COZAAR (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

NDC 78206-121-01

Cozaar^®
(Losartan Potassium
Tablets)

25 mg

Each tablet contains 25 mg of losartan potassium.
Store at 25°C (77°F); excursions permitted to 15-30°C
(59-86°F) [see USP Controlled Room Temperature].
Keep container tightly closed.Protect from light.

Rx only

90 Tablets

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

NDC 78206-122-01

Cozaar^®
(Losartan Potassium
Tablets)

50 mg

Each tablet contains 50 mg of losartan potassium.
Store at 25°C (77°F); excursions permitted to 15-30°C
(59-86°F) [see USP Controlled Room Temperature].
Keep container tightly closed.Protect from light.

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

NDC 78206-123-01

Cozaar^®
(Losartan Potassium
Tablets)

100 mg

Each tablet contains 100 mg of losartan potassium.
Store at 25°C (77°F); excursions permitted to 15-30°C
(59-86°F) [see USP Controlled Room Temperature].
Keep container tightly closed.Protect from light.

Rx only

30 Tablets

COZAAR losartan potassium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-121 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength losartan potassium (losartan) losartan potassium 25 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE LACTOSE MONOHYDRATE STARCH, CORN MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE CARNAUBA WAX

Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code 951 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:78206-121-01 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020386 06/01/2021

COZAAR losartan potassium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-122 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength losartan potassium (losartan) losartan potassium 50 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE LACTOSE MONOHYDRATE STARCH, CORN MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE CARNAUBA WAX

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 952 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:78206-122-01 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:78206-122-02 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020386 06/01/2021

COZAAR losartan potassium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-123 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength losartan potassium (losartan) losartan potassium 100 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE LACTOSE MONOHYDRATE STARCH, CORN MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE CARNAUBA WAX

Product Characteristics Color WHITE Score no score Shape TEAR (teardrop-shaped) Size 12mm Flavor Imprint Code 960 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:78206-123-01 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:78206-123-02 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020386 06/01/2021

Labeler — Organon LLC (117494753)

Revised: 06/2022 Organon LLC