FDA.reportPublic FDA data

Losartan potassium

Product NDC
72205-142
11-digit product format
722050142
Labeler code
72205
Product ID
72205-142_965852b8-5563-4f23-8cd1-a2f82cf16d3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA217396
Marketing category
ANDA
Marketing start
2023-08-14
Substance
LOSARTAN POTASSIUM
Active strength
50 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 POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A
Rxcui979480, 979485, 979492

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
72205-142-30Losartan potassium30 in 1 BOTTLETABLET, FILM COATED303
72205-142-90Losartan potassium90 in 1 BOTTLETABLET, FILM COATED903
72205-142-99Losartan potassium1000 in 1 BOTTLETABLET, FILM COATED10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-142-30EA - Each72205-1427a010424-dd6f-4380-bddc-d8d49ed3fbf112024-01-04
72205-142-90EA - Each72205-14270093236-5178-4afb-8fd5-ccc08b78717912024-01-04
72205-142-99EA - Each72205-1423898e5e3-9de1-4241-b935-6a734d0c6d1b12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-142LOSARTAN POTASSIUM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 3 package rows20230819_5edb843a-66ed-4950-9ed0-393e6a5d7c99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN5edb843a-66ed-4950-9ed0-393e6a5d7c993
979485losartan potassium 25 MG Oral TabletPSN5edb843a-66ed-4950-9ed0-393e6a5d7c993
979492losartan potassium 50 MG Oral TabletPSN5edb843a-66ed-4950-9ed0-393e6a5d7c993
979480losartan potassium 100 MG Oral TabletSCD5edb843a-66ed-4950-9ed0-393e6a5d7c993
979485losartan potassium 25 MG Oral TabletSCD5edb843a-66ed-4950-9ed0-393e6a5d7c993
979492losartan potassium 50 MG Oral TabletSCD5edb843a-66ed-4950-9ed0-393e6a5d7c993
979480Losartan K+ 100 MG Oral TabletSY5edb843a-66ed-4950-9ed0-393e6a5d7c993
979485Losartan K+ 25 MG Oral TabletSY5edb843a-66ed-4950-9ed0-393e6a5d7c993
979492Losartan K+ 50 MG Oral TabletSY5edb843a-66ed-4950-9ed0-393e6a5d7c993
979480Losartan Pot 100 MG Oral TabletSY5edb843a-66ed-4950-9ed0-393e6a5d7c993
979485Losartan Pot 25 MG Oral TabletSY5edb843a-66ed-4950-9ed0-393e6a5d7c993
979492Losartan Pot 50 MG Oral TabletSY5edb843a-66ed-4950-9ed0-393e6a5d7c993

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-142-307220501423030 TABLET, FILM COATED in 1 BOTTLE (72205-142-30) 2023-08-16NoNoCurrent
72205-142-907220501429090 TABLET, FILM COATED in 1 BOTTLE (72205-142-90) 2023-08-16NoNoCurrent
72205-142-99722050142991000 TABLET, FILM COATED in 1 BOTTLE (72205-142-99) 2023-08-16NoNoCurrent