Losartan potassium

Product NDC
33342-044
11-digit product format
333420044
Labeler code
33342
Product ID
33342-044_81824d1f-61f4-457c-8723-cd43d5429029
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202230
Marketing category
ANDA
Marketing start
2012-05-10
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
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
33342-044-07Losartan potassium30 in 1 BOTTLETABLET, FILM COATED308
33342-044-10Losartan potassium90 in 1 BOTTLETABLET, FILM COATED908
33342-044-12Losartan potassium10 in 1 CARTONTABLET, FILM COATED108
33342-044-12Losartan potassium10 in 1 BLISTER PACKTABLET, FILM COATED108
33342-044-44Losartan potassium1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-044-07EA - Each33342-0443fc1fade-bef3-49aa-9918-1c28b59d250812015-08-04
33342-044-10EA - Each33342-044f1d3157c-9f9c-4755-808f-f42995cc428a12015-08-04
33342-044-44EA - Each33342-04407fc4c4b-e225-4863-a5ef-c92b5a7024a812015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
METHYL CHLORIDEINACTIVE INGREDIENTA6R43525YOLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ELOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-044LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 5 package rows20230202_85d69d02-c5ef-467e-94aa-903100218795.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN85d69d02-c5ef-467e-94aa-9031002187958
979485losartan potassium 25 MG Oral TabletPSN85d69d02-c5ef-467e-94aa-9031002187958
979492losartan potassium 50 MG Oral TabletPSN85d69d02-c5ef-467e-94aa-9031002187958
979480losartan potassium 100 MG Oral TabletSCD85d69d02-c5ef-467e-94aa-9031002187958
979485losartan potassium 25 MG Oral TabletSCD85d69d02-c5ef-467e-94aa-9031002187958
979492losartan potassium 50 MG Oral TabletSCD85d69d02-c5ef-467e-94aa-9031002187958
979480Losartan K+ 100 MG Oral TabletSY85d69d02-c5ef-467e-94aa-9031002187958
979485Losartan K+ 25 MG Oral TabletSY85d69d02-c5ef-467e-94aa-9031002187958
979492Losartan K+ 50 MG Oral TabletSY85d69d02-c5ef-467e-94aa-9031002187958
979480Losartan Pot 100 MG Oral TabletSY85d69d02-c5ef-467e-94aa-9031002187958
979485Losartan Pot 25 MG Oral TabletSY85d69d02-c5ef-467e-94aa-9031002187958
979492Losartan Pot 50 MG Oral TabletSY85d69d02-c5ef-467e-94aa-9031002187958

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-044-073334200440730 TABLET, FILM COATED in 1 BOTTLE (33342-044-07) 2012-05-100000-00-00NoNoCurrent
33342-044-103334200441090 TABLET, FILM COATED in 1 BOTTLE (33342-044-10) 2012-05-100000-00-00NoNoCurrent
33342-044-123334200441210 BLISTER PACK in 1 CARTON (33342-044-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-05-100000-00-00NoNoCurrent
33342-044-44333420044441000 TABLET, FILM COATED in 1 BOTTLE (33342-044-44) 2016-01-180000-00-00NoNoCurrent