FDA.reportPublic FDA data

Losartan Potassium

Product NDC
70010-743
11-digit product format
700100743
Labeler code
70010
Product ID
70010-743_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
100 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 POTASSIUM100 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
70010-743-03Losartan Potassium30 in 1 BOTTLETABLET302
70010-743-09Losartan Potassium90 in 1 BOTTLETABLET902
70010-743-10Losartan Potassium1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-743-03EA - Each70010-74377c20ef9-7c50-449c-afa9-c746adf2698912023-06-06
70010-743-09EA - Each70010-7434ca67034-9ac8-4554-be05-625a0179bb2e12023-06-06
70010-743-10EA - Each70010-74312aa064e-bd74-4f8c-90d0-e1fde1f7be9412023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-743LOSARTAN 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
70010-743-037001007430330 TABLET in 1 BOTTLE (70010-743-03) 30 tablet2023-03-08NoNoHistorical
70010-743-097001007430990 TABLET in 1 BOTTLE (70010-743-09) 90 tablet2023-03-08NoNoHistorical
70010-743-10700100743101000 TABLET in 1 BOTTLE (70010-743-10) 1000 tablet2023-03-08NoNoHistorical