FDA.reportPublic FDA data

Losartan Potassium

Product NDC
71205-226
11-digit product format
712050226
Labeler code
71205
Product ID
71205-226_61dad858-613a-4add-a885-b63adc2048ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091497
Marketing category
ANDA
Marketing start
2011-06-01
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
71205-226-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED303
71205-226-60Losartan Potassium60 in 1 BOTTLETABLET, FILM COATED603
71205-226-90Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-226-30EA - Each71205-2260a291cbb-dd91-4d5a-9260-1f6e44ffbc0312019-04-11
71205-226-90EA - Each71205-2268155ba5b-0ab4-4eb2-9f21-3770f916c8d812025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-226LOSARTAN POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20220726_1b3c03e8-da8e-4c25-a493-118e760a003b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN1b3c03e8-da8e-4c25-a493-118e760a003b3
979485losartan potassium 25 MG Oral TabletSCD1b3c03e8-da8e-4c25-a493-118e760a003b3
979485Losartan K+ 25 MG Oral TabletSY1b3c03e8-da8e-4c25-a493-118e760a003b3
979485Losartan Pot 25 MG Oral TabletSY1b3c03e8-da8e-4c25-a493-118e760a003b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-226-307120502263030 TABLET, FILM COATED in 1 BOTTLE (71205-226-30) 2019-02-010000-00-00NoNoCurrent
71205-226-607120502266060 TABLET, FILM COATED in 1 BOTTLE (71205-226-60) 2019-02-010000-00-00NoNoCurrent
71205-226-907120502269090 TABLET, FILM COATED in 1 BOTTLE (71205-226-90) 2019-02-010000-00-00NoNoCurrent