FDA.reportPublic FDA data

Losartan Potassium

Product NDC
68071-5114
11-digit product format
680715114
Labeler code
68071
Product ID
68071-5114_1b46a65e-1fc6-d616-e063-6394a90a12b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5114-32024-06-19C16284748780-1ba0f9c33-5339-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, USP for oral use Initial U.S. Approval: 1995
68071-5114-32023-01-30C16284748780-1ba0f9c33-5339-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, USP for oral use Initial U.S. Approval: 1995
68071-5114-32021-02-22C16284748780-1ba0f9c33-5339-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, USP for oral use Initial U.S. Approval: 1995
68071-5114-32021-01-29C16284748780-1ba0f9c33-5339-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, USP for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5114-3Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5114LOSARTAN POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240621_97a50b38-f5b3-0a96-e053-2995a90a345f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN97a50b38-f5b3-0a96-e053-2995a90a345f3
979485losartan potassium 25 MG Oral TabletSCD97a50b38-f5b3-0a96-e053-2995a90a345f3
979485Losartan K+ 25 MG Oral TabletSY97a50b38-f5b3-0a96-e053-2995a90a345f3
979485Losartan Pot 25 MG Oral TabletSY97a50b38-f5b3-0a96-e053-2995a90a345f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5114-36807151140330 TABLET, FILM COATED in 1 BOTTLE (68071-5114-3) 2019-11-180000-00-00NoNoCurrent