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Author: Admin | 2025-04-28
Strength Strength LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 100 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 4000 TITANIUM DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC Product Characteristics Color white Score no score Shape OVAL Size 15mm Flavor Imprint Code 93;7369 Contains Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72189-098-90 90 TABLET, FILM COATED in 1 BOTTLE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077157 06/12/2020 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE losartan potassium and hydrochlorothiazide tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72189-129(NDC:59746-337) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 50 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE ALUMINUM OXIDE STARCH, CORN HYPROMELLOSES MAGNESIUM STEARATE LACTOSE MONOHYDRATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) TITANIUM DIOXIDE D&C YELLOW NO. 10 Product Characteristics Color yellow Score no score Shape OVAL Size 11mm Flavor Imprint Code C;337 Contains Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72189-129-90 90 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:72189-129-30 30 TABLET, FILM COATED in 1 BOTTLE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201845 10/15/2020 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE losartan potassium and hydrochlorothiazide tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72189-139(NDC:59746-339) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 100 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX TITANIUM DIOXIDE D&C YELLOW NO. 10 ALUMINUM OXIDE CELLULOSE, MICROCRYSTALLINE STARCH, CORN HYPROMELLOSES LACTOSE
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