FDA.reportPublic FDA data

Losartan Potassium

Product NDC
70010-742
11-digit product format
700100742
Labeler code
70010
Product ID
70010-742_451da3de-077d-522d-e063-6394a90a3537
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan
Dosage form
TABLET
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA215959
Marketing category
ANDA
Marketing start
2023-03-08
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
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 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
70010-742-03Losartan Potassium30 in 1 BOTTLETABLET302
70010-742-09Losartan Potassium90 in 1 BOTTLETABLET902
70010-742-10Losartan Potassium1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-742-03EA - Each70010-7424042f8a8-7dc6-4ed7-966b-ab404f9301b312023-06-06
70010-742-09EA - Each70010-742f1c95351-4598-464e-8635-8ab9cf40ec2c12023-06-06
70010-742-10EA - Each70010-7423433ab8d-b052-4200-8da9-b53f775a457e12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-742LOSARTAN POTASSIUM (LOSARTAN) TABLET [GRANULES PHARMACEUTICALS INC.]1Current NDC, 3 package rows20230310_ca012edc-923d-4ada-a261-db82b71b3c4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNca012edc-923d-4ada-a261-db82b71b3c4f2
979485losartan potassium 25 MG Oral TabletPSNca012edc-923d-4ada-a261-db82b71b3c4f2
979492losartan potassium 50 MG Oral TabletPSNca012edc-923d-4ada-a261-db82b71b3c4f2
979480losartan potassium 100 MG Oral TabletSCDca012edc-923d-4ada-a261-db82b71b3c4f2
979485losartan potassium 25 MG Oral TabletSCDca012edc-923d-4ada-a261-db82b71b3c4f2
979492losartan potassium 50 MG Oral TabletSCDca012edc-923d-4ada-a261-db82b71b3c4f2
979480Losartan K+ 100 MG Oral TabletSYca012edc-923d-4ada-a261-db82b71b3c4f2
979485Losartan K+ 25 MG Oral TabletSYca012edc-923d-4ada-a261-db82b71b3c4f2
979492Losartan K+ 50 MG Oral TabletSYca012edc-923d-4ada-a261-db82b71b3c4f2
979480Losartan Pot 100 MG Oral TabletSYca012edc-923d-4ada-a261-db82b71b3c4f2
979485Losartan Pot 25 MG Oral TabletSYca012edc-923d-4ada-a261-db82b71b3c4f2
979492Losartan Pot 50 MG Oral TabletSYca012edc-923d-4ada-a261-db82b71b3c4f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-742-037001007420330 TABLET in 1 BOTTLE (70010-742-03) 30 tablet2023-03-08NoNoHistorical
70010-742-097001007420990 TABLET in 1 BOTTLE (70010-742-09) 90 tablet2023-03-08NoNoHistorical
70010-742-10700100742101000 TABLET in 1 BOTTLE (70010-742-10) 1000 tablet2023-03-08NoNoHistorical