3489LOSARTAN POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 3 package rows20241121_e136356b-e4d2-4e00-a409-35825c5637c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSNe136356b-e4d2-4e00-a409-35825c5637c96
979485losartan potassium 25 MG Oral TabletSCDe136356b-e4d2-4e00-a409-35825c5637c96
979485Losartan K+ 25 MG Oral TabletSYe136356b-e4d2-4e00-a409-35825c5637c96
979485Losartan Pot 25 MG Oral TabletSYe136356b-e4d2-4e00-a409-35825c5637c96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3489-07051834890030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3489-0) 2022-08-220000-00-00NoNoCurrent
70518-3489-17051834890190 in 1 BOTTLE, PLASTICHistorical
70518-3489-27051834890230 TABLET, FILM COATED in 1 BLISTER PACK (70518-3489-2) 2026-02-15NoNoCurrent