FDA.reportPublic FDA data

Losartan Potassium

Product NDC
72789-029
11-digit product format
727890029
Labeler code
72789
Product ID
72789-029_2d58db43-e7d1-439f-e063-6294a90a6043
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA203835
Marketing category
ANDA
Marketing start
2015-08-19
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
72789-029-14Losartan Potassium14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1414
72789-029-30Losartan Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
72789-029-90Losartan Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-029-30EA - Each72789-029d8dabec7-796d-4862-8b0c-15b5f2b4f8f812024-01-04
72789-029-90EA - Each72789-02938dd573e-dbee-45bc-942f-2fb725e6ad3212020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-029LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 3 package rows20250206_1843ee4b-1afc-4992-993a-4b0e03e785fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN1843ee4b-1afc-4992-993a-4b0e03e785fc14
979485losartan potassium 25 MG Oral TabletSCD1843ee4b-1afc-4992-993a-4b0e03e785fc14
979485Losartan K+ 25 MG Oral TabletSY1843ee4b-1afc-4992-993a-4b0e03e785fc14
979485Losartan Pot 25 MG Oral TabletSY1843ee4b-1afc-4992-993a-4b0e03e785fc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-029-147278900291414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-029-14) 2020-09-240000-00-00NoNoCurrent
72789-029-307278900293030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-029-30) 2023-12-06NoNoHistorical
72789-029-907278900299090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-029-90) 2019-11-200000-00-00NoNoCurrent