FDA.reportPublic FDA data

Losartan Potassium

Product NDC
68788-4007
11-digit product format
687884007
Labeler code
68788
Product ID
68788-4007_94eb89aa-296f-4e8f-a077-30a1be01ad52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091497
Marketing category
ANDA
Marketing start
2025-08-08
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
68788-4007-1Losartan Potassium100 in 1 BOTTLETABLET, FILM COATED1001
68788-4007-3Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED301
68788-4007-5Losartan Potassium50 in 1 BOTTLETABLET, FILM COATED501
68788-4007-6Losartan Potassium60 in 1 BOTTLETABLET, FILM COATED601
68788-4007-9Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4007-1EA - Each68788-4007647a58d9-2cdc-4786-8d34-f8db10e152b912025-11-13
68788-4007-3EA - Each68788-4007d6662f3e-8506-42d7-9119-919b82a7304f12025-11-13
68788-4007-5EA - Each68788-40076084ba91-92d2-4ae4-a3c6-01680aadd1fd12025-11-13
68788-4007-6EA - Each68788-400724cb4633-bd72-4ff4-abdc-72ee8c451cd012025-11-13
68788-4007-9EA - Each68788-400734126766-4941-47e2-985e-3da4f121506d12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN94eb89aa-296f-4e8f-a077-30a1be01ad521
979485losartan potassium 25 MG Oral TabletSCD94eb89aa-296f-4e8f-a077-30a1be01ad521
979485Losartan K+ 25 MG Oral TabletSY94eb89aa-296f-4e8f-a077-30a1be01ad521
979485Losartan Pot 25 MG Oral TabletSY94eb89aa-296f-4e8f-a077-30a1be01ad521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4007-168788400701100 TABLET, FILM COATED in 1 BOTTLE (68788-4007-1) 2025-08-08NoNoHistorical
68788-4007-36878840070330 TABLET, FILM COATED in 1 BOTTLE (68788-4007-3) 2025-08-08NoNoHistorical
68788-4007-56878840070550 TABLET, FILM COATED in 1 BOTTLE (68788-4007-5) 2025-08-08NoNoHistorical
68788-4007-66878840070660 TABLET, FILM COATED in 1 BOTTLE (68788-4007-6) 2025-08-08NoNoHistorical
68788-4007-96878840070990 TABLET, FILM COATED in 1 BOTTLE (68788-4007-9) 2025-08-08NoNoHistorical