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 -- 25 mg Tablet Bottle Label
(click image for full-size original)

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 -- 50 mg Tablet Bottle Label
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL -- 100 mg Tablet Bottle Label
(click image for full-size original)
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: 10/2021 Organon LLC

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