Losortan Potassium

Product NDC
33261-818
11-digit product format
332610818
Labeler code
33261
Product ID
33261-818_1641b016-62df-4c69-bfa4-e7b378e078bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078243
Marketing category
ANDA
Marketing start
2010-10-04
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-818-30Losortan Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
33261-818-60Losortan Potassium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
33261-818-90Losortan Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LOSARTANACTIVE MOIETYJMS50MPO89LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-818LOSORTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140128_8aeb55b8-b570-4c89-a0f8-da0b109a7cfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979485losartan potassium 25 MG Oral TabletPSN8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979492losartan potassium 50 MG Oral TabletPSN8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979480losartan potassium 100 MG Oral TabletSCD8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979485losartan potassium 25 MG Oral TabletSCD8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979492losartan potassium 50 MG Oral TabletSCD8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979480Losartan K+ 100 MG Oral TabletSY8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979485Losartan K+ 25 MG Oral TabletSY8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979492Losartan K+ 50 MG Oral TabletSY8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979480Losartan Pot 100 MG Oral TabletSY8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979485Losartan Pot 25 MG Oral TabletSY8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1
979492Losartan Pot 50 MG Oral TabletSY8aeb55b8-b570-4c89-a0f8-da0b109a7cfc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-818-303326108183030 in 1 BOTTLE, PLASTICHistorical
33261-818-603326108186060 in 1 BOTTLE, PLASTICHistorical
33261-818-903326108189090 in 1 BOTTLE, PLASTICHistorical