FDA.reportPublic FDA data

Losartan potassium Tablets, 100 mg

Product NDC
59746-335
11-digit product format
597460335
Labeler code
59746
Product ID
59746-335_cfcfa1c5-48d3-4370-aa10-e1d054c1844f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium
Dosage form
TABLET
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA201170
Marketing category
ANDA
Marketing start
2012-09-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan potassium Tablets, 100 mg
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-335-01Losartan potassium Tablets, 100 mg100 in 1 BOTTLETABLET1008
59746-335-10Losartan potassium Tablets, 100 mg1000 in 1 BOTTLETABLET10008
59746-335-30Losartan potassium Tablets, 100 mg30 in 1 BOTTLETABLET308
59746-335-90Losartan potassium Tablets, 100 mg90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-335-10EA - Each59746-335fda35da1-0acf-493e-b0da-f6b6a613f43612014-01-04
59746-335-30EA - Each59746-3356bb7e3d1-5db1-4a4f-bdf8-e1970778995612014-01-04
59746-335-90EA - Each59746-33514300f5a-8966-4cd7-893a-417fbe50877c12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Losartan PotassiumACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
LosartanACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Aluminum OxideINACTIVE INGREDIENTLMI26O6933LOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GLOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Fd&c Blue No. 2INACTIVE INGREDIENTL06K8R7DQKLOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Hydroxypropyl Cellulose (type H)INACTIVE INGREDIENTRFW2ET671PLOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
HypromellosesINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Starch, CornINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-335LOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 4 package rows20190223_1bf520a2-a50e-a6ae-0fdf-9be4e69729c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN04c4ba11-a9bd-4fed-bf14-14214f33f9c2103
979480losartan potassium 100 MG Oral TabletSCD04c4ba11-a9bd-4fed-bf14-14214f33f9c2103
979480Losartan K+ 100 MG Oral TabletSY04c4ba11-a9bd-4fed-bf14-14214f33f9c2103
979480Losartan Pot 100 MG Oral TabletSY04c4ba11-a9bd-4fed-bf14-14214f33f9c2103
979480losartan potassium 100 MG Oral TabletPSN726002cf-2d95-4dac-b1f6-e7f92bb13496101
979480losartan potassium 100 MG Oral TabletSCD726002cf-2d95-4dac-b1f6-e7f92bb13496101
979480Losartan K+ 100 MG Oral TabletSY726002cf-2d95-4dac-b1f6-e7f92bb13496101
979480Losartan Pot 100 MG Oral TabletSY726002cf-2d95-4dac-b1f6-e7f92bb13496101
979480losartan potassium 100 MG Oral TabletPSN1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979485losartan potassium 25 MG Oral TabletPSN1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979492losartan potassium 50 MG Oral TabletPSN1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979480losartan potassium 100 MG Oral TabletSCD1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979485losartan potassium 25 MG Oral TabletSCD1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979492losartan potassium 50 MG Oral TabletSCD1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979480Losartan K+ 100 MG Oral TabletSY1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979485Losartan K+ 25 MG Oral TabletSY1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979492Losartan K+ 50 MG Oral TabletSY1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979480Losartan Pot 100 MG Oral TabletSY1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979485Losartan Pot 25 MG Oral TabletSY1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979492Losartan Pot 50 MG Oral TabletSY1bf520a2-a50e-a6ae-0fdf-9be4e69729c08
979480losartan potassium 100 MG Oral TabletPSN733e4f80-cb7c-498d-ace0-28cade2e55302
979480losartan potassium 100 MG Oral TabletSCD733e4f80-cb7c-498d-ace0-28cade2e55302
979480Losartan K+ 100 MG Oral TabletSY733e4f80-cb7c-498d-ace0-28cade2e55302
979480Losartan Pot 100 MG Oral TabletSY733e4f80-cb7c-498d-ace0-28cade2e55302
979480losartan potassium 100 MG Oral TabletPSN2d1b03bb-2355-baac-e063-6294a90a9b401
979480losartan potassium 100 MG Oral TabletSCD2d1b03bb-2355-baac-e063-6294a90a9b401
979480Losartan K+ 100 MG Oral TabletSY2d1b03bb-2355-baac-e063-6294a90a9b401
979480Losartan Pot 100 MG Oral TabletSY2d1b03bb-2355-baac-e063-6294a90a9b401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-335-0159746033501100 TABLET in 1 BOTTLE (59746-335-01) 100 tablet2012-09-180000-00-00NoNoCurrent
59746-335-10597460335101000 TABLET in 1 BOTTLE (59746-335-10) 1000 tablet2012-09-180000-00-00NoNoCurrent
59746-335-305974603353030 TABLET in 1 BOTTLE (59746-335-30) 30 tablet2012-09-180000-00-00NoNoCurrent
59746-335-905974603359090 TABLET in 1 BOTTLE (59746-335-90) 90 tablet2012-09-180000-00-00NoNoCurrent