Losartan Potassium and Hydrochlorothiazide (Page 8 of 8)

Package/Label Display Panel

NDC 0093-7367-56

LOSARTAN POTASSIUM and

HYDROCHLOROTHIAZIDE

Tablets USP

50 mg/12.5 mg

Rx only

30 Tablets

Package/Label Display Panel

NDC 0093-7369-56

LOSARTAN POTASSIUM and

HYDROCHLOROTHIAZIDE

Tablets USP

100 mg/12.5 mg

Rx only

30 Tablets

Package/Label Display Panel

NDC 0093-7368-56

LOSARTAN POTASSIUM and

HYDROCHLOROTHIAZIDE

Tablets USP

100 mg/25 mg

Rx only

30 Tablets

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE losartan potassium and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7367 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 50 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 4000 POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE

Product Characteristics Color yellow Score no score Shape OVAL Size 11mm Flavor Imprint Code 93;7367 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-7367-56 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:0093-7367-98 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:0093-7367-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077157 04/06/2010

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE losartan potassium and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7369 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 100 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 4000 POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE

Product Characteristics Color white (white to off-white) Score no score Shape OVAL Size 15mm Flavor Imprint Code 93;7369 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-7369-56 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:0093-7369-98 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:0093-7369-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077157 04/06/2010

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE losartan potassium and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7368 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 100 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 4000 POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE D&C YELLOW NO. 10 ALUMINUM LAKE

Product Characteristics Color yellow (light yellow) Score no score Shape OVAL Size 15mm Flavor Imprint Code 93;7368 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-7368-56 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:0093-7368-98 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:0093-7368-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077157 04/06/2010

Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 08/2020 Teva Pharmaceuticals USA, Inc.